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Vo-Quang E, Rosse D, Ortonne V, Garrigou O, Ingiliz P, Leroy V, Pawlotsky JM, Chevaliez S. Performance of the cobas 5800 System for Hepatitis B virus DNA and Hepatitis C virus RNA quantification. Diagn Microbiol Infect Dis 2025; 112:116753. [PMID: 40031380 DOI: 10.1016/j.diagmicrobio.2025.116753] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2025] [Revised: 01/31/2025] [Accepted: 02/17/2025] [Indexed: 03/05/2025]
Abstract
Hepatitis B and C infections are an underdiagnosed global health problem. Measurement of HBV DNA or HCV RNA levels using nucleic acid-based molecular diagnostic assays has been established as the standard of care for assessing diagnosis, guiding the treatment decision, and evaluating responses to antiviral therapy. In the present study, we examined the performance of the cobas 5800 System for HBV DNA and HCV RNA quantification in a large series of patients chronically infected. Specificity of the cobas HBV and HCV Tests on the 5800 System was high (99.1 % and 100 %, respectively). Linearity using the AcroMetrix panels was excellent. Repeatability and intermediate precision coefficients of variation were within 5 %. Of the 334 clinical specimens tested in parallel on the cobas 5800 and cobas 4800 Systems for HBV and the m2000 RealTime or Alinity m Systems for HCV, only 12 (3.6 %) yielded discrepant results that were at or near the limit of quantification of the cobas 5800 assays. The correlation between viral load results was extremely high, and only weak bias were observed across the entire range of concentrations tested without clinical impact in patients who are eligible for antiviral therapy. This comparison study demonstrated equivalent performance of the new cobas 5800 System compared with other molecular platforms widely used in clinical practice for HBV DNA and HCV RNA quantification. The cobas 5800 System can be confidently used in clinical practice. A few clinical specimens with low viral loads may be missed. Further studies are warranted to confirm or refute this finding.
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Affiliation(s)
- Erwan Vo-Quang
- Department of Hepatology, Hôpital Henri Mondor, Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Delphine Rosse
- French National Reference Center for Hepatitis B, C and Delta Viruses, Department of Virology, Hôpital Henri Mondor (AP-HP), Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Valérie Ortonne
- French National Reference Center for Hepatitis B, C and Delta Viruses, Department of Virology, Hôpital Henri Mondor (AP-HP), Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Olivia Garrigou
- French National Reference Center for Hepatitis B, C and Delta Viruses, Department of Virology, Hôpital Henri Mondor (AP-HP), Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Patrick Ingiliz
- Department of Hepatology, Hôpital Henri Mondor, Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Vincent Leroy
- Department of Hepatology, Hôpital Henri Mondor, Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Jean-Michel Pawlotsky
- French National Reference Center for Hepatitis B, C and Delta Viruses, Department of Virology, Hôpital Henri Mondor (AP-HP), Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France
| | - Stéphane Chevaliez
- French National Reference Center for Hepatitis B, C and Delta Viruses, Department of Virology, Hôpital Henri Mondor (AP-HP), Créteil, France; Team Viruses, Hepatology, Cancer", Institut de Recherche Biomédicale, INSERM U955, Créteil, France.
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Zhang D, Zhu Y, Shen Z, Ma S, Liu S, Lu Z. Immunosenescence and immunotherapy in elderly patients with hepatocellular carcinoma. Semin Cancer Biol 2025; 111:60-75. [PMID: 40020977 DOI: 10.1016/j.semcancer.2025.02.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/28/2024] [Revised: 02/11/2025] [Accepted: 02/17/2025] [Indexed: 03/03/2025]
Abstract
Liver cancer, more specifically hepatocellular carcinoma (HCC), is a global health issue and one of the dominant causes of cancer death around the world. In the past few decades, remarkable advances have been achieved in the systemic therapy of HCC. Immune checkpoint inhibitors (ICIs) have become a therapy mainstay for advanced HCC and have shown promise in the neoadjuvant therapy before resection. Despite these significant advancements, the compositions and functions of the immune system occur various alterations with age, called "immunosenescence", which may affect the antitumor effects and safety of ICIs, thus raising concerns that immunosenescence may impair elderly patients' response to ICIs. Therefore, it is important to learn more about the immunosenescence characteristics of elderly patients. However, the real-world elderly HCC patients may be not accurately represented by the elderly patients included in the clinical trials, affecting the generalizability of the efficacy and safety profiles from the clinical trials to the real-world elderly patients. This review summarizes the characteristics of immunosenescence and its influence on HCC progression and immunotherapy efficacy as well as provides the latest progress in ICIs available for HCC and discusses their treatment efficacy and safety on elderly patients. In the future, more studies are needed to clarify the mechanisms of immunosenescence in HCC, and to find sensitive screening tools or biomarkers to identify the patients who may benefit from ICIs.
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Affiliation(s)
- Dengyong Zhang
- Department of General Surgery, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233004, China
| | - Yan Zhu
- Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
| | - Zhengchao Shen
- Department of General Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui 241001, China
| | - Shuoshuo Ma
- Department of General Surgery, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233004, China
| | - Sihua Liu
- Department of General Surgery, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233004, China
| | - Zheng Lu
- Department of General Surgery, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233004, China.
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Pawłowski T, Radkowski M, Perlejewski K, Szymańska B, Berak H, Horban A, Laskus T. Direct-acting antivirals (DAA) positively affect depression and cognitive function in patients with chronic hepatitis C. PLoS One 2025; 20:e0320221. [PMID: 40184345 PMCID: PMC11970650 DOI: 10.1371/journal.pone.0320221] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2024] [Accepted: 02/16/2025] [Indexed: 04/06/2025] Open
Abstract
The aim of the study was to determine how depression and cognitive dysfunction in patients with chronic hepatitis C virus (HCV) infection are affected by treatment with direct-acting antivirals (DAA). Fifty-two chronic hepatitis C patients underwent neurocognitive and psychological evaluation before therapy and 5-6 months later. Depression was measured by Beck Depression Inventory (BDI), anxiety by State-Trait Anxiety inventory (STAI), neuroticism by Eysenck Personality Inventory (N/EPO-R), while Ruff Figural Fluency Test (RFFT), Wisconsin Card Sorting Test (WCST), The Grooved Pegboard Test (GPT), and California Verbal Learning Test (CVLT) were used to assess neurocognitive function. There was significant positive change in BDI scores (8.8 ± 6.6 vs 6.1 ± 6.1; p < 0.0001) while the most striking improvement in cognitive tests was observed for CVLT sum of immediate recall from Trial-1 to Trial-5 (50.9 ± 10.0 to 54.1 ± 10.0; p = 0.0005) and RFFT, where the number of unique designs increased from 77.2 ± 21.0 to 86.1 ± 28.3 (p < 0.0001). These differences remained significant when patients with advanced (METAVIR grade F3/F4) and those with mild (grade F0/F1/F2) liver disease were analyzed separately, although in general the improvements were more pronounced in the former group. In conclusion, in chronic HCV infection the brain function is markedly improved by DAA treatment.
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Affiliation(s)
- Tomasz Pawłowski
- Department of Psychiatry, Wrocław Medical University, Wrocław, Poland
| | - Marek Radkowski
- Department of Immunopathology of Infectious and Parasitic Diseases, Medical University of Warsaw, Warsaw, Poland
| | - Karol Perlejewski
- Department of Immunopathology of Infectious and Parasitic Diseases, Medical University of Warsaw, Warsaw, Poland
| | - Bogna Szymańska
- Outpatient Clinic, Warsaw Hospital for Infectious Diseases, Warsaw, Poland
| | - Hanna Berak
- Outpatient Clinic, Warsaw Hospital for Infectious Diseases, Warsaw, Poland
| | - Andrzej Horban
- Department of Adult Infectious Diseases, Medical University of Warsaw, Warsaw, Poland
| | - Tomasz Laskus
- Department of Adult Infectious Diseases, Medical University of Warsaw, Warsaw, Poland
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Choi HY, Ki M. Temporal and geospatial patterns of hepatitis C virus prevalence: a longitudinal examination using national health insurance service data in the Republic of Korea (2005-2022). BMC Public Health 2025; 25:1248. [PMID: 40181319 PMCID: PMC11967032 DOI: 10.1186/s12889-025-21777-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2024] [Accepted: 02/04/2025] [Indexed: 04/05/2025] Open
Abstract
BACKGROUND Viral hepatitis, recognized as a significant global public health threat by the World Health Organization (WHO), has spurred efforts to establish elimination goals by 2030. In Republic of Korea (Korea), the prevalence of Hepatitis C virus (HCV) infection exhibits significant regional disparities, necessitating tailored infection control measures at the regional level. This study aimed to analyze the HCV prevalence trend by area (region/town) in Korea, from 2005 to 2022, and identify the areas requiring priority management. METHODS A comprehensive analysis of HCV prevalence trends across different geographical regions and towns from 2005 to 2022 was conducted. Using data from the National Health Insurance Service, individuals diagnosed with acute or chronic HCV during this period were included in the analysis. HCV prevalence was adjusted by area, year, sex, and age. Additionally, trends in annual percent changes (APC) and average APC (AAPC) in HCV prevalence were examined using Joinpoint regression analysis. RESULTS Age, sex, and region adjusted HCV prevalence per 100,000 people declined from 151 in 2005 to 98 in 2022. During the 18 years, the highest HCV prevalence was recorded in the southern regions of Korea (Busan, Jeonnam, and Gyeongnam) and in the towns of Namhae-gun of Gyeongnam, Boeun-gun of Chungbuk, and Sunchang-gun of Jeonbuk. The age-, sex-, and region-adjusted annual HCV prevalence decreased significantly at an APC of -2.5% (95% confidence interval [CI]: -3.5, -1.4) and AAPC of -2.7% (95%CI: -4.3, -1.0). By town, the prevalence decreased the most in Boeun-gun of Chungbuk (AAPC: -23.7%; 95%CI: -30.2, -16.5) and increased the most in Gunwi-gun of Gyeongbuk (AAPC: 3.0%; 95%CI: 1.1, 4.9). CONCLUSIONS Over 18 years, a notable decline in HCV prevalence was observed in Korea, although this trend exhibited regional disparities. To effectively achieve the WHO hepatitis elimination goals by 2030, targeted interventions should prioritize areas with persistent or emerging prevalence.
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Affiliation(s)
- Hwa Young Choi
- Department of Public Health & AI, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Republic of Korea
| | - Moran Ki
- Department of Public Health & AI, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Republic of Korea.
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Zheng Q, He Y, Zhu Q, Wang C, Nie X. Evaluation of an anti-HCV chemiluminescence assay: Enhancing diagnostic accuracy and reducing false positives in hepatitis C screening. Diagn Microbiol Infect Dis 2025; 112:116829. [PMID: 40185012 DOI: 10.1016/j.diagmicrobio.2025.116829] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/03/2025] [Revised: 03/14/2025] [Accepted: 03/31/2025] [Indexed: 04/07/2025]
Abstract
OBJECTIVES Detection of antibodies is recommended for the diagnosis and effective treatment of hepatitis C. This study evaluated the performance of a new chemiluminescence assay for detecting hepatitis C virus (HCV) antibodies and compared it with previous assays using a comprehensive set of routine and borderline samples. METHODS A total of 2,216 serum samples were included in this study, comprising of 2,121 routine clinical samples and 95 borderline cases (COI range: 0.9-5.0). We compared the Anti-HCV-2 assay's (Mindray Diagnostics, Shenzhen, China) performance with the Anti-HCV-1 assay, assessing key parameters including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Precision was tested using replicate samples, and accuracy was validated through confirmatory RIBA (Mikrogen GmbH, Neuried, Germany) and Elecsys Anti-HCV assays (Roche Diagnostics, Mannheim, Germany). Interference testing was conducted to assess the assay's robustness against common substances found in clinical samples. RESULTS The Anti-HCV-2 assay demonstrated high sensitivity (98.2 %), specificity (99.1 %), and accuracy (98.7 %) in routine clinical samples. For borderline cases, the accuracy of Anti-HCV-2 was significantly higher (96.84 %) compared to Anti-HCV-1 (3.16 %). Precision testing showed a coefficient of variation (CV) of <2 %, indicating excellent reproducibility. Anti-interference testing confirmed that the Anti-HCV-2 assay performed consistently across samples with common interferences, such as hemolysis and lipemia. CONCLUSION The Anti-HCV-2 assay outperforms the Anti-HCV-1 assay in terms of accuracy, reproducibility, and reliability, especially in the range of borderline, making it a valuable tool for routine HCV screening.
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Affiliation(s)
- Qingyuan Zheng
- Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan, China; Clinical Laboratory Medicine Research Center of West China Hospital, Chengdu, Sichuan, China
| | - Yong He
- Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan, China; Clinical Laboratory Medicine Research Center of West China Hospital, Chengdu, Sichuan, China
| | - Quanjing Zhu
- Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan, China; Clinical Laboratory Medicine Research Center of West China Hospital, Chengdu, Sichuan, China
| | - Chi Wang
- Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan, China; Clinical Laboratory Medicine Research Center of West China Hospital, Chengdu, Sichuan, China
| | - Xin Nie
- Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan, China; Clinical Laboratory Medicine Research Center of West China Hospital, Chengdu, Sichuan, China.
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Iwadare T, Kimura T, Sugiura A, Okumura T, Wakabayashi S, Kobayashi H, Yamashita Y, Yamazaki T, Joshita S, Tanaka N, Umemura T. Thrombospondin 2 as a Predictive Biomarker for HCC in Hepatitis C Patients: A Longitudinal Study Following DAA Therapy. J Viral Hepat 2025; 32:e14025. [PMID: 39403792 PMCID: PMC11883454 DOI: 10.1111/jvh.14025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2024] [Revised: 09/24/2024] [Accepted: 09/30/2024] [Indexed: 02/11/2025]
Abstract
This multicentre study investigated the dynamics of thrombospondin 2 (TSP2) levels during direct-acting antiviral (DAA) therapy in hepatitis C virus (HCV) infected patients and evaluated TSP2's potential as a predictive marker for hepatocellular carcinoma (HCC). All 134 participants achieved sustained virological response at 12 weeks (SVR12) with DAA therapy, and serum TSP2 levels significantly decreased from before and after treatment (p < 0.001). During the median follow-up period of 6.0 years, HCC after DAA therapy was observed in 16 patients (11.9%). Patients with serum TSP2 High (≥ 32 ng/mL) at SVR12 had a significantly higher cumulative occurrence of HCC than did those without (26.5% vs. 7.0%, p = 0.0033). A multivariate Cox proportional hazards model identified male gender (HR 4.84, p = 0.005), HCC history (HR 4.61, p = 0.017) and TSP2 High (HR 3.93, p = 0.009) as significant independent predictors of HCC occurrence after DAA therapy. The model had a high concordance index of 0.878. Additionally, combining TSP2 High and FIB-4 High (≥ 3.538) at SVR12 yielded high specificity and negative predictive value (0.941 and 0.917, respectively) for predicting HCC. Kaplan-Meier analysis showed a higher HCC incidence in the TSP2 High + FIB-4 High group (log-rank p < 0.0001). In conclusion, TSP2 may be a promising biomarker for personalised HCC surveillance in DAA-treated hepatitis C patients.
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Affiliation(s)
- Takanobu Iwadare
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
| | - Takefumi Kimura
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
- Consultation Center for Liver DiseasesShinshu University HospitalMatsumotoNaganoJapan
| | - Ayumi Sugiura
- Department of Internal MedicineSato HospitalNakanoNaganoJapan
| | - Taiki Okumura
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
| | - Shun‐ichi Wakabayashi
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
| | - Hiroyuki Kobayashi
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
| | - Yuki Yamashita
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
- Consultation Center for Liver DiseasesShinshu University HospitalMatsumotoNaganoJapan
| | - Tomoo Yamazaki
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
- Department of MedicineUniversity of California San DiegoLa JollaCaliforniaUSA
| | - Satoru Joshita
- Department of Internal MedicineYodakubo HospitalNagawaNaganoJapan
| | - Naoki Tanaka
- Department of Global Medical Research PromotionShinshu University Graduate School of MedicineMatsumotoNaganoJapan
- International Relations OfficeShinshu University School of MedicineMatsumotoNaganoJapan
- Research Center for Social SystemsShinshu UniversityMatsumotoNaganoJapan
| | - Takeji Umemura
- Division of Gastroenterology and Hepatology, Department of MedicineShinshu University School of MedicineMatsumotoNaganoJapan
- Consultation Center for Liver DiseasesShinshu University HospitalMatsumotoNaganoJapan
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Liu CH, Cheng PN, Fang YJ, Chen CY, Kao WY, Lin CL, Yang SS, Shih YL, Peng CY, Chang YP, Huang SC, Su TH, Tseng TC, Liu CJ, Chen PJ, Kao JH. Risk of de novo HCC in patients with MASLD following direct-acting antiviral-induced cure of HCV infection. J Hepatol 2025; 82:582-593. [PMID: 39368711 DOI: 10.1016/j.jhep.2024.09.038] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/07/2024] [Revised: 09/12/2024] [Accepted: 09/20/2024] [Indexed: 10/07/2024]
Abstract
BACKGROUND & AIMS Data are limited on the risk of de novo hepatocellular carcinoma (HCC) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) who have achieved sustained virologic response at off-treatment week 12 (SVR12) using direct-acting antivirals (DAAs) for HCV. METHODS A total of 1,598 eligible patients received biannual alpha-fetoprotein (AFP) and liver imaging surveillance to detect de novo HCC after achieving SVR12. MASLD was defined as presence of controlled attenuation parameter (CAP) ≥248 dB/m and ≥1 cardiometabolic risk factor (CMRF). Cumulative HCC incidence was compared between patients with/without MASLD. We built univariable and multivariable Cox proportional hazards models to evaluate factors associated with HCC. Sensitivity analysis was performed using the Fine-Gray subdistribution hazards model. Additionally, we evaluated the mediation effect of MASLD on CMRFs and of CMRFs on MASLD for HCC using mediation analysis with bootstrapping. RESULTS The incidence rate of HCC was 1.44 per 100 person-years of follow-up (95% CI 1.19-1.74). Patients with MASLD had a higher cumulative HCC incidence than those without MASLD (log-rank test, p <0.001). Multivariable Cox regression analysis revealed that in addition to age, sex, liver stiffness measurement, platelet count, and AFP, MASLD (adjusted hazard ratio 2.07; 95% CI 1.36-3.16; p <0.001) was independently associated with HCC. This finding was confirmed by the Fine-Gray model, which showed a subdistribution hazard ratio of 2.07 (95% CI 1.34-3.19, p <0.001) for MASLD. MASLD significantly mediated CMRFs for HCC development. CONCLUSION After achieving SVR12, patients with MASLD exhibited an increased HCC risk compared to those without MASLD. Vigilant HCC surveillance and control of CMRFs to mitigate the effect of MASLD on HCC remain crucial for this population. IMPACT AND IMPLICATIONS The risk of de novo hepatocellular carcinoma (HCC) among patients with metabolic dysfunction-associated steatotic liver disease (MASLD) who have attained a sustained virologic response to direct-acting antivirals remains to be confirmed. In this study, recruiting 1,598 patients in Taiwan, individuals with MASLD had an approximately two-fold increased risk of de novo HCC compared to those without MASLD after achieving a sustained virologic response. MASLD significantly mediated cardiometabolic risk factors for HCC development. Our findings underscore the critical importance of pharmacological interventions and proactive lifestyle modifications to control cardiometabolic risk factors in patients with MASLD, as well as the need for vigilant HCC surveillance to ensure favorable outcomes following HCV eradication.
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Affiliation(s)
- Chen-Hua Liu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan
| | - Pin-Nan Cheng
- Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan
| | - Yu-Jen Fang
- Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan
| | - Chi-Yi Chen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan
| | - Wei-Yu Kao
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; TMU Research Center for Digestive Medicine, Taipei Medical University, Taipei, Taiwan; Taipei Cancer Center, Taipei Medical University, Taipei, Taiwan
| | - Chih-Lin Lin
- Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan
| | - Sheng-Shun Yang
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; School of Medicine, Chung Shan Medical University, Taichung, Taiwan; Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan
| | - Yu-Lueng Shih
- Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
| | - Cheng-Yuan Peng
- Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan; School of Medicine, China Medical University, Taichung, Taiwan
| | - Yu-Ping Chang
- Department of Internal Medicine, National Taiwan University Biomedical Park Hospital, Hsin-Chu, Taiwan
| | - Shang-Chin Huang
- Department of Internal Medicine, National Taiwan University Hospital Bei-Hu Branch, Taipei, Taiwan
| | - Tung-Hung Su
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
| | - Tai-Chung Tseng
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan
| | - Chun-Jen Liu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan
| | - Pei-Jer Chen
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan
| | - Jia-Horng Kao
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
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8
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Artenie A, Trickey A, Looker KJ, Stone J, Lim AG, Fraser H, Degenhardt L, Dore GJ, Grebely J, Cunningham EB, Hazarizadeh B, Low-Beer D, Luhmann N, Webb P, Hickman M, Vickerman P. Global, regional, and national estimates of hepatitis C virus (HCV) infection incidence among people who inject drugs and number of new annual HCV infections attributable to injecting drug use: a multi-stage analysis. Lancet Gastroenterol Hepatol 2025; 10:315-331. [PMID: 39993400 DOI: 10.1016/s2468-1253(24)00442-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2024] [Revised: 12/19/2024] [Accepted: 12/20/2024] [Indexed: 02/26/2025]
Abstract
BACKGROUND Measuring progress towards the WHO 2030 target for hepatitis C virus (HCV) elimination among people who inject drugs (PWID)-an incidence of two or fewer infections per 100 person-years-has been challenging due to insufficient data. We aimed to estimate HCV incidence among PWID before and since 2015, progress towards the 2030 target, and the number of new annual HCV infections attributable to injecting drug use since 2015. METHODS Four sequential steps were taken to estimate country-specific HCV incidence. First, we estimated HCV incidence from HCV antibody prevalence by duration of injecting using force-of-infection (FOI) modelling. Second, using Bayesian random-effects meta-analysis, we pooled FOI-derived estimates with any direct HCV incidence estimates from a published global meta-analysis, by country. Third, for countries with no FOI-derived or direct HCV incidence data, we applied incidence estimates from a published multi-country dynamic mathematical model. Fourth, for countries for which incidence could not be estimated using any of the aforementioned methods but that had data on overall HCV antibody prevalence (ie, not stratified by duration of injecting), we used a regression model to predict incidence based on prevalence and average duration of injecting. WHO regional and global HCV incidence, incidence rate ratios (IRRs) for 2015-21 versus pre-2015, and relative decline needed to achieve the 2030 WHO target were derived and weighted by the country-specific number of PWID at risk (ie, those who were HCV RNA-negative), provided that data from at least five countries were available within a WHO region. New annual HCV infections attributable to injecting drug use were estimated by multiplying country-specific HCV incidence for the 2015-21 period by the number of HCV RNA-negative PWID; for countries with no HCV incidence data but with evidence of an existing PWID population, incidence was imputed using the corresponding WHO regional incidence. FINDINGS For the pre-2015 period, 146 HCV incidence estimates from 81 countries were included: 52 (36%) direct, 61 (42%) FOI-derived, and 33 (23%) regression-based estimates. For 2015-21, 114 estimates from 97 countries were included: 20 (18%) direct, 18 (16%) FOI-derived, 68 (60%) dynamic model-derived, and eight (7%) regression-based. Globally, pooled HCV incidence was 13·9 per 100 person-years (95% uncertainty interval [UI] 11·9-16·4) for pre-2015 and 8·6 per 100 person-years (7·1-10·7) for 2015-21. Based on a subset of countries with data for both periods, incidence was lower in the Western Pacific (IRR 0·32 [95% UI 0·23-0·50]), Eastern Mediterranean (0·67 [0·50-0·89]), and European (0·79 [0·63-1·02]) regions in 2015-21 versus pre-2015, but no difference was observed in the Americas. Insufficient data prevented comparisons over time for the African and South-East Asia regions and globally. Based on 2015-21 HCV incidence, the global decline needed to meet the 2030 WHO target is 76·7% (95% UI 71·8-81·3), while the global number of new annual HCV infections attributable to injecting drug use was 833 760 (95% UI 493 716-1 544 395) among the 187 countries with documented evidence of a population of PWID. INTERPRETATION A substantial increase in HCV treatment and prevention is needed globally to achieve the WHO 2030 HCV elimination target for incidence among PWID. FUNDING WHO and the Wellcome Trust.
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Affiliation(s)
- Adelina Artenie
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
| | - Adam Trickey
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Katharine J Looker
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Jack Stone
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Aaron G Lim
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Hannah Fraser
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Louisa Degenhardt
- National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia
| | - Gregory J Dore
- The Kirby Institute, University of New South Wales, Sydney, NSW, Australia
| | - Jason Grebely
- The Kirby Institute, University of New South Wales, Sydney, NSW, Australia
| | - Evan B Cunningham
- The Kirby Institute, University of New South Wales, Sydney, NSW, Australia
| | - Behzad Hazarizadeh
- The Kirby Institute, University of New South Wales, Sydney, NSW, Australia
| | - Daniel Low-Beer
- Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, World Health Organization, Geneva, Switzerland
| | - Niklas Luhmann
- Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, World Health Organization, Geneva, Switzerland
| | - Paige Webb
- National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia
| | - Matthew Hickman
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia
| | - Peter Vickerman
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
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9
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Flisiak R, Rzymski P, Flisiak-Jackiewicz M, Brzdęk M, Zarębska-Michaluk D. Treatment of chronic hepatitis C infection: strategies to address poor therapy adherence. Expert Rev Anti Infect Ther 2025:1-9. [PMID: 40156354 DOI: 10.1080/14787210.2025.2486353] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2025] [Accepted: 03/20/2025] [Indexed: 04/01/2025]
Abstract
INTRODUCTION Non-adherence to any therapy may be related to skipping drug doses, discontinuation of therapy, or loss of follow-up. It leads to the ineffectiveness of treatment, which is associated with obvious individual health losses, significant social and financial costs, and, in the case of infectious diseases, epidemiological consequences resulting from the possibility of further spread of infection. AREAS COVERED This review article analyses the causes and effects of non-adherence to treatment in patients infected with the hepatitis C virus (HCV). It also presents strategies to reduce the risk of non-adherence, which can be implemented by simplifying the treatment process, improving the flow of information between the doctor and the patient, as well as improving patients' knowledge about hepatitis C infection, and facilitating the understanding of the risks associated with non-adherence. EXPERT OPINION Since the treatment of HCV infections is highly effective in almost all patients who complete medication, no new drugs are to be expected in the coming years. Therefore, the primary attention in the global elimination of HCV will be focused on screening programs, improving the availability of drugs, and reducing the risk of non-adherence.
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Affiliation(s)
- Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland
| | - Piotr Rzymski
- Department of Environmental Medicine, Poznan University of Medical Sciences, Poznań, Poland
| | - Marta Flisiak-Jackiewicz
- Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok, Bialystok, Poland
| | - Michał Brzdęk
- Collegium Medicum, Jan Kochanowski University, Kielce, Poland
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10
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Fan R, Liang Q, Sui Y, Yang Y, Yuan X. The next viral pandemic-where do we stand? Folia Microbiol (Praha) 2025:10.1007/s12223-025-01256-6. [PMID: 40153131 DOI: 10.1007/s12223-025-01256-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 03/16/2025] [Indexed: 03/30/2025]
Abstract
The world is presently undergoing a recovery phase following the unexpected challenges posed by the coronavirus disease 2019 (COVID-19) pandemic. The loss of lives and the economic setbacks experienced by the global population will require considerable time to address. It is clear that future outbreaks, epidemics, or even pandemic caused by unknown bacterial, fungal, or viral pathogens are inevitable. In this context, public health front-liners will be essential in minimizing the impact of such incidents. This mini-review briefly discusses sociocultural issues, diagnostic capacities, surveillance, and screening strategies for potential future viral pandemic - referred to as Pandemic X. Additionally, it addresses treatment responses, vaccine development efforts, scientific advancements, policy considerations, and prospects for science communication related to forthcoming viral pandemics. While this review does not encompass all scientific approaches available on these topics, it aims to serve as a guideline for informing public health sectors about appropriate measures that should be undertaken.
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Affiliation(s)
- Rui Fan
- Graduate School, Heilongjiang University of Chinese Medicine, Harbin, 150040, China
| | - Qun Liang
- Department of Critical Care Medicine, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, No. 24 Heping Road, Xiangfang District, Harbin, 150040, Heilongjiang, People's Republic of China.
| | - Yanbo Sui
- Department of General Medicine, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China
| | - Yang Yang
- Department of Critical Care Medicine, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, No. 24 Heping Road, Xiangfang District, Harbin, 150040, Heilongjiang, People's Republic of China
| | - Xingxing Yuan
- Graduate School, Heilongjiang University of Chinese Medicine, Harbin, 150040, China
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11
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Sazzad HMS, Li H, Hajarizadeh B, Horsburgh BA, Grebely J, Dore GJ, Bull RA, Lloyd AR, Rodrigo C. Estimating the impact of direct acting antiviral therapy on the prevalence of hepatitis C virus infection using phylogenetics. Virus Res 2025; 355:199566. [PMID: 40154796 DOI: 10.1016/j.virusres.2025.199566] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2025] [Revised: 03/24/2025] [Accepted: 03/26/2025] [Indexed: 04/01/2025]
Abstract
INTRODUCTION Australia has provided unrestricted subsidized access to direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection since 2016. Epidemiological surveillance estimates suggest prevalence of chronic HCV infection has declined since 2016, but these estimates are not separated by genotype and may not capture 'hidden' infected populations, notably the most marginalized groups affected, including people who inject drugs and people in prison. This study used phylogenetics to assess whether epidemiological estimates of declining HCV prevalence in the prisons of New South Wales, Australia due to DAA scale up could be reproduced. METHOD Near-full-length 280 HCV consensus sequences (GT1a: n = 140, GT3a: n = 140) sampled between 2006 - 2019 from two prison-based cohort studies in NSW were used for phylogenetic estimates. These included 110 acute infection sequences (GT1a: n = 48, GT3a: n = 62) which were considered in a separate sensitivity analysis given the differences in virus mutation rates in acute and chronic infection. Changes in the effective population size of infected people for each genotype were explored with BEAST software suite (v1.10) using a coalescent Bayesian skyline approach. RESULTS Both the main and sensitivity analyses for GT3a showed a reduction in the effective population size with the latter showing a 36 % decline between 2011-2019 which is more concordant with the decline estimated from non-phylogenetic methods. A decline of similar magnitude was not demonstrated for GT1a. Overall, the analyses using acute infection sequences only were closer to the trends of independent epidemiological estimates. CONCLUSIONS An adequately powered Bayesian evolutionary analysis using acute stage infection sequences may reproduce the decline in HCV infections observed by traditional epidemiological methods during DAA scale up.
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Affiliation(s)
| | - Hui Li
- Kirby Institute, UNSW, 2052 Sydney, NSW, Australia
| | | | | | | | | | - Rowena A Bull
- Kirby Institute, UNSW, 2052 Sydney, NSW, Australia; School of Biomedical Sciences, UNSW 2052, NSW, Australia
| | | | - Chaturaka Rodrigo
- Kirby Institute, UNSW, 2052 Sydney, NSW, Australia; School of Biomedical Sciences, UNSW 2052, NSW, Australia.
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12
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Haji-Maghsoudi S, Tavakoli F, Mehmandoost S, Nasiri N, Haghdoost AA, Sharifi H. The association between drug injection duration and hepatitis C prevalence among people who inject drugs in Iran. Sci Rep 2025; 15:10208. [PMID: 40133391 PMCID: PMC11937450 DOI: 10.1038/s41598-025-94867-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2024] [Accepted: 03/17/2025] [Indexed: 03/27/2025] Open
Abstract
People who inject drugs (PWID) are at higher risk of hepatitis C virus (HCV) due to their behaviors such as shared injection. Employing appropriate modeling approaches is crucial for accurately evaluating the impact of other variables on outcomes, in this case, HCV seropositivity. This study aimed to assess the non-linear effect of injection duration on HCV seropositivity. From July 2019 to March 2020, 2,684 PWID in Iran were recruited. The binary outcome variable was HCV serostatus (positive vs. negative), determined by detecting HCV antibodies. The non-linear effect of injection duration on HCV seropositivity was assessed using a multilevel Generalized Additive Model in R software, adjusting the effects of other variables in the analysis. We found a non-linear effect of injection duration on HCV seropositivity status (p-value < 0.001). The probability of HCV seropositivity increased with injection duration, though this relationship was non-linear. Initially, the probability rises faster; however, this effect diminishes as the injection duration extends. An initial sharp increase in HCV risk was seen during the first 20 years of injection. HCV seropositivity was notably associated with ever HIV seropositivity (OR [Odds Ratio] = 10.54, 95% CI [Confidence Interval]: 5.39, 20.61, p-value < 0.001), ever having injected methamphetamine (OR = 1.72, 95% CI: 1.33, 2.22, p-value < 0.001), being currently married (OR = 0.67, 95% CI: 0.48, 0.93, p-value = 0.018), ever shared needle/syringe with others (OR = 2.63, 95% CI: 1.32, 5.22, p-value = 0.006), and ever being incarcerated (OR = 1.97, 95% CI: 1.50, 2.58, p-value < 0.001). Our study contributes to the field by demonstrating that a non-linear approach can reveal patterns of risk that linear models might fail to capture. These findings indicate that the relationship between injection duration and HCV seropositivity can be more complex than previously understood, underscoring the importance of employing more advanced modeling techniques in future research.
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Affiliation(s)
- Saiedeh Haji-Maghsoudi
- Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Fatemeh Tavakoli
- HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Soheil Mehmandoost
- HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Naser Nasiri
- HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
- Department of Epidemiology and Biostatistics, School of Public Health, Jiroft University of Medical Sciences, Jiroft, Iran
| | - Ali Akbar Haghdoost
- Social Determinants of Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Hamid Sharifi
- HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.
- Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.
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13
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Li M, Wulayin K, Ma S, Zhou L, Lin S, Wu C, Chen L. Epidemiological characteristics and treatment challenges of chronic hepatitis C in the kashi region of xinjiang china: A retrospective investigation from 2018 to 2022. Sci Rep 2025; 15:9726. [PMID: 40118953 PMCID: PMC11928459 DOI: 10.1038/s41598-025-94626-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2024] [Accepted: 03/17/2025] [Indexed: 03/24/2025] Open
Abstract
Due to the emergence of direct-acting antiviral (DAA), more attention has been devoted to the prevalence and antiviral treatment of chronic hepatitis C in the Kashi region of Xinjiang, China, over the past decade. This study aimed to investigate the epidemiology, genotype (GT) distribution, diagnosis, and antiviral treatment of chronic hepatitis C virus (HCV) infection in this region from 2018 to 2022 and to highlight the challenges in achieving effective management. This retrospective study included individuals with HCV antibody (HCV-Ab) positivity at the First People's Hospital of Kashi from January 1, 2018, to August 31, 2022. Clinical data, including HCV RNA data, GT distribution, and DAA treatment history, were collected. Patients were followed up via telephone to assess treatment adherence and reasons for refusal. The HCV-Ab positivity rate increased from 1.7% in 2018 to 2.9% in 2022. Among the 4,928 HCV-Ab-positive individuals, 2174 (44%) underwent HCV RNA testing, with 1,088 (22%) confirmed positive. Of these patients, 707 were genotyped, with GT1b (70.7%) being the most prevalent GT. Due to limited access to DAA, only 327 (30%) RNA-positive patients received antiviral treatment, 243 (74%) of whom completed the course. Barriers to receiving DAA included high costs, low disease awareness, and limited healthcare access. These findings underscore the severity of the chronic HCV epidemic in Kashi, where healthcare access is inadequate, including limited HCV RNA testing and DAA treatment coverage. Tailored public health interventions and improvements in healthcare infrastructure are essential for better managing chronic HCV infection in this high-burden region.
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Affiliation(s)
- Mingna Li
- Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong, China
| | - Kuerbannisa Wulayin
- Department of Infectious Diseases, The First People's Hospital of Kashi, 120 Yingbin Avenue, Kashi, 844000, Xinjiang, China
| | - Shasha Ma
- Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong, China
| | - Lian Zhou
- Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong, China
| | - Shutao Lin
- Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong, China
| | - Chao Wu
- Department of Infectious Diseases, The First People's Hospital of Kashi, 120 Yingbin Avenue, Kashi, 844000, Xinjiang, China.
| | - Lubiao Chen
- Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong, China.
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14
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McGourty CA, Ung D, Clark M, Nguyen J, McDonell C, Luetkemeyer A, McKinney J, Price JC, Morris MD. Facilitating access to direct-acting antivirals in a community-based point-of-diagnosis model for hepatitis C treatment: The role of the pharmacy team in the no one waits (NOW) study. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2025; 139:104768. [PMID: 40088600 DOI: 10.1016/j.drugpo.2025.104768] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2024] [Revised: 02/24/2025] [Accepted: 03/03/2025] [Indexed: 03/17/2025]
Abstract
BACKGROUND Despite simplified hepatitis C virus (HCV) treatment algorithms, insurance-related barriers prevent same-day HCV treatment upon diagnosis in the US. We assessed how direct partnerships with a pharmacy team facilitated HCV treatment initiation among socially marginalized populations in a community setting. METHODS The No One Waits (NOW) Study, a single-arm trial conducted between July 1, 2020, and October 31, 2021, in San Francisco, CA, targeted individuals experiencing homelessness, injecting drugs, and eligible for simplified HCV treatment. Upon positive HCV RNA results, participants were enrolled in same-day treatment and given a 2-week sofosbuvir/velpatasvir (SOF/VEL) starter pack. Additional insurance-provided SOF/VEL was requested for 12 weeks of treatment. If insurance-provided medication was unavailable, SOF/VEL was provided using the study supply. We describe the sustained partnership with a specialty pharmacy team that was necessary for the NOW model's success. RESULTS Eighty-seven participants started treatment at diagnosis. Most were unsheltered (61 %), actively injecting drugs (80 %), and had incomes below the federal poverty line (97 %). 90 % transitioned to insurance-covered treatment before completion, with pharmacy members assisting participants in navigating insurance authorization, medication transport, and financial assistance. CONCLUSION A sustained partnership with a specialty pharmacy team was critical in transitioning participants to insurance-covered treatment quickly and overcoming barriers, while the study-provided 2-week starter pack facilitated same-day treatment at the point of diagnosis.
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Affiliation(s)
- Colleen A McGourty
- Department of Medicine, University of California San Francisco (UCSF), USA
| | | | | | | | | | - Annie Luetkemeyer
- Department of Medicine, University of California San Francisco (UCSF), USA
| | - Jeff McKinney
- Department of Medicine, University of California San Francisco (UCSF), USA
| | - Jennifer C Price
- Department of Medicine, University of California San Francisco (UCSF), USA
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15
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Dai S, Wang Z, Guo Q, Tang G, Guo Q, Zhang J, Fan Y. Awareness of hepatitis C prevention and treatment and high-risk behaviors among the general population in Anhui Province: a cross-sectional study. Front Public Health 2025; 13:1534169. [PMID: 40144995 PMCID: PMC11936984 DOI: 10.3389/fpubh.2025.1534169] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2024] [Accepted: 02/24/2025] [Indexed: 03/28/2025] Open
Abstract
Background The World Health Organization (WHO) set the goal of "eliminating viral hepatitis as a major public health threat by 2030" in 2016. In 2021, the National Health Commission of China (NHCC), issued an action plan to help achieve the WHO's goal of eliminating the Hepatitis C virus by 2030. Therefore, the primary objective of this study was to investigate the awareness of knowledge of hepatitis C prevention and treatment and high-risk behaviors among the general population of Anhui Province. Methods Stratified sampling method had been used to select participants to conduct a survey from June 2021 to September 2021 in Anhui Province. Multivariate logistic regression model was used to reveal the influencing factors of participants' awareness and the self-selected high-risk behaviors of HCV infection. Results The crude and standard awareness rates of hepatitis C were 56.12% (95% CI: 54.15-58.11%) and 53.74% (95% CI: 53.72-53.75%), respectively. Among the 2,423 participants, 83.2% knew that blood or blood products can lead to hepatitis C infection, but only 44.2% knew that people infected with HCV can look healthy. Multivariate logistic regression model analysis showed that age group, education level, and geographic location were the important factors influencing hepatitis C awareness. In the last year, 1,113 people (45.9%) reported that they had high-risk behaviors for hepatitis C infection. Multivariate logistic regression model analysis revealed that hepatitis C awareness, gender, marital status, and geographic location were the important factors influencing the self-selected high-risk behaviors. Conclusion The findings indicated that the general population in Anhui Province has low awareness of HCV prevention and treatment and a certain degree of history of high-risk behavior for hepatitis C. In the future, more information and health education on hepatitis C is needed, with particular attention to the older adult, those with low education levels, and the central and southern regions of Anhui Province. We also should strengthen the education of females and married, divorced or widowed individuals to recognize and avoid high-risk behaviors for hepatitis C in their lives. By narrowing the gap between knowledge and behavior, we can contribute to the goal of eliminating hepatitis C by 2030.
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Affiliation(s)
- Seying Dai
- Anhui Provincial Center for Disease Control and Prevention, Hefei, Anhui, China
| | - Ziwei Wang
- Department of Epidemiology and Health Statistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China
| | - Qian Guo
- Department of Epidemiology and Health Statistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China
| | - Gan Tang
- Department of Epidemiology and Health Statistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China
| | - Qisheng Guo
- Department of Epidemiology and Health Statistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China
| | - Jin Zhang
- Anhui Provincial Center for Disease Control and Prevention, Hefei, Anhui, China
| | - Yinguang Fan
- Department of Epidemiology and Health Statistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China
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16
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Zhu SH, Zhu NX, Ye XT, Huang HQ, Yang YD, Yan D. Establishment and effectiveness verification of a new pattern for hepatitis C elimination in hospital. Hepatobiliary Pancreat Dis Int 2025:S1499-3872(25)00054-2. [PMID: 40121096 DOI: 10.1016/j.hbpd.2025.03.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/09/2024] [Accepted: 03/10/2025] [Indexed: 03/25/2025]
Affiliation(s)
- Si-Heng Zhu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
| | - Ning-Xin Zhu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
| | - Xiao-Ting Ye
- Department of Infectious Diseases, Rui'an People's Hospital, Wenzhou 325200, China
| | - He-Qing Huang
- Department of Infectious Diseases, Zhuji People's Hospital, Shaoxing 311800, China
| | - Yi-Da Yang
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
| | - Dong Yan
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
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17
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Phillips LT, Bradshaw D, Packer S, Simmons R, Rosenberg WM, Sabin CA, Mbisa JL. Direct-acting antiviral treatment outcomes in people infected with endemic compared to epidemic hepatitis C virus subtypes in England. J Infect 2025; 90:106465. [PMID: 40054668 DOI: 10.1016/j.jinf.2025.106465] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2024] [Accepted: 03/01/2025] [Indexed: 03/16/2025]
Abstract
BACKGROUND Current evidence suggests reduced efficacy of direct-acting antiviral (DAA) treatment among people with endemic Hepatitis C virus (HCV) subtypes rare to high-income countries. We aimed to determine real-world DAA treatment outcomes of people with endemic HCV subtypes in England. METHODS Data were collected through a national treatment program. People who had their virus subtyped between 2019-2023, were resident in England and had an outcome recorded for their first DAA treatment episode, were included. Subtypes were divided into epidemic and endemic in England; endemic subtypes were confirmed with whole genome sequencing and resistance associated substitutions (RAS) were determined. Logistic regression was used to determine associations between treatment outcome and exposure variables. RESULTS In people with an outcome recorded, 93 with an endemic and 8671 with an epidemic HCV subtype were identified, of whom 49.5% (46/93) and 91.8% (7953/8668) achieved a sustained virological response at 12 weeks post end of DAA treatment (SVR12), respectively. In the multivariable model, people with an endemic subtype had 93% (aOR 0.07 95%CI 0.04-0.12, P=<0.001) reduced odds of achieving SVR12. Treatment with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir was successful for genotypes 1, 2, 4 and 5 (SVR12 100%, n=13) but not 3 (27.3%, n=22) endemic subtypes. Sofosbuvir/velpatasvir/voxilaprevir was successful for GT3 endemic subtypes at retreatment (SVR12 11/12, 91.7%). Treatment failures for genotypes 1, 3 and 4 were likely mediated by naturally occurring baseline NS5A RAS (median n=2). DISCUSSION This study provides further evidence that endemic HCV subtypes lead to sub-optimal DAA efficacy, which may impact global HCV elimination.
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Affiliation(s)
- Laura T Phillips
- UK Health Security Agency, London, UK; National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK
| | - Daniel Bradshaw
- UK Health Security Agency, London, UK; National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK.
| | | | - Ruth Simmons
- UK Health Security Agency, London, UK; National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK
| | - William M Rosenberg
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK; UCL Institute for Liver and Digestive Health, Royal Free London, UK
| | - Caroline A Sabin
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK; Institute for Global Health, UCL, Royal Free London, UK
| | - Jean L Mbisa
- UK Health Security Agency, London, UK; National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Blood Borne and Sexually Transmitted Infections at UCL, London, UK
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18
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Pan Z, Xu L, Fan Z, Ren F. CRIPSR-Cas for hepatitis virus: a systematic review and meta-analysis of diagnostic test accuracy studies. Front Microbiol 2025; 16:1509890. [PMID: 40099180 PMCID: PMC11912011 DOI: 10.3389/fmicb.2025.1509890] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2024] [Accepted: 02/05/2025] [Indexed: 03/19/2025] Open
Abstract
Background and aims Hepatitis viruses pose a significant global health challenge, necessitating accurate and efficient diagnostic methods. The CRISPR-Cas system, renowned for gene editing, shows potential tool in virus detection. This systematic review and meta-analysis aims to evaluate the diagnostic accuracy of CRISPR-Cas-based tests for hepatitis viruses, aiming to provide evidence for their effectiveness in clinical settings. Methods Studies from Web of Science, PubMed, and CNKI were analyzed. A bivariate random-effects model was employed to compute pooled estimates for sensitivity, specificity, and the area under the summary receiver operating characteristic (SROC) curve. Additionally, the methodological quality of the studies was evaluated using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Results Following a rigorous screening process, 14 studies meeting our inclusion criteria were selected from an initial pool of 657 studies. The pooled sensitivity and specificity of the CRISPR-Cas system in hepatitis virus detection showed high sensitivity (0.99, 95% CI: 0.95-1.00) and specificity (0.99, 95% CI: 0.93-1.00) with SROC area 1.00 (95% CI: 0.99-1.00). However, considering the notable heterogeneity among the included studies, subgroup analyses and meta-regression were conducted. These analyses revealed that the type of hepatitis virus detected and the format of the final result presentation could be potential sources of this heterogeneity. Conclusion This systematic review and meta-analysis demonstrates the high diagnostic accuracy of CRISPR-Cas system in detecting hepatitis viruses. However, conclusions are limited by study number and quality. Therefore, more high-quality data are still needed to support this conclusion.
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Affiliation(s)
| | | | | | - Feng Ren
- Beijing Institute of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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19
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Scheibe A, Steingo J, Grace G, Savva H, Sonderup M, Hausler H, Spearman CW. Feasibility of implementing viral hepatitis services into a correctional service facility in Cape Town, South Africa. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2025; 137:104710. [PMID: 39855009 PMCID: PMC11892007 DOI: 10.1016/j.drugpo.2025.104710] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2024] [Revised: 01/09/2025] [Accepted: 01/11/2025] [Indexed: 01/27/2025]
Abstract
BACKGROUND Hepatitis B virus (HBV) and hepatitis C virus (HCV) are estimated to be of the most prevalent infectious diseases in correctional settings worldwide. However, viral hepatitis services have not been routinely integrated into South African correctional facilities. We aimed to assess prevalence of HBV infection and HCV infection among people accessing HIV services and assess the feasibility of viral hepatitis service integration in a South African correctional centre. METHODS Voluntarily participating people in a correctional services facility were offered free hepatitis B surface antigen (HBsAg) and anti-HCV point-of-care testing in addition to routine HIV testing and treatment services on a first-come, first-served basis during June 2021-March 2022. Off-site laboratory testing (HBV and HCV molecular testing and non-invasive liver fibrosis staging) and screening for hepatocellular carcinoma informed further management. A general practitioner at the facility managed participants, with virtual support from hepatologists. Data on age and history of injecting was collected and point-of-care and laboratory results were recorded. Data were analysed using descriptive statistics. RESULTS The median age of the 765 people who participated was 32.5 years (IQR 27.5 - 38.2), with 2.2% (17/765) reporting having ever injected a drug. The sample prevalence was 3.9% (30/765) for HBV infection, 0.5% (3/665) for HCV infection, and 1.2% (9/765) for HIV-HBV coinfection. Thirty people had reactive HBsAg point-of-care tests. Among those with reactive HBsAg point-of-care tests 90.0% (27/30) received work-up, among whom 48.1% (13/27) were monitored, 44.4% (12/27) were placed on treatment and two people were released before a management plan could be finalised. Of those treated 33.3% (4/12) started tenofovir/emtricitabine and 66.7% (8/12) antiretroviral therapy. Of the eligible participants, 27.3% (201/735) received at least one hepatitis B vaccine dose and 26.9% (54/201) received three doses. All three participants who had confirmed HCV infection were started on direct-acting antivirals. Of the two completing treatment one achieved sustained virological response at 12 weeks (SVR12), one person was released before SVR12 was done. One person was lost to follow-up. No clinical adverse events were reported. CONCLUSION There was a notable viral hepatitis burden among people in this correctional centre and integration of viral hepatitis services into the existing HIV services was acceptable and feasible. Further efforts to sustain and expand access to viral hepatitis services in South African correctional centres could catalyse national viral hepatitis elimination efforts.
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Affiliation(s)
- Andrew Scheibe
- TB HIV Care, 7th Floor, 11 Adderley Street City Centre, Cape Town 8001, South Africa; Community Oriented Primary Care Research Unit, Department of Family Medicine, University of Pretoria, 31 Bophelo Road, Gezina, Pretoria, 0084, South Africa.
| | - Joel Steingo
- TB HIV Care, 7th Floor, 11 Adderley Street City Centre, Cape Town 8001, South Africa.
| | - Gaynor Grace
- Department of Correctional Services, Goodwood Correctional Centre, Peninsula Drive, Monte Vista, 7460, South Africa.
| | - Helen Savva
- United States Centers for Disease Control and Prevention, Division of Global HIV and TB, 100 Totius St, Groenkloof, Pretoria, 0027, South Africa.
| | - Mark Sonderup
- Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Main Road, Observatory, Cape Town, South Africa.
| | - Harry Hausler
- TB HIV Care, 7th Floor, 11 Adderley Street City Centre, Cape Town 8001, South Africa; Community Oriented Primary Care Research Unit, Department of Family Medicine, University of Pretoria, 31 Bophelo Road, Gezina, Pretoria, 0084, South Africa.
| | - C Wendy Spearman
- Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Main Road, Observatory, Cape Town, South Africa.
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20
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Dore GJ. Monitoring hepatitis C elimination among people who inject drugs: A broader approach is required. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2025; 137:104712. [PMID: 39855008 DOI: 10.1016/j.drugpo.2025.104712] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2024] [Revised: 01/06/2025] [Accepted: 01/13/2025] [Indexed: 01/27/2025]
Affiliation(s)
- Gregory J Dore
- Kirby Institute, University of New South Wales, Sydney, Australia.
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21
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Nilsson SS, Demant J, Thønnings S, Weis N, Westh H, Pinholt M. Dried blood spot: A diagnostic detection method for HBV, HCV and HIV nucleic acid using a single drop of blood. Diagn Microbiol Infect Dis 2025; 111:116661. [PMID: 39706101 DOI: 10.1016/j.diagmicrobio.2024.116661] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2024] [Revised: 11/29/2024] [Accepted: 12/16/2024] [Indexed: 12/23/2024]
Abstract
The global strategy to eradicate Hepatitis B (HBV), Hepatitis C (HCV), and HIV by 2030 is critical due to their impact and challenges to healthcare systems. HCV is curable, but HBV and HIV are only suppressible, with a vaccine available solely for HBV. Innovative diagnostic methods are needed, especially for high-risk populations like people who inject drugs (PWID). This study validates a dried blood spot (DBS) nucleic acid amplification test (NAAT) using the Hologic Panther system for detecting HBV, HCV, and HIV. The method was used to screen among PWID in the Capital Region of Denmark. The DBS method demonstrated high sensitivity, with a 95 % limit of detection (LoD) of 2711 IU/mL for HBV, 525 IU/mL for HCV, and 4022 copies/mL for HIV. Screening of 83 PWID in Denmark revealed a 13 % prevalence of active HCV infection, offering significant benefits in settings where traditional venous access is difficult.
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Affiliation(s)
- Stephen Strunge Nilsson
- Department of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark; Department of Clinical Microbiology, Copenhagen University Hospital, Herlev, Denmark.
| | - Jonas Demant
- Detpartment of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark
| | - Sara Thønnings
- Department of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark
| | - Nina Weis
- Detpartment of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
| | - Henrik Westh
- Department of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
| | - Mette Pinholt
- Department of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark
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22
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Basson AA, Weil C, Marx SE, Dylla DE, Collins M, Hadadi S, Chodick G, Rahamim-Cohen D, Lavi IK, Shibolet O. Road to Hepatitis C Elimination in Israel: Improvements in Linkage to Care (2009-2020). Adv Ther 2025; 42:1522-1536. [PMID: 39912989 PMCID: PMC11868148 DOI: 10.1007/s12325-024-03102-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Accepted: 12/20/2024] [Indexed: 02/07/2025]
Abstract
INTRODUCTION Disrupted linkage to care is a major barrier to hepatitis C virus (HCV) elimination leading to high attrition rates. This study aimed to describe (1) flow through the HCV care-cascade (2009-2020), and (2) monthly patterns in HCV care during the coronavirus disease 2019 (COVID-19) pandemic (2020) in Israel. METHODS Data were obtained from Maccabi Healthcare Services, a 2.6-million-member healthcare provider in Israel. Flow through the HCV care-cascade in 2009-2020 was described from individuals' first positive HCV antibody (Ab+) test to sustained virological response (SVR), and monthly data were obtained on individuals newly attaining a given stage in the HCV care-cascade in 2020. RESULTS Among 2809 new patients who were Ab+, 2651 (94.4%) had an HCV polymerase chain reaction (PCR) test, and 1417 (50.4%) were PCR+ during the study. Median time from Ab+ to PCR+ was 3.9 years, with 39.7% PCR+ within 12 months. Median time from PCR+ to HCV treatment was 3.3 years, with 639 (55.5%) of patients who were PCR+ purchasing direct-acting anti-viral agents (DAAs), and 413/416 patients attained SVR. A significant reduction was observed in the time from first HCV detection (Ab+) to HCV confirmation (PCR+) and from PCR+ test to HCV treatment purchase in the pre-DAA era compared to the post-DAA. Monthly data during 2020 (Part B) indicates a decline in the numbers of patients receiving HCV care during the first pandemic-related closure. CONCLUSION Real-world data from a nationally representative healthcare provider database suggest that HCV linkage to care improved over time alongside increased access to DAAs, despite observed declines in access to care in 2020.
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Affiliation(s)
| | - Clara Weil
- Maccabi Healthcare Services, Tel Aviv, Israel
| | - Steven E Marx
- AbbVie Inc, North Chicago, IL, USA.
- , 26525 Riverwoods Blvd, Mettawa, IL, 60048, USA.
| | | | | | | | - Gabriel Chodick
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
- Maccabi Healthcare Services, Tel Aviv, Israel
| | | | | | - Oren Shibolet
- Liver Unit, Department of Gastroenterology, Tel Aviv Medical Center, Tel-Aviv, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
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23
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Musto F, Stracuzzi M, Cibarelli A, Coppola C, Caiazzo R, David D, Di Tonno R, Garcia ML, Valentino MS, Giacomet V. Real-Life Efficacy and Safety of Glecaprevir/Pibrentasvir Pediatric Formulation for Chronic Hepatitis C Infection in Children Aged 3 to 12 Years: A Case Series of 6 Patients. Clin Ther 2025; 47:244-247. [PMID: 39904657 DOI: 10.1016/j.clinthera.2024.12.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2024] [Revised: 11/14/2024] [Accepted: 12/20/2024] [Indexed: 02/06/2025]
Abstract
PURPOSE Glecaprevir/pibrentasvir (GLE/PIB) has been approved by the European Medicines Agency and by US Food and Drug Administration for the treatment of children and adolescents aged 3 to 12 years with chronic hepatitis C (CHC) virus infection. The aim of this study was to confirm the real-world effectiveness and safety of GLE/PIB pediatric formulations in children aged 3 to 12 years with CHC. METHODS This case series describes a pediatric population (3 to ≤12 years of age) treated with a weight-based dose of GLE/PIB pediatric formulation once daily for 8 weeks. The effectiveness end point was a sustained virologic response 12 weeks after the end of treatment. Safety was assessed on adverse events and clinical/laboratory data. FINDINGS Six patients (median age 6 years; interquartile range, 3 years) were enrolled and treated between March 2023 and December 2023. Genotype distribution was as follows: 4 of 6 genotype 1 (60%), 1 of 6 genotype 2 (20%), and 1 of 6 genotype 3 (20%). Median viral load at baseline was 541,000 IU/mL (interquartile range, 641,000 IU/mL). All (100%) patients completed treatment. Sustained virologic response (SVR) 12 weeks after the end of treatment was 100%. No virologic relapse or breakthrough was observed. No adverse events occurred. IMPLICATIONS This study confirmed the real-life effectiveness and safety profile of an 8-week treatment with GLE/PIB for CHC in children aged 3 to 12 years.
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Affiliation(s)
- Francesca Musto
- Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy.
| | - Marta Stracuzzi
- Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy
| | - Alessandro Cibarelli
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Crescenzo Coppola
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Roberta Caiazzo
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Daniela David
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Raffaella Di Tonno
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Marc Lorenzo Garcia
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Maria Sole Valentino
- Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy
| | - Vania Giacomet
- Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy
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24
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Stevens A, Lafferty L, Treloar C, Cunningham EB, Dore GJ, Grebely J, Marshall AD. Acceptability of hepatitis C testing using point-of-care testing and dried blood spot collection among people at risk of hepatitis C infection. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2025; 137:104720. [PMID: 39892268 DOI: 10.1016/j.drugpo.2025.104720] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2024] [Revised: 12/19/2024] [Accepted: 01/25/2025] [Indexed: 02/03/2025]
Abstract
BACKGROUND Hepatitis C (HCV) testing innovations such as dried blood spot (DBS) and point-of-care testing should have fewer client-related barriers than traditional diagnostic pathways, yet there is limited evidence on their acceptability among people who inject drugs. To address this gap, this study sought to evaluate the acceptability of DBS and point-of-care testing among people at risk of HCV infection and understand the circumstances in which such testing is most preferred. METHODS Participants were recruited from community sites involved in the Australian HCV Point-of-Care Testing Program. Inclusion criteria were aged ≥18 years, sufficient proficiency in the English language, history of HCV testing at least once, and informed consent. Between June and August 2023, in-depth, semi-structured interviews were conducted via telephone with clients on their perceptions and experiences of HCV DBS and point-of-care testing. Data were coded and analysed thematically with Sekhon's theoretical framework of acceptability. RESULTS Forty participants were interviewed: 18 had previously received HCV DBS testing, 8 had received HCV point-of-care testing, 8 had experience with both, and 6 had no prior experience with either test. Most participants preferred point-of-care compared to DBS and venepuncture due to the shorter time to result and some identified that this reduced anxiety while waiting for results (burden). Among participants in this study, many felt that the provision of non-judgemental care was more important than whether testing was performed by peers (ethicality). Many participants indicated a preference for assisted collection when compared to self-collected or mail testing service (self-efficacy). CONCLUSION Applying Sekhon's acceptability framework highlighted remaining service gaps to bridge client HCV testing experiences, including enhanced education on testing modalities and their results, an increased need for non-judgemental care, and the use of peer support in community settings.
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Affiliation(s)
| | - Lise Lafferty
- Centre for Social Research in Health, UNSW, Australia
| | - Carla Treloar
- Centre for Social Research in Health, UNSW, Australia
| | | | | | | | - Alison D Marshall
- The Kirby Institute, UNSW, Australia; Centre for Social Research in Health, UNSW, Australia
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25
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Cornberg M, Wedemeyer H. Early treatment of acute or recently acquired hepatitis C: An important tool on the path to HCV elimination! Hepatology 2025; 81:771-773. [PMID: 38836641 DOI: 10.1097/hep.0000000000000958] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Accepted: 05/21/2024] [Indexed: 06/06/2024]
Affiliation(s)
- Markus Cornberg
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Germany
- German Liver Foundation, Hannover, Germany
- German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Germany
- Center for Individualized Infection Medicine (CiiM), Hannover, Germany
| | - Heiner Wedemeyer
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Germany
- German Liver Foundation, Hannover, Germany
- German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Germany
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26
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Young C, Singh M, Jackson KJL, Field MA, Peters TJ, Angioletti-Uberti S, Frenkel D, Ravishankar S, Gupta M, Wang JJ, Agapiou D, Faulks ML, Al-Eryani G, Luciani F, Gordon TP, Reed JH, Danta M, Carr A, Kelleher AD, Dore GJ, Matthews G, Brink R, Bull RA, Suan D, Goodnow CC. A triad of somatic mutagenesis converges in self-reactive B cells to cause a virus-induced autoimmune disease. Immunity 2025; 58:412-430.e10. [PMID: 39818208 DOI: 10.1016/j.immuni.2024.12.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2024] [Revised: 09/22/2024] [Accepted: 12/18/2024] [Indexed: 01/18/2025]
Abstract
The unexplained association between infection and autoimmune disease is strongest for hepatitis C virus-induced cryoglobulinemic vasculitis (HCV-cryovas). To analyze its origins, we traced the evolution of pathogenic rheumatoid factor (RF) autoantibodies in four HCV-cryovas patients by deep single-cell multi-omic analysis, revealing three sources of B cell somatic mutation converged to drive the accumulation of a large disease-causing clone. A method for quantifying low-affinity binding revealed recurring antibody variable domain combinations created by V(D)J recombination that bound self-immunoglobulin G (IgG) but not viral E2 antigen. Whole-genome sequencing revealed thousands of somatic mutations, numerically comparable to chronic lymphocytic leukemia and normal memory B cells, but with 1-2 corresponding to driver mutations found recurrently in B cell leukemia and lymphoma. V(D)J hypermutation created autoantibodies with compromised solubility in complex with self-IgG. In this virus-induced autoimmune disease, infection promotes a catastrophic confluence of somatic mutagenesis in the descendants of a single B cell.
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Affiliation(s)
- Clara Young
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia
| | - Mandeep Singh
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia
| | | | - Matt A Field
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; Australian Institute of Tropical Health and Medicine and Centre for Tropical Bioinformatics and Molecular Biology, Smithfield, Cairns, QLD, Australia; Menzies School of Health Research, Darwin, NT, Australia
| | - Timothy J Peters
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia
| | | | - Daan Frenkel
- Yusuf Hamied Department of Chemistry, University of Cambridge, Cambridge, UK
| | | | - Money Gupta
- School of Biomedical Sciences, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Jing J Wang
- Department of Immunology, Flinders University and SA Pathology, Bedford Park, Adelaide, SA, Australia
| | - David Agapiou
- The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Megan L Faulks
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia
| | | | - Fabio Luciani
- School of Biomedical Sciences, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Tom P Gordon
- Department of Immunology, Flinders University and SA Pathology, Bedford Park, Adelaide, SA, Australia
| | - Joanne H Reed
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; Westmead Institute for Medical Research, Westmead, Sydney, NSW, Australia
| | - Mark Danta
- St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia
| | - Andrew Carr
- Immunology and HIV Unit, St Vincent's Hospital, Sydney, NSW, Australia
| | - Anthony D Kelleher
- The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Immunology and HIV Unit, St Vincent's Hospital, Sydney, NSW, Australia
| | - Gregory J Dore
- St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Gail Matthews
- St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Robert Brink
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia
| | - Rowena A Bull
- School of Biomedical Sciences, UNSW Sydney, Sydney, NSW, Australia; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Dan Suan
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia.
| | - Christopher C Goodnow
- Garvan Institute of Medical Research, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW Sydney, Sydney, NSW, Australia.
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27
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Uribe-Noguez LA, Prieto-Torres ME, Uribe-Noguez LO, Mata-Marín JA, Arroyo-Anduiza CI, Paquentín-Jimenez R, Chaparro-Sanchez A, Vazquez-Gonzalez WG, Santos Coy-Arechavaleta A, Pompa-Mera EN, Gaytán-Martínez J, Alvarado-Yaah JE, Santacruz-Tinoco CE, Ocaña-Mondragón A. Prevalence and Risk Factors of Occult HCV Infection in the Adult Population of Mexico City. Viruses 2025; 17:236. [PMID: 40006991 PMCID: PMC11860181 DOI: 10.3390/v17020236] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/09/2025] [Revised: 01/31/2025] [Accepted: 02/03/2025] [Indexed: 02/27/2025] Open
Abstract
Occult HCV infection (OCI) is defined by the presence of HCV RNA in hepatocytes and/or peripheral blood mononuclear cells (PBMCs) without detectable HCV RNA or anti-HCV antibodies in plasma. OCI is underrecognized and may contribute to HCV transmission. This study estimated OCI prevalence and associated risk factors in adults from Mexico City. Methods: A retrospective cross-sectional study was conducted, analyzing 507 general population volunteers. Demographic data and potential risk factors were collected via questionnaire. Anti-HCV detection was performed using two techniques: immunochromatographic rapid test and chemiluminescent microparticle immunoassay (CMIA). Nested PCR was employed to detect HCV RNA in plasma and PBMCs. Positive samples were genotyped through sequencing and phylogenetic analysis of the Core/E1 region. Results: Of 507 participants, four were anti-HCV positive. HCV RNA was found in PBMCs of 27 individuals, while plasma samples tested negative, indicating a 5.3% OCI prevalence. OCI was significantly associated with blood donation (p = 0.015), drug use (p = 0.019), particularly cocaine (p = 0.001), and endoscopy (p = 0.043). Genotypes 1b, 1a, 2b, 3a, and 2j were detected in OCI cases. Conclusions: OCI prevalence in Mexico City's general population is notable, with significant links to blood donation, cocaine use, and endoscopy. Enhanced diagnostic strategies are crucial to detect OCI and mitigate HCV transmission.
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Affiliation(s)
- Luis Antonio Uribe-Noguez
- Laboratorio Central de Epidemiología, División de Laboratorios Especializados, Centro Médico Nacional (CMN) “La Raza”, IMSS, México City 02990, Mexico; (W.G.V.-G.); (A.S.C.-A.); (J.E.A.-Y.); (A.O.-M.)
| | - María Erandhi Prieto-Torres
- Coordinación de Información y Análisis Estratégico, Instituto Mexicano del Seguro Social (IMSS), Mexico City 77503, Mexico;
| | | | - José Antonio Mata-Marín
- Departamento de Enfermedades Infecciosas, Hospital de Infectología, CMN “La Raza”, IMSS, Mexico City 02990, Mexico; (J.A.M.-M.); (A.C.-S.); (J.G.-M.)
| | | | - Rebeca Paquentín-Jimenez
- Inflammatory Eye Disease Clinic, Asociación Para Evitar la Ceguera en México, Hospital “Dr. Luis Sánchez Bulnes”, México City 04030, Mexico;
| | - Alberto Chaparro-Sanchez
- Departamento de Enfermedades Infecciosas, Hospital de Infectología, CMN “La Raza”, IMSS, Mexico City 02990, Mexico; (J.A.M.-M.); (A.C.-S.); (J.G.-M.)
| | - Wendy Guadalupe Vazquez-Gonzalez
- Laboratorio Central de Epidemiología, División de Laboratorios Especializados, Centro Médico Nacional (CMN) “La Raza”, IMSS, México City 02990, Mexico; (W.G.V.-G.); (A.S.C.-A.); (J.E.A.-Y.); (A.O.-M.)
| | - Andrea Santos Coy-Arechavaleta
- Laboratorio Central de Epidemiología, División de Laboratorios Especializados, Centro Médico Nacional (CMN) “La Raza”, IMSS, México City 02990, Mexico; (W.G.V.-G.); (A.S.C.-A.); (J.E.A.-Y.); (A.O.-M.)
| | - Ericka Nelly Pompa-Mera
- Unidad de Investigación en Enfermedades Infecciosas y Parasitarias, Hospital de Pediatría, CMN “Siglo XXI”, IMSS, Mexico City 06720, Mexico;
| | - Jesus Gaytán-Martínez
- Departamento de Enfermedades Infecciosas, Hospital de Infectología, CMN “La Raza”, IMSS, Mexico City 02990, Mexico; (J.A.M.-M.); (A.C.-S.); (J.G.-M.)
| | - Julio Elias Alvarado-Yaah
- Laboratorio Central de Epidemiología, División de Laboratorios Especializados, Centro Médico Nacional (CMN) “La Raza”, IMSS, México City 02990, Mexico; (W.G.V.-G.); (A.S.C.-A.); (J.E.A.-Y.); (A.O.-M.)
| | | | - Alicia Ocaña-Mondragón
- Laboratorio Central de Epidemiología, División de Laboratorios Especializados, Centro Médico Nacional (CMN) “La Raza”, IMSS, México City 02990, Mexico; (W.G.V.-G.); (A.S.C.-A.); (J.E.A.-Y.); (A.O.-M.)
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Gan C, Yuan Y, Shen H, Gao J, Kong X, Che Z, Guo Y, Wang H, Dong E, Xiao J. Liver diseases: epidemiology, causes, trends and predictions. Signal Transduct Target Ther 2025; 10:33. [PMID: 39904973 PMCID: PMC11794951 DOI: 10.1038/s41392-024-02072-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2024] [Revised: 10/06/2024] [Accepted: 11/12/2024] [Indexed: 02/06/2025] Open
Abstract
As a highly complex organ with digestive, endocrine, and immune-regulatory functions, the liver is pivotal in maintaining physiological homeostasis through its roles in metabolism, detoxification, and immune response. Various factors including viruses, alcohol, metabolites, toxins, and other pathogenic agents can compromise liver function, leading to acute or chronic injury that may progress to end-stage liver diseases. While sharing common features, liver diseases exhibit distinct pathophysiological, clinical, and therapeutic profiles. Currently, liver diseases contribute to approximately 2 million deaths globally each year, imposing significant economic and social burdens worldwide. However, there is no cure for many kinds of liver diseases, partly due to a lack of thorough understanding of the development of these liver diseases. Therefore, this review provides a comprehensive examination of the epidemiology and characteristics of liver diseases, covering a spectrum from acute and chronic conditions to end-stage manifestations. We also highlight the multifaceted mechanisms underlying the initiation and progression of liver diseases, spanning molecular and cellular levels to organ networks. Additionally, this review offers updates on innovative diagnostic techniques, current treatments, and potential therapeutic targets presently under clinical evaluation. Recent advances in understanding the pathogenesis of liver diseases hold critical implications and translational value for the development of novel therapeutic strategies.
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Affiliation(s)
- Can Gan
- Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China
| | - Yuan Yuan
- Aier Institute of Ophthalmology, Central South University, Changsha, China
| | - Haiyuan Shen
- Department of Oncology, the First Affiliated Hospital; The Key Laboratory of Anti-inflammatory and Immune Medicine, Ministry of Education, Anhui Medical University, Hefei, China
| | - Jinhang Gao
- Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China
| | - Xiangxin Kong
- Engineering and Translational Medicine, Medical College, Tianjin University, Tianjin, China
| | - Zhaodi Che
- Clinical Medicine Research Institute and Department of Anesthesiology, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Yangkun Guo
- Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China
| | - Hua Wang
- Department of Oncology, the First Affiliated Hospital; The Key Laboratory of Anti-inflammatory and Immune Medicine, Ministry of Education, Anhui Medical University, Hefei, China.
| | - Erdan Dong
- Research Center for Cardiopulmonary Rehabilitation, University of Health and Rehabilitation Sciences Qingdao Hospital, School of Health and Life Sciences, University of Health and Rehabilitation Sciences, Qingdao, China.
- Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, State Key Laboratory of Vascular Homeostasis and Remodeling, Peking University, Beijing, China.
| | - Jia Xiao
- Clinical Medicine Research Institute and Department of Anesthesiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
- Department of Gastroenterology, Qingdao Central Hospital, University of Health and Rehabilitation Sciences, Qingdao, China.
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Razavi HA, Waked I, Qureshi H, Kondili LA, Duberg AS, Aleman S, Tanaka J, Lazarus JV, Low-Beer D, Abbas Z, Rached AA, Aghemo A, Aho I, Akarca US, Al-Busafi SA, Al-Hamoudi WK, Al-Naamani K, Alaama AS, Aldar MM, Alghamdi M, Gonzalez MA, Alserehi H, Anand AC, Asselah T, Assiri AM, Athanasakis K, Atugonza R, Ben-Ari Z, Berg T, Brandão-Mello CE, Brown ASM, Brown KA, Brown RS, Bruggmann P, Brunetto MR, Buti M, Cheinquer H, Christensen PB, Chulanov V, Cisneros Garza LE, Coffin CS, Coppola N, Craxi A, Crespo J, Cui F, Dalgard O, De La Torre A, De Ledinghen V, Dieterich D, Drazilova S, Dufour JF, El-Kassas M, Elbadri M, Esmat G, Mur RE, Eurich B, Faini D, Ferreira PRA, Flisiak R, Frankova S, Gaeta GB, Gamkrelidze I, Gane EJ, Garcia V, García-Samaniego J, Gemilyan M, Gottfredsson M, Gschwantler M, Gurski APM, Hajarizadeh B, Hamid SS, Hatzakis A, Hercun J, Hockicková I, Huang JF, Hunyady B, Hutchinson SJ, Ishikawa N, Izumi K, Izzi A, Janicko M, Jarcuska P, Jeruma A, Johannessen A, Kaliaskarova KS, Kao JH, Kielland KB, Kodjoh N, Kottilil S, Kristian P, Kwo PY, Lagging M, Lam H, Lázaro P, Lee MH, Lens S, Liakina V, Lim YS, Makara M, Manns M, Manzengo CM, Memon S, Mendes-Correa MC, Messina V, Midgard H, Murphy N, Musabaev E, Naveira MCM, Nde H, Negro F, Nim N, Ocama P, Olafsson S, Omuemu CE, Pamplona JJ, Pan CQ, Papatheodoridis GV, Pimenov N, Poustchi H, Quaranta MG, Ramji A, Rautiainen H, Razavi-Shearer DM, Razavi-Shearer K, Ridruejo E, Ríos-Hincapié CY, Sadirova S, Sanai FM, Sarrazin C, Sarybayeva G, Schréter I, Seguin-Devaux C, Sereno LS, Shiha G, Smith J, Soliman R, Sonderup MW, Spearman CW, Stauber RE, Stedman CAM, Sypsa V, Tacke F, Terrault NA, Tolmane I, Van Welzen B, Voeller AS, Waheed Y, Wallace C, Whittaker RN, W-S Wong V, Ydreborg M, Yesmembetov K, Yu ML, Zeuzem S, Zuckerman E. Number of people treated for hepatitis C virus infection in 2014-2023 and applicable lessons for new HBV and HDV therapies. J Hepatol 2025:S0168-8278(25)00020-0. [PMID: 39914746 DOI: 10.1016/j.jhep.2025.01.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Revised: 01/09/2025] [Accepted: 01/10/2025] [Indexed: 03/20/2025]
Abstract
BACKGROUND AND AIMS The year 2023 marked the 10-year anniversary of the launch of direct-acting antivirals (DAAs) for the treatment of the hepatitis C virus (HCV). HCV treatment trends by country, region, and globally are important to monitor progress toward the World Health Organization's 2030 elimination targets. Additionally, the historical patterns can help predict the treatment uptake for future therapies for other liver diseases. METHODS The number of people living with HCV (PLHCV) treated between 2014-2023 across 119 countries was estimated using national HCV registries, reported DAA sales data, pharmaceutical companies' reports, and estimates provided by national experts. For the countries with no available data, the average estimate of the corresponding Global Burden of Disease region was used. RESULTS An estimated 13,816,000 (95% uncertainty intervals (UI): 13,221,000-16,415,000) PLHCV were treated, of whom 12,748,000 (12,226,000-15,231,000) were treated with DAAs, of which 11,081,000 (10,542,000-13,338,000) were sofosbuvir-based DAA regimens. Country-level data accounted for 97% of these estimates. In high-income countries, there was a 41% drop in treatment from its peak, and reimbursement was a large predictor of treatment. In low- and middle-income countries, price played an important role in expanding treatment access through the public and private markets, and treatment continues to increase slowly after a sharp drop at the end of the Egyptian national program. CONCLUSIONS In the last 10 years, 21% of all HCV infections were treated with DAAs. Regional and temporal variations highlight the importance of active screening strategies. Without program enhancements, the number of treated PLHCV stalled in every country/region which may not reflect a lower prevalence but may instead reflect the diminishing returns of the existing strategies. IMPACT AND IMPLICATIONS Long-term hepatitis C virus (HCV) infection can lead to cirrhosis and liver cancer. Since 2014, these infections can be effectively treated with 8-12 weeks of oral therapies. In 2015, the World Health Organization (WHO) established targets to eliminate HCV by 2030, which included treatment targets for member countries. The current study examines HCV treatment patterns across 119 countries and regions from 2014 to 2023 to assess the impact of national programs. This study can assist physicians and policymakers in understanding treatment patterns within similar regions or income groups and in utilizing historical data to refine their strategies in the future.
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Affiliation(s)
- Homie A Razavi
- Center for Disease Analysis Foundation, Lafayette, United States.
| | - Imam Waked
- Hepatology, National Liver Institute, Shebeen El Kom, Egypt
| | - Huma Qureshi
- Gastroenterologist, Focal Point Hepatitis, Ministry of National Health Services, Regulations and Coordination, Islamabad, Pakistan
| | - Loreta A Kondili
- National Center for Global Health, Istituto Superiore di Sanita, Rome, Italy; UniCamillus-Saint Camillus International University of Health Sciences, Rome, Italy
| | - Ann-Sofi Duberg
- Department of Infectious Diseases, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
| | - Soo Aleman
- Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
| | - Junko Tanaka
- Epidemiology, Infectious Disease Control and Prevention, Hiroshima University, Hiroshima, Japan
| | - Jeffrey V Lazarus
- CUNY Graduate School of Public Health and Health Policy, New York City, United States; Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain
| | - Daniel Low-Beer
- Global Hepatitis Programme, World Health Organization, Geneva, Switzerland
| | - Zaigham Abbas
- Hepatogastroenterology, Dr. Ziauddin University Hospital, Karachi, Pakistan
| | - Antoine Abou Rached
- Internal Medicine - Gastroenterology, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon
| | - Alessio Aghemo
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Department of Gastroenterology, Humanitas Research Hospital IRCCS, Rozzano, Italy
| | - Inka Aho
- Infectious Diseases, Helsinki University Hospital, Helsinki, Finland
| | - Ulus S Akarca
- Department of Gastroenterology, Ege University, Medical School, Izmir, Turkey
| | - Said A Al-Busafi
- Medicine, College of Medicine and Health Sciences, Sultan Qaboos University, AlKhoudh, Oman
| | | | - Khalid Al-Naamani
- Internal Medicine, Division of Gastroenterology and Hepatology, Armed Forces Hospital, Muscat, Oman
| | - Ahmed Sabry Alaama
- World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt
| | - Manahil M Aldar
- Viral Hepatitis Control Program, Ministry of Health, Ryiadh, Saudi Arabia
| | - Mohammed Alghamdi
- Gastroenterology Unit, Department of Medicine, King Fahad Military Medical Complex, Dhahran, Saudi Arabia
| | | | | | - Anil C Anand
- Gastroenterology & Hepatology, Kalinga Institute of Medical Sciences, Bhubaneswar, India
| | - Tarik Asselah
- Hepatology Department, Université de Paris-Cité, Hôpital Beaujon, AP-HP, INSERM UMR, Paris, France
| | | | - Kostas Athanasakis
- Department of Public Health Policy, University of West Attica, Athens, Greece
| | | | - Ziv Ben-Ari
- Liver Medicine Center of Excellence, Assuta medical Centers, Tel Aviv, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Thomas Berg
- Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany
| | - Carlos E Brandão-Mello
- Internal Medicine & Gastroenterology, University of Rio de Janeiro, Rio de Janeiro, Brazil; Clinica de Doenças do Fígado, Rio de Janeiro, Brazil
| | - Ashley S M Brown
- Department of Hepatology, Imperial College Healthcare NHS Trust, London, United Kingdom
| | - Kimberly A Brown
- Department of Medicine, Henry Ford Hospital, Detroit, United States
| | - Robert S Brown
- Medicine, Weill Cornell Medicine, New York, United States
| | | | - Maurizia R Brunetto
- Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; Hepatology Unit, University Hospital of Pisa, Pisa, Italy
| | - Maria Buti
- Liver Unit, Hospital Universitari Vall d Hebron and CIBEREHD del Insituto Carlos III. Universidad Autonoma de Barcelona, Barcelona, Spain
| | - Hugo Cheinquer
- Department of Gastroenterology and Hepatology, Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, Brazil
| | - Peer Brehm Christensen
- Department of Infectious Diseases, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Vladimir Chulanov
- National Medical Research Center of Phthisiopulmonology & Infectious Diseases, Moscow, Russia; Department of Infectious Diseases, I.M. Sechenov First Moscow State Medical University, Sechenov University, Moscow, Russia
| | - Laura E Cisneros Garza
- Department of Hepatology, Hospital Christus Muguerza Alta Especialidad, Monterrey, Mexico
| | - Carla S Coffin
- Medicine / Microbiology and Infectious Diseases Department, Cumming School of Medicine, University of Calgary, Calgary, Canada
| | - Nicola Coppola
- Mental health and Public medicine, University of Campania, Naples, Italy
| | - Antonio Craxi
- PROMISE, School of Medicine, University of Palermo, Palermo, Italy
| | - Javier Crespo
- Gastroenterology and Hepatology Department, Clinical and Translational Research in Digestive Diseases, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain; School of Medicine, University of Cantabria, Santander, Spain
| | - Fuqiang Cui
- School of Public Health, Peking University, Beijing, China's Mainland
| | - Olav Dalgard
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
| | | | - Victor De Ledinghen
- Service d'hepatologie et de transplantation hepatique, CHU, Bordeaux, France
| | - Douglas Dieterich
- Institute for Liver Medicine, Icahn School of Medicine at Mount Sinai, New York, United States
| | - Sylvia Drazilova
- 2nd Dept of Internal Medicine, PJ Safarik University, Faculty of Medicine and L Pasteur University Hospital, Kosice, Slovakia
| | | | | | - Mohammed Elbadri
- Gastroenterology Department, Hamad Medical Corporation, Doha, Qatar
| | - Gamal Esmat
- Endemic medicine department, Cairo University Hospitals, Cairo, Egypt
| | - Rafael Esteban Mur
- Department of Hepatology, Hospital Universitario Vall d'Hebron, Barcelona, Spain
| | - Brandon Eurich
- Center for Disease Analysis Foundation, Lafayette, United States
| | - Diana Faini
- Global Hepatitis Programme, WHO, Geneva, Switzerland
| | - Paulo R A Ferreira
- Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland
| | - Sona Frankova
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czechia
| | | | | | - Edward J Gane
- New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand
| | - Virginia Garcia
- Gastroenterology Professor at Universidad Autonoma de Santo Domingo / Doctor at Centro Endoscopico Digestivo Integral / Retire doctor from the Health Ministry in the Dominican Republic, Santo Domingo, Dominican Republic
| | - Javier García-Samaniego
- Liver Unit, Hospital Universitario La Paz, CIBERehd/IdiPAZ. Universidad Autónoma de Madrid, Madrid, Spain
| | - Manik Gemilyan
- Department of Gastroenterology and Hepatology, Yerevan State Medical University, Yerevan, Armenia
| | - Magnus Gottfredsson
- Departments of science and infectious diseases, Landspitali University Hospital, Reykjavík, Iceland; Faculty of Medicine, University of Iceland, Reykjavík, Iceland
| | - Michael Gschwantler
- Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria; Sigmund Freud University, Vienna, Austria
| | - Ana P M Gurski
- Department of HIV/Aids, Tuberculosis, Viral Hepatitis and Sexually Transmitted Infections, Ministry of Health, Brasilia, Brazil
| | | | | | - Angelos Hatzakis
- Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Julian Hercun
- Liver Unit, Centre hospitalier de l'Universite de Montreal, Montreal, Canada
| | - Ivana Hockicková
- Department of Infectology and Travel Medicine, P.J. Safarik University, Faculty of Medicine and L. Pasteur University Hospital, Kosice, Slovakia
| | - Jee-Fu Huang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Bela Hunyady
- Division of Gastroenterology, First Department of Medicine, Clinical Centre, University of Pecs, Budapest, Hungary
| | - Sharon J Hutchinson
- School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, United Kingdom; Clinical and Protecting Health Directorate, Public Health Scotland, Glasgow, United Kingdom
| | - Naoko Ishikawa
- Global Hepatitis Programme, World Health Organization, Geneva, Switzerland
| | - Kiyohiko Izumi
- Division of Programmes for Disease Control, World Health Organization Regional Office for the Western Pacific, Manila, Philippines
| | - Antonio Izzi
- Department of Infectious Diseases and Emergency Infectious Disease, Division of Highly Contagious Infections Diseases, "D. Cotugno" hospital, Naples, Italy
| | - Martin Janicko
- 2nd Dept of Internal Medicine, PJ Safarik University, Faculty of Medicine and L Pasteur University Hospital, Kosice, Slovakia
| | - Peter Jarcuska
- 2nd Dept of Internal Medicine, PJ Safarik University, Faculty of Medicine and L Pasteur University Hospital, Kosice, Slovakia
| | - Agita Jeruma
- Riga East University hospital, Riga, Latvia; Faculty of Medicine, Riga Stradins University, Riga, Latvia
| | | | | | - Jia-Horng Kao
- Hepatitis Research Center , National Taiwan University Hospital, Taipei, Taiwan
| | - Knut B Kielland
- Research Center for Substance Use Disorders and Mental Illness, Innlandet Hospital Trust, Brumunddal, Norway
| | - Nicolas Kodjoh
- Faculté des Sciences de la Santé, Université d'Abomey Calavi, Cotonou, Benin
| | - Shyamasundaran Kottilil
- Institute of Human Virology, University of Maryland School of Medicine, Baltimore, United States
| | - Pavol Kristian
- Department of Infectology and Travel Medicine, P.J. Safarik University, Faculty of Medicine and L. Pasteur University Hospital, Kosice, Slovakia
| | - Paul Y Kwo
- Medicine, Stanford University School of Medicine, Redwood City, United States
| | - Martin Lagging
- Department of Infectious Diseases / Virology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Clinical Microbiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden
| | - Hilton Lam
- Institute of Health Policy and Development Studies, University of the Philippines, Manila, Philippines
| | - Pablo Lázaro
- Independent Health Services Researcher, Madrid, Spain
| | - Mei-Hsuan Lee
- Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan
| | - Sabela Lens
- Liver Unit, Hospital Clinic, IDIBAPS, University of Barcelona, CIBERehd, Barcelona, Spain
| | - Valentina Liakina
- Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Vilnius University, Faculty of Medicine, Vilnius, Lithuania; Department of Chemistry and Bioengineering, VILNIUS TECH, Faculty of Fundamental Sciences, Vilnius, Lithuania
| | - Young-Suk Lim
- Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of
| | - Michael Makara
- Central Hospital of Southern Pest, National Institute of Hematology and Infectious Diseases, Budapest, Hungary
| | - Michael Manns
- Dept. of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
| | | | - Sadik Memon
- Gastroenterology, Asian Institute of Medical Sciences (AIMS), Hyderabad, Pakistan
| | - Maria Cássia Mendes-Correa
- Department of Infectious Diseases, School of Medicine, University of São Paulo, São Paulo, SP, Br, Sao Paulo, Brazil
| | - Vincenzo Messina
- Department of Infectious Diseases and Viral Hepatitis, Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta, Caserta, Italy
| | - Håvard Midgard
- Department of Gastroenterology, Oslo University Hospital, Oslo, Norway
| | - Niamh Murphy
- HSE, Health Protection Surveillance Centre, Dublin, Ireland
| | - Erkin Musabaev
- Virology, Research Institute of Virology, Tashkent, Uzbekistan
| | - Marcelo C M Naveira
- Communicable Diseases, Environment and Health, World Health Organization Regional Office for Europe, Copenhagen, Denmark
| | - Helen Nde
- Center for Disease Analysis Foundation, Lafayette, United States
| | | | | | | | - Sigurdur Olafsson
- Department of Gastroenterology and Hepatology, Landspitali - National University Hospital of Iceland, Reykjavik, Iceland
| | - Casimir E Omuemu
- Department of Medicine, University of Benin, Benin City, Nigeria
| | | | - Calvin Q Pan
- Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Health, NYU Grossman School of Medicine, New York, United States
| | - George V Papatheodoridis
- First Department of Gastroenterology, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Nikolay Pimenov
- National Medical Research Center of Phthisiopulmonology & Infectious Diseases, Moscow, Russia; Martsinovsky Institute of Medical Parasitology, Tropical and Vector-Borne Diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
| | - Hossein Poustchi
- Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
| | | | - Alnoor Ramji
- Department of Medicine, University of British Columbia, Vancouver, Canada
| | - Henna Rautiainen
- Specialist in Gastroenterology and Internal Medicine, Helsinki University Hospital Abdominal Center, Helsinki, Finland
| | | | | | - Ezequiel Ridruejo
- Hepatology Section, Department of Medicine., Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC"., Ciudad Autónoma de Buenos Aires, Argentina
| | - Cielo Y Ríos-Hincapié
- Dirección de Promoción y Prevención, Ministerio de Salud y Protección Social, Bogotá, Colombia
| | - Shakhlo Sadirova
- The Research institute of Virology of the Republican specialized scientific practical medical center of epidemiology, microbiology, infections and parasitics diseases, Tashkent, Uzbekistan
| | - Faisal M Sanai
- Gastroenterology, King Abdulaziz Medical City, Jeddah, Saudi Arabia
| | - Christoph Sarrazin
- Medizinische Klinik 2, St. Josefs-Hospital, Wiesbaden, Germany; Medizinische Klinik 1, Goethe-University, Frankfurt am Main, Germany
| | - Gulya Sarybayeva
- Department of Science and International Cooperation, Kazakh Science Center of Dermatology and Infectious Diseases, Almaty, Kazakhstan
| | - Ivan Schréter
- Department of Infectology and Travel Medicine, Medical Faculty, PJ Safárik University, Kosice, Slovakia
| | - Carole Seguin-Devaux
- Department of Infection and Immunity, Luxembourg Institute of Health, Esch sur Alzette, Luxembourg
| | | | - Gamal Shiha
- Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt; Egyptian Liver Research Institute and Hospital, , Mansoura, Egypt
| | - Josie Smith
- Communicable Disease Surveillance Centre, Health Protection, Public Health Wales, Cardiff, United Kingdom
| | - Riham Soliman
- Gastroenterology and Hepatology, Port Said University, Port Said, Egypt and Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
| | - Mark W Sonderup
- Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
| | - C Wendy Spearman
- Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
| | - Rudolf E Stauber
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria
| | - Catherine A M Stedman
- Department of Medicine, University of OtagoChristchurch, New Zealand; Gastroenterology, Christchurch Hospital, Christchurch, New Zealand
| | - Vana Sypsa
- Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Frank Tacke
- Department of Hepatology & Gastroenterology, Charité Universitätsmedizin Berlin, Berlin, Germany
| | - Norah A Terrault
- Keck Medicine of University of Southern California, Los Angeles, United States
| | - Ieva Tolmane
- Hepatology Department, Riga East University Hospital, Latvian Center of Infectious Diseases, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia
| | - Berend Van Welzen
- Internal Medicine & Infectious Diseases, University Medical Center Utrecht, Utrecht, Netherlands
| | - Alexis S Voeller
- Center for Disease Analysis Foundation, Lafayette, United States
| | - Yasir Waheed
- NUST School of Health Sciences, National University of Sciences and Technology (NUST), H-12, Islamabad, Pakistan; Advanced Research Centre, European University of Lefke, Lefke, Northern Cyprus, TR-10 Mersin, Turkey
| | - Carolyn Wallace
- Center for Disease Analysis Foundation, Lafayette, United States
| | - Robert N Whittaker
- Infection Control and Vaccines, Norwegian Institute of Public Health, Oslo, Norway
| | - Vincent W-S Wong
- Medical Data Analytics Centre (MDAC), Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China; State Key Laboratory of Digestive Disease, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China
| | - Magdalena Ydreborg
- Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Kakharman Yesmembetov
- Gastroenterology and hepatology, NROC, Astana, Kazakhstan; Department of medicine III, RWTH University hospital Aachen, Aachen, Germany
| | - Ming-Lung Yu
- School of Medicine, College of Medicine and Center of Excellence for Metabolic Associated Fatty Liver Disease, National Sun Yat-sen University, Kaohsiung, Taiwan; Hepatobiliary Section, Department of Internal Medicine, and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine and Hepatitis Research Center, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Stefan Zeuzem
- Goethe-University, Department of Medicine, University Hospital, Frankfurt, Germany
| | - Eli Zuckerman
- Liver Unit, Carmel Medical Center, Faculty of Medicine, Technion Institute of Technology, Haifa, Israel
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30
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Wang S, Huang C, Chang T, Lo C, Hung C, Huang C, Chong L, Cheng P, Yeh M, Peng C, Cheng C, Huang J, Bair M, Lin C, Yang C, Kuo H, Hsieh T, Lee T, Lee P, Wu W, Lin C, Su W, Yang S, Wang C, Hu J, Mo L, Chen C, Huang Y, Chang C, Huang C, Chen G, Kao C, Tai C, Liu C, Lee M, Tsai P, Dai C, Kao J, Lin H, Chuang W, Tseng K, Chen C, Wang S, Yu M. Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan. Kaohsiung J Med Sci 2025; 41:e12929. [PMID: 39829106 PMCID: PMC11827544 DOI: 10.1002/kjm2.12929] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2024] [Revised: 12/06/2024] [Accepted: 12/13/2024] [Indexed: 01/22/2025] Open
Abstract
An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-naïve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-naïve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m2) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m2). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m2. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-naïve CHC patients with both early CKD and pre-ESRD.
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Affiliation(s)
- Szu‐Jen Wang
- Graduate Institute of Clinical MedicineKaohsiung Medical UniversityKaohsiungTaiwan
- Division of Hepatogastroenterology, Department of Internal MedicineShin Huey Shin HospitalKaohsiungTaiwan
- Division of Gastroenterology, Department of Internal MedicineYuan's General HospitalKaohsiungTaiwan
| | - Chung‐Feng Huang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Ph.D. Program in Translational Medicine, College of MedicineKaohsiung Medical University, Academia SinicaKaohsiungTaiwan
| | - Te‐Sheng Chang
- Division of Hepatogastroenterology, Department of Internal MedicineChiaYi Chang Gung Memorial HospitalChiayiTaiwan
- College of MedicineChang Gung UniversityTaoyuanTaiwan
| | - Ching‐Chu Lo
- Division of Gastroenterology, Department of Internal MedicineSt. Martin De Porres HospitalChiayiTaiwan
| | - Chao‐Hung Hung
- Division of Hepatogastroenterology, Department of Internal MedicineKaohsiung Chang Gung Memorial HospitalKaohsiungTaiwan
| | - Chien‐Wei Huang
- Division of GastroenterologyKaohsiung Armed Forces General HospitalKaohsiungTaiwan
| | - Lee‐Won Chong
- Division of Hepatology and Gastroenterology, Department of Internal MedicineShin Kong Wu Ho‐Su Memorial HospitalTaipeiTaiwan
- School of MedicineFu‐Jen Catholic UniversityNew Taipei CityTaiwan
| | - Pin‐Nan Cheng
- Division of Gastroenterology and Hepatology, Department of Internal MedicineNational Cheng Kung University Hospital, College of Medicine, National Cheng Kung UniversityTainanTaiwan
| | - Ming‐Lun Yeh
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Hepatitis Research Center, College of Medicine; Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiungTaiwan
| | - Cheng‐Yuan Peng
- Centers for Digestive Medicine, Department of Internal MedicineChina Medical University HospitalTaichungTaiwan
- School of MedicineChina Medical UniversityTaichungTaiwan
| | - Chien‐Yu Cheng
- Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General HospitalMinistry of Health and WelfareTaoyuanTaiwan
| | - Jee‐Fu Huang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Hepatitis Research Center, College of Medicine; Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiungTaiwan
- School of Medicine and Doctoral Program of Clinical and Experimental Medicine, College of Medicine and Center of Excellence for Metabolic Associated Fatty Liver DiseaseNational Sun Yat‐sen UniversityKaohsiungTaiwan
| | - Ming‐Jong Bair
- Division of Gastroenterology, Department of Internal MedicineTaitung Mackay Memorial HospitalTaitungTaiwan
- Mackay Medical CollegeNew Taipei CityTaiwan
| | - Chih‐Lang Lin
- Liver Research Unit, Department of Hepato Gastroenterology and Community Medicine Research Center, Chang Gung Memorial Hospital at Keelung, College of MedicineChang Gung UniversityKeelungTaiwan
| | - Chi‐Chieh Yang
- Department of Gastroenterology, Division of Internal MedicineShow Chwan Memorial HospitalChanghuaTaiwan
| | - Hsing‐Tao Kuo
- Division of Gastroenterology and Hepatology, Department of Internal MedicineChi Mei Medical CenterYongkang DistrictTainanTaiwan
| | - Tsai‐Yuan Hsieh
- Division of Gastroenterology, Department of Internal MedicineTri Service General Hospital, National Defense Medical CenterTaipeiTaiwan
| | - Tzong‐Hsi Lee
- Division of Gastroenterology and HepatologyFar Eastern Memorial HospitalNew Taipei CityTaiwan
| | - Pei‐Lun Lee
- Division of Gastroenterology and Hepatology, Department of Internal MedicineChi Mei Medical CenterTainanTaiwan
| | | | - Chih‐Lin Lin
- Department of Gastroenterology, Renai BranchTaipei City HospitalTaipeiTaiwan
| | - Wei‐Wen Su
- Department of Gastroenterology and HepatologyChanghua Christian HospitalChanghuaTaiwan
| | - Sheng‐Shun Yang
- Division of Gastroenterology and Hepatology, Department of Internal MedicineTaichung Veterans General HospitalTaichungTaiwan
| | - Chia‐Chi Wang
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of MedicineTzu Chi UniversityTaipeiTaiwan
| | - Jui‐Ting Hu
- Liver CenterCathay General HospitalTaipeiTaiwan
| | - Lein‐Ray Mo
- Division of GastroenterologyTainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)TainanTaiwan
| | - Chun‐Ting Chen
- Division of Gastroenterology, Department of Internal MedicineTri Service General Hospital, National Defense Medical CenterTaipeiTaiwan
- Division of Gastroenterology, Department of Internal Medicine Tri Service General Hospital Penghu BranchNational Defense Medical CenterTaipeiTaiwan
| | - Yi‐Hsiang Huang
- Division of Gastroenterology and Hepatology, Department of MedicineTaipei Veterans General HospitalTaipeiTaiwan
- Institute of Clinical Medicine, School of MedicineNational Yang‐Ming Chiao Tung UniversityTaipeiTaiwan
| | - Chun‐Chao Chang
- Division of Gastroenterology and Hepatology, Department of Internal MedicineTaipei Medical University HospitalTaipeiTaiwan
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of MedicineTaipei Medical UniversityTaipeiTaiwan
| | | | | | - Chien‐Neng Kao
- National Taiwan University Hospital Hsin‐Chu BranchHsinchuTaiwan
| | - Chi‐Ming Tai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, E‐Da HospitalI‐Shou UniversityKaohsiungTaiwan
- School of Medicine for International Students, College of MedicineI‐Shou UniversityKaohsiungTaiwan
| | - Chun‐Jen Liu
- Hepatitis Research Center and Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
| | - Mei‐Hsuan Lee
- Institute of Clinical MedicineNational Yang‐Ming Chiao Tung UniversityTaipeiTaiwan
| | - Pei‐Chien Tsai
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Hepatitis Research Center, College of Medicine; Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiungTaiwan
| | - Chia‐Yen Dai
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Hepatitis Research Center, College of Medicine; Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiungTaiwan
| | - Jia‐Horng Kao
- Hepatitis Research Center and Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
| | - Han‐Chieh Lin
- Division of Gastroenterology and Hepatology, Department of MedicineTaipei Veterans General HospitalTaipeiTaiwan
- Institute of Clinical Medicine, School of MedicineNational Yang‐Ming Chiao Tung UniversityTaipeiTaiwan
| | - Wang‐Long Chuang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
| | - Kuo‐Chih Tseng
- School of MedicineTzuchi UniversityHualienTaiwan
- Department of Internal Medicine, Dalin Tzu Chi HospitalBuddhist Tzu Chi Medical FoundationChiayiTaiwan
| | - Chi‐Yi Chen
- Division of Gastroenterology and Hepatology, Department of MedicineDitmanson Medical Foundation Chiayi Christian HospitalChiayiTaiwan
| | - Shu‐Chi Wang
- Department of Medical Laboratory Science and BiotechnologyKaohsiung Medical UniversityKaohsiungTaiwan
| | - Ming‐Lung Yu
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis CenterKaohsiung Medical University Hospital, Kaohsiung Medical UniversityKaohsiungTaiwan
- Hepatitis Research Center, College of Medicine; Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiungTaiwan
- School of Medicine and Doctoral Program of Clinical and Experimental Medicine, College of Medicine and Center of Excellence for Metabolic Associated Fatty Liver DiseaseNational Sun Yat‐sen UniversityKaohsiungTaiwan
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31
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Semmler G, Alonso López S, Pons M, Lens S, Dajti E, Griemsmann M, Zanetto A, Burghart L, Hametner-Schreil S, Hartl L, Manzano M, Rodriguez-Tajes S, Zanaga P, Schwarz M, Gutierrez ML, Jachs M, Pocurull A, Polo B, Ecker D, Mateos B, Izquierdo S, Real Y, Balcar L, Carbonell-Asins JA, Gschwantler M, Russo FP, Azzaroli F, Maasoumy B, Reiberger T, Forns X, Genesca J, Bañares R, Mandorfer M. Long-term outcome and risk stratification in compensated advanced chronic liver disease after HCV-cure. Hepatology 2025; 81:609-624. [PMID: 39817915 DOI: 10.1097/hep.0000000000001005] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2023] [Accepted: 05/30/2024] [Indexed: 01/18/2025]
Abstract
BACKGROUND AND AIMS Around 750,000 patients per year will be cured of HCV infection until 2030. Those with compensated advanced chronic liver disease remain at risk for hepatic decompensation and de novo HCC. Algorithms have been developed to stratify risk early after cure; however, data on long-term outcomes and the prognostic utility of these risk stratification algorithms at later time points are lacking. APPROACH AND RESULTS We retrospectively analyzed a cohort of 2335 patients with compensated advanced chronic liver disease (liver stiffness measurement≥10 kPa) who achieved HCV-cure by interferon-free therapies from 15 European centers (median age 60.2±11.9 y, 21.1% obesity, 21.2% diabetes).During a median follow-up of 6 years, first hepatic decompensation occurred in 84 patients (3.6%, incidence rate: 0.74%/y, cumulative incidence at 6 y: 3.2%); 183 (7.8%) patients developed de novo HCC (incidence rate: 1.60%/y, cumulative incidence at 6 y: 8.3%), with both risks being strictly linear over time.Baveno VII criteria to exclude (FU-liver stiffness measurement <12 kPa and follow-up platelet count >150 g/L) or rule-in (FU-liver stiffness measurement ≥25 kPa) clinically significant portal hypertension (CSPH) stratified the risk of hepatic decompensation with proportional hazards. Estimated probability of CSPH discriminated patients developing versus not developing hepatic decompensation in the gray zone (ie, patients meeting none of the above criteria).Published HCC risk stratification algorithms identified high-incidence and low-incidence groups; however, the size of the latter group varied substantially (9.9%-69.1%). A granular "HCC-sustained virologic response" model was developed to inform an individual patient's HCC risk after HCV-cure. CONCLUSIONS In patients with compensated advanced chronic liver disease, the risks of hepatic decompensation and HCC remain constant after HCV-cure, even in the long term (>3 y). One-time post-treatment risk stratification based on noninvasive criteria provides important prognostic information that is maintained during long-term follow-up, as the hazards remain proportional over time.
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Affiliation(s)
- Georg Semmler
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
| | - Sonia Alonso López
- Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain
- Instituto De Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
- Universidad Complutense de Madrid, Madrid, Spain
| | - Monica Pons
- Liver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institut of Research (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - Sabela Lens
- Liver Unit, Hospital Clínic, IDIBAPS-FCRB, Universitat de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Elton Dajti
- Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Bologna, Italy
| | - Marie Griemsmann
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany
| | - Alberto Zanetto
- Gastroenterology and Multivisceral Transplant Unit, Department of Surgery, Oncology, and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Lukas Burghart
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria
| | | | - Lukas Hartl
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
| | - Marisa Manzano
- Liver Unit, Hospital Universitario 12 De Octubre, Madrid, Spain
| | - Sergio Rodriguez-Tajes
- Liver Unit, Hospital Clínic, IDIBAPS-FCRB, Universitat de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Paola Zanaga
- Gastroenterology and Multivisceral Transplant Unit, Department of Surgery, Oncology, and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Michael Schwarz
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria
| | - María L Gutierrez
- Gastroenterology Unit, Hospital Universitario Fundación Alcorcón, Madrid, Spain
| | - Mathias Jachs
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
| | - Anna Pocurull
- Liver Unit, Hospital Clínic, IDIBAPS-FCRB, Universitat de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Benjamín Polo
- Gastroenterology Unit, Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain
| | - Dominik Ecker
- Department of Internal Medicine IV, Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria
| | - Beatriz Mateos
- Liver Unit, Hospital Universitario Ramón y Cajal, Madrid, Spain
| | - Sonia Izquierdo
- Gastroenterology Unit, Hospital Universitario Clínico San Carlos, Madrid, Spain
| | - Yolanda Real
- Gastroenterology Unit, Hospital Universitario La Princesa, Madrid, Spain
| | - Lorenz Balcar
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
| | | | | | - Francesco P Russo
- Gastroenterology and Multivisceral Transplant Unit, Department of Surgery, Oncology, and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Francesco Azzaroli
- Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Bologna, Italy
| | - Benjamin Maasoumy
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany
| | - Thomas Reiberger
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
| | - Xavier Forns
- Liver Unit, Hospital Clínic, IDIBAPS-FCRB, Universitat de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Joan Genesca
- Liver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institut of Research (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Rafael Bañares
- Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain
- Instituto De Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
- Universidad Complutense de Madrid, Madrid, Spain
| | - Mattias Mandorfer
- Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
- Vienna Hepatic Hemodynamic Lab, Department of Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
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32
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Ferrarese A, Zanaga P, Battistella S, Zanella S, Zappitelli T, Boldrin C, Pacenti M, Cattai M, Bordignon G, Gomiero F, Epifani M, Villano M, Gambato M, Zanetto A, Cazzagon N, Chemello L, Pasin F, Calò L, Doria A, Trentin L, Illiceto S, Avogaro A, Venturini F, Simioni P, Angeli P, Tessarin M, Burra P, Cattelan A, Russo FP. In-Hospital Screening Campaign Against Hepatitis C Could Be Effective for Identifying More Patients Who Still Need Treatment. Aliment Pharmacol Ther 2025; 61:667-674. [PMID: 39655800 DOI: 10.1111/apt.18433] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2024] [Revised: 07/17/2024] [Accepted: 11/26/2024] [Indexed: 01/04/2025]
Abstract
BACKGROUND Screening programmes for the detection of patients with hepatitis C virus (HCV) and positive viral load have been developed in many countries to achieve the World Health Organization's goal of HCV elimination by 2030. In Italy, a phased screening programme starting with individuals born between 1969 and 1989 has been implemented. AIM To assess the prevalence of patients with positive viraemia identified through a universal screening campaign conducted among hospitalised patients at our centre during the calendar year 2022. METHODS All adult (aged ≥ 18 years) hospitalised patients, who participated in HCV screening from January to December 2022 were included, without any age restriction. Screening initially involved testing for anti-HCV antibodies and then patients who tested positive underwent further HCV-RNA testing. RESULTS A total of 10,846 samples were collected. Five hundred and thirty cases (4.8%) tested positive for HCV antibodies, and 109 (1%) tested positive for both HCV antibodies and HCV-RNA. Among patients with a positive viral load, the median [IQR] age was 62 [53-77] years, with a significant age difference between males and females (59 [48-67] vs. 78 [62-88]; Mann-Whitney U-test, p = 0.001). Eighty-four (77%) patients with a positive viral load were outside the target age range specified in the current National Recommendations for free-of-charge screening. CONCLUSIONS The non-negligible prevalence of patients with a positive viral load among an unselected group of hospitalised patients suggests that such settings could effectively enhance screening programmes aimed at HCV elimination. Additionally, this approach may help identify patients who are not currently included in the National Recommendations.
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Affiliation(s)
- Alberto Ferrarese
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Paola Zanaga
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Sara Battistella
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Silvia Zanella
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Teresa Zappitelli
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | | | - Monia Pacenti
- Microbiology Unit, Padua University Hospital, Padua, Italy
| | | | - Greta Bordignon
- Direzione Medica Ospedaliera, Padua University Hospital, Padua, Italy
| | - Federica Gomiero
- Information Technology System Unit, Padua University Hospital, Padua, Italy
| | - Magdalena Epifani
- Information Technology System Unit, Padua University Hospital, Padua, Italy
| | - Marco Villano
- Information Technology System Unit, Padua University Hospital, Padua, Italy
| | - Martina Gambato
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Alberto Zanetto
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Nora Cazzagon
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Liliana Chemello
- Unit of Internal Medicine and Hepatology Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Francesca Pasin
- First Chair of Internal Medicine and Thrombotic and Haemorrhagic Disease Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Lorenzo Calò
- Nephrology, Dialysis and Transplantation Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Andrea Doria
- Unit of Rheumatology, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Livio Trentin
- Hematology Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Sabino Illiceto
- Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, Padua University Hospital, Padua, Italy
| | - Angelo Avogaro
- Unit of Metabolic Disease, Department of Medicine, Padua University Hospital, Padua, Italy
| | | | - Paolo Simioni
- First Chair of Internal Medicine and Thrombotic and Haemorrhagic Disease Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | - Paolo Angeli
- Unit of Internal Medicine and Hepatology Unit, Department of Medicine, Padua University Hospital, Padua, Italy
| | | | - Patrizia Burra
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
| | - Annamaria Cattelan
- Infectious and Tropical Diseases Unit, Padua University Hospital, Padua, Italy
| | - Francesco Paolo Russo
- Gastroenterology and Multivisceral Transplant Unit, Padua University Hospital, Padua, Italy
- Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy
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33
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Voeller AS, Johannessen A, Abebe ZZ, Adugna W, Gamkrelidze I, Seyoum E, Gebremedhin LT, Meselu MG, Nigussie SA, Silesh A, Razavi H, Razavi‐Shearer D, Tirsite G, Desalegn H. The Disease and Economic Burden of HBV and HCV in Ethiopia. J Viral Hepat 2025; 32:e14053. [PMID: 39815994 PMCID: PMC11736537 DOI: 10.1111/jvh.14053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Revised: 10/25/2024] [Accepted: 12/03/2024] [Indexed: 01/18/2025]
Abstract
As the second most populated country in Africa, Ethiopia needs public health measures to control diseases that impact its population. The goal of this study is to analyse disease burdens of HBV and HCV, while also highlighting their estimated associated costs for the country. A literature review and a Delphi process reflecting input of Ethiopian experts and the National Viral Hepatitis Technical Working Group were used to complement mathematical modelling to estimate HBV and HCV disease and economic burdens. Two scenarios were created for HCV: 2023 base and WHO elimination. For HBV, three scenarios were created: 2023 base, WHO elimination and universal birth dose. Using current country costs, each scenario was also examined through an economic lens. There were an estimated 7.6 million HBV infections in 2023. To impact transmission, a universal birth dose and pregnant women screening program would allow Ethiopia to vaccinate approximately 3.9 million infants annually, with a budget of $4.68 million USD, meeting the WHO prevalence elimination target (≤ 0.1% in ≤ 5-year-olds) by 2043. Ethiopia had an estimated 690,000 HCV infections in 2023. To achieve HCV elimination, the country would need to expand screening and treatment to 74,000 individuals annually with a peak budget of $12 million USD per year until 2032, decreasing to less than $2 million USD in 2035. Ethiopia can begin making steps towards elimination of HBV through expansion of birth dose vaccination. However, larger investments will be needed to scale-up treatment and diagnosis interventions for both diseases.
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Affiliation(s)
| | - Asgeir Johannessen
- Department of Infectious DiseasesVestfold Hospital TrustTønsbergNorway
- Sustainable Health Unit (SUSTAINIT), Faculty of MedicineUniversity of OsloOsloNorway
| | | | | | | | - Eleni Seyoum
- Joint United Nations Program on HIV/AIDS (UNAIDS) EthiopiaAddis AbabaEthiopia
| | | | | | | | - Asmamaw Silesh
- Clinton Health Access Initiative EthiopiaAddis AbabaEthiopia
| | - Homie Razavi
- Center for Disease Analysis FoundationLafayetteColoradoUSA
| | | | - Ghion Tirsite
- World Health Organization EthiopiaAddis AbabaEthiopia
| | - Hailemichael Desalegn
- Department of Internal MedicineSt. Paul's Hospital Millennium Medical CollegeAddis AbabaEthiopia
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Dashjamts G, Ganzorig AE, Tsedendorj Y, Daramjav D, Khayankhyarvaa E, Ulziitsogt B, Nergui O, Dondov G, Badamjav T, Lonjid T, Huang CF, Liang PC, Batsaikhan B, Dai CY. Change in Estimated Glomerular Filtration Rate After Direct-Acting Antiviral Treatment in Chronic Hepatitis C Patients. Diseases 2025; 13:26. [PMID: 39997033 PMCID: PMC11854603 DOI: 10.3390/diseases13020026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Revised: 01/17/2025] [Accepted: 01/17/2025] [Indexed: 02/26/2025] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection accelerates the progression of chronic kidney disease (CKD), increasing the risk of kidney failure and end-stage renal disease. Direct-acting antiviral (DAA) therapies for HCV infection inhibit viral replication by 95-97%, leading to a sustained virologic response. Our objective was to assess renal function in patients with chronic HCV infection in Taiwan after receiving DAA therapy. GOAL Our study included 4823 patients with HCV infection who were undergoing DAA therapy. Renal function was evaluated by calculating the glomerular filtration rate (eGFR). eGFR assessed at the initiation of the treatment, during treatment, and at 3 months, 6 months, 1 year, and 3 years after completion of treatment. The baseline demographic and laboratory parameters of the study participants were evaluated, and the results were analyzed using statistical methods. RESULTS The average age of the study participants was 61.35 ± 12.50 years, and 54.5% of were male. The mean of eGFR in baseline and after treatment showed a decrease. Liver fibrosis scores (FIB4, APRI, Fibroscan) and liver function tests were significantly improved after DAA treatment (p = 0.001). However, white blood count (5.41 ± 1.7 vs. 5.73 ± 1.9), platelet count (168.04 ± 74.0 vs. 182.11 ± 69.4), and creatinine levels (1.05 ± 1.3 vs. 1.12 ± 1.3) increased after treatment (p = 0.001). The number of patients with an eGFR of 60 mL/min/1.73 m2 decreased both during and after treatment (p < 0.001). Among patients with CKD, eGFR improved after DAA treatment (n = 690, 35.93 ± 19.7 vs. 38.71 ± 23.8; 95% CI -3.56-1.98; p = 0.001). Logistic regression analysis revealed that renal function improved in patients with CKD who had an eGFR of less than 60 mL/min/1.73 m2 before DAA treatment (OR 1.62, 95% CI 1.37-1.91, p = 0.001). CONCLUSIONS In individuals with CKD and a baseline eGFR < 60 mL/min per 1.73 m2, eGFR level was increased during DAA treatment. This suggests that initiating DAA therapy in HCV-infected patients, even those without clinical manifestations, could be a crucial strategy to prevent further decline in renal function.
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Affiliation(s)
- Gantogtokh Dashjamts
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Amin-Erdene Ganzorig
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Yumchinsuren Tsedendorj
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Dolgion Daramjav
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Enkhmend Khayankhyarvaa
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Bolor Ulziitsogt
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Otgongerel Nergui
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Ganchimeg Dondov
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Tegshjargal Badamjav
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
- Department of Biological Sciences, School of Life Sciences, Inner Mongolia University, Hohhot 010031, China
| | - Tulgaa Lonjid
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
| | - Chung-Feng Huang
- Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807378, Taiwan; (C.-F.H.); (P.-C.L.)
- Department of Occupational and Environmental Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807378, Taiwan
| | - Po-Cheng Liang
- Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807378, Taiwan; (C.-F.H.); (P.-C.L.)
- Department of Occupational and Environmental Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807378, Taiwan
| | - Batbold Batsaikhan
- Department of Internal Medicine, Institute of Medical Sciences, Ministry of Economy and Development, Ulaanbaatar 14210, Mongolia; (G.D.); (A.-E.G.); (Y.T.); (D.D.); (E.K.); (B.U.); (O.N.); (G.D.); (T.B.); (T.L.)
- Department of Health Research, Graduate School, Mongolian National University of Medical Sciences, Ulaanbaatar 14210, Mongolia
| | - Chia-Yen Dai
- Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807378, Taiwan; (C.-F.H.); (P.-C.L.)
- Ph.D. Program in Environmental and Occupational Medicine, Drug Development and Value Creation Research Center, Kaohsiung Medical University, Kaohsiung 807378, Taiwan
- College of Professional Studies, National Pingtung University of Science and Technology, Pingtung 91201, Taiwan
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Suzuki H, Fujiwara N, Singal AG, Baumert TF, Chung RT, Kawaguchi T, Hoshida Y. Prevention of liver cancer in the era of next-generation antivirals and obesity epidemic. Hepatology 2025:01515467-990000000-01139. [PMID: 39808821 DOI: 10.1097/hep.0000000000001227] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2024] [Accepted: 10/07/2024] [Indexed: 01/16/2025]
Abstract
Preventive interventions are expected to substantially improve the prognosis of patients with primary liver cancer, predominantly HCC and cholangiocarcinoma. HCC prevention is challenging in the face of the evolving etiological landscape, particularly the sharp increase in obesity-associated metabolic disorders, including metabolic dysfunction-associated steatotic liver disease. Next-generation anti-HCV and HBV drugs have substantially reduced, but not eliminated, the risk of HCC and have given way to new challenges in identifying at-risk patients. The recent development of new therapeutic agents and modalities has opened unprecedented opportunities to refine primary, secondary, and tertiary HCC prevention strategies. For primary prevention (before exposure to risk factors), public health policies, such as universal HBV vaccination, have had a substantial prognostic impact. Secondary prevention (after or during active exposure to risk factors) includes regular HCC screening and chemoprevention. Emerging biomarkers and imaging modalities for HCC risk stratification and detection may enable individual risk-based personalized and cost-effective HCC screening. Clinical studies have suggested the potential utility of lipid-lowering, antidiabetic/obesity, and anti-inflammatory agents for secondary prevention, and some of them are being evaluated in prospective clinical trials. Computational and experimental studies have identified potential chemopreventive strategies directed at diverse molecular, cellular, and systemic targets for etiology-specific and/or agnostic interventions. Tertiary prevention (in conjunction with curative-intent therapies for HCC) is an area of active research with the development of new immune-based neoadjuvant/adjuvant therapies. Cholangiocarcinoma prevention may advance with recent efforts to elucidate risk factors. These advances will collectively lead to substantial improvements in liver cancer mortality rates.
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Affiliation(s)
- Hiroyuki Suzuki
- Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA
- Department of Medicine, Division of Gastroenterology, Kurume University School of Medicine, Kurume, Japan
| | - Naoto Fujiwara
- Department of Gastroenterology and Hepatology, Graduate School of Medicine, Mie University, Tsu, Japan
| | - Amit G Singal
- Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA
| | - Thomas F Baumert
- Inserm, Institute for Translational Medicine and Liver Diseases, University of Strasbourg, France
- IHU Strasbourg, Strasbourg, France
- Gastroenterology and Hepatology Service, Strasbourg University Hospitals, Strasbourg, France
| | - Raymond T Chung
- Department of Medicine, GI Division, Liver Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Takumi Kawaguchi
- Department of Medicine, Division of Gastroenterology, Kurume University School of Medicine, Kurume, Japan
| | - Yujin Hoshida
- Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA
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Hage K, Boyd A, van Santen DK, Brinkman K, Arends J, Lauw F, Rijnders B, van Eeden A, van der Valk M, Newsum A, Matser A, Schinkel J, Prins M. Hepatitis C Treatment and Behavioral Risk Among Men Who Have Sex With Men With HIV: Comparing Interferon and Direct-Acting Antiviral Eras. J Acquir Immune Defic Syndr 2025; 98:90-98. [PMID: 39443822 DOI: 10.1097/qai.0000000000003550] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2024] [Accepted: 10/08/2024] [Indexed: 10/25/2024]
Abstract
BACKGROUND Little is known about the effect of hepatitis C virus (HCV) treatment on sexual risk behavior among men who have sex with men (MSM) with HIV by treatment type (interferon [IFN]-based vs direct-acting antiviral [DAA]-based). SETTING MSM with HIV and recently acquired HCV infection enrolled in the MSM Observational Study of Acute Infection with hepatitis C (MOSAIC) cohort. METHODS Using data from 2009 to 2018, we evaluated risk behavior through a validated HCV risk score (where ≥2 indicated high risk) and its individual risk behaviors. Levels of risk behavior before, during, and after treatment were modeled for each treatment episode using linear and logistic regression with Generalized Estimating Equations adjusting for DAA availability and number of reinfections. RESULTS One hundred forty MSM with a median age of 45 years (interquartile range = 40-49) yielded 180 treatment episodes (n = 131 IFN-based, n = 49 DAA-based). Adjusted mean risk score before, during, and after treatment was 2.4 (95% confidence interval [CI] = 2.1 to 2.6), 0.9 (95% CI = 0.8 to 1.0), and 1.7 (95% CI = 1.5 to 1.8), respectively. Before treatment, no differences in mean HCV risk score or proportion of specific behaviors were found between the regimen groups. During treatment, MSM treated with DAAs had a higher average risk score and proportion of receptive condomless anal sex, sharing toys and unprotected fisting than those treated with IFN. After treatment, the proportion sharing straws were significantly higher in MSM treated with DAAs than in MSM treated with IFN. CONCLUSIONS MSM treated with DAAs, compared with MSM treated with IFN, had higher levels of HCV-related risk behavior during treatment. The higher risk of HCV reinfection in the DAA-era underscores the need for ongoing HCV testing and behavioral interventions against HCV.
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Affiliation(s)
- Kris Hage
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Amsterdam UMC, University of Amsterdam, Infectious Diseases, Amsterdam, the Netherlands
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
| | - Anders Boyd
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Amsterdam UMC, University of Amsterdam, Infectious Diseases, Amsterdam, the Netherlands
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
- Stichting hiv monitoring, Amsterdam, the Netherlands
| | - Daniela K van Santen
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Disease Elimination Program, Burnet Institute, Melbourne, Australia
| | - Kees Brinkman
- Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands
| | - Joop Arends
- Department of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Fanny Lauw
- Department of Internal Medicine, Medical Centre Jan van Goyen, Amsterdam, the Netherlands
| | - Bart Rijnders
- Department of Internal Medicine and Infectious Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands
| | - Arne van Eeden
- Department of Internal Medicine, DC Klinieken Lairesse, Amsterdam, the Netherlands; and
| | - Marc van der Valk
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
- Stichting hiv monitoring, Amsterdam, the Netherlands
| | - Astrid Newsum
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
| | - Amy Matser
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
| | - Janke Schinkel
- Department of Medical Microbiology & Infection Prevention, Section of Clinical Virology, Amsterdam Infection & Immunity Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
| | - Maria Prins
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
- Amsterdam UMC, University of Amsterdam, Infectious Diseases, Amsterdam, the Netherlands
- Amsterdam Institute for Infection and Immunity, Infectious Diseases, Amsterdam, the Netherlands
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Fleurence RL, Alter HJ, Collins FS, Ward JW. Global Elimination of Hepatitis C Virus. Annu Rev Med 2025; 76:29-41. [PMID: 39485830 DOI: 10.1146/annurev-med-050223-111239] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/03/2024]
Abstract
Hepatitis C virus (HCV) is predominantly transmitted through parenteral exposures to infectious blood or body fluids. In 2019, approximately 58 million people worldwide were infected with HCV, and 290,000 deaths occurred due to hepatitis C-related conditions, despite hepatitis C being curable. There are substantial barriers to elimination, including the lack of widespread point-of-care diagnostics, cost of treatment, stigma associated with hepatitis C, and challenges in reaching marginalized populations, such as people who inject drugs. The World Health Organization (WHO) has set goals to eliminate hepatitis C by 2030. Several countries, including Australia, Egypt, Georgia, and Rwanda, have made remarkable progress toward hepatitis C elimination. In the United States, the Biden-Harris administration recently issued a plan for the national elimination of hepatitis C. Global progress has been uneven, however, and will need to accelerate considerably to reach the WHO's 2030 goals. Nevertheless, the global elimination of hepatitis C is within reach and should remain a high public health priority.
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Affiliation(s)
- Rachael L Fleurence
- Office of the Director, National Institutes of Health, Bethesda, Maryland, USA;
| | - Harvey J Alter
- Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
| | - Francis S Collins
- National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA
| | - John W Ward
- Task Force for Global Health, Decatur, Georgia, USA
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Chen Y, Bao Y, Yan M, Jin H, Yao K, Zhang C, Li W, Wu B. Achieving Hepatitis C Micro-Elimination in Chinese Injecting Drug Users: A Dynamic Network Modeling Study. Infect Dis Ther 2025; 14:181-197. [PMID: 39663286 PMCID: PMC11782747 DOI: 10.1007/s40121-024-01084-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2024] [Accepted: 11/08/2024] [Indexed: 12/13/2024] Open
Abstract
INTRODUCTION The World Health Organization (WHO) has established objectives for eradicating the hepatitis C virus (HCV). People who inject drugs (PWID), a major driver of HCV transmission, are an essential part of China's hepatitis C elimination program. This study aimed to estimate the requisite screening and antiviral treatment levels to achieve these goals among people who inject drugs in China and identify the most cost-effective strategy. METHODS This study utilized models based on dynamic social networks to simulate HCV transmission and disease progression among people who inject drugs in China, incorporating a cost-effectiveness analysis from a healthcare perspective. RESULTS To achieve the WHO targets, a minimum screening and treatment rate of 10% is required to meet the mortality goal, while a 25% rate is necessary for the incidence goal. The most cost-effective strategy includes a 25% screening rate and a 95% treatment rate. Compared to no intervention, this approach significantly reduces costs by - $85,873.38 (95% CI - $94,311.16 to - $77,435.59) and adds 24.66 (95% CI 23.68 to - 25.64) quality-adjusted life years. The intervention is dominant, with a cost-effectiveness ratio of - $3482.29 (95% CI - $3982.73 to - $3020.11) per quality-adjusted life year. CONCLUSION Achieving the WHO's hepatitis C virus elimination targets among people who inject drugs in China is feasible and cost-saving.
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Affiliation(s)
- Ying Chen
- Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, 241 Huaihai West Road, Shanghai, 200030, China
| | - Yun Bao
- West China School of Pharmacy, Sichuan University, Chengdu, 610000, Sichuan, China
| | - Mengxia Yan
- Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, 241 Huaihai West Road, Shanghai, 200030, China
| | - Huajie Jin
- King's Health Economics (KHE), Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Kaijie Yao
- Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, 241 Huaihai West Road, Shanghai, 200030, China
| | - Chi Zhang
- Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China
| | - Wen Li
- Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China
| | - Bin Wu
- Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, 241 Huaihai West Road, Shanghai, 200030, China.
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Ma X, Huang L, Yu M, Dong R, Wang Y, Chen H, Yu R, Huang P, Wang J. Dynamic Prediction of the Risk of Hepatocellular Carcinoma After DAA Treatment for Hepatitis C Patients. Cancer Control 2025; 32:10732748251316609. [PMID: 39957415 PMCID: PMC11831632 DOI: 10.1177/10732748251316609] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Revised: 11/23/2024] [Accepted: 01/06/2025] [Indexed: 02/18/2025] Open
Abstract
OBJECTIVES The aim of this study was to develop and internally validate a hepatocellular carcinoma (HCC) risk prediction model incorporating repeated-measures data (longitudinal model), and compare with baseline predictions. METHODS A total of 1097 participants with chronic hepatitis C after direct-acting antivirals (DAA) treatment were included in this prospective cohort study. The framework of joint models for longitudinal and survival data was used to construct the longitudinal prediction model. For comparison, a baseline model incorporating the same predictors was constructed through the multivariate Cox regression models. Model performance was evaluated using dynamic discrimination index (DDI), areas under the receiver-operating characteristics curves (AUROC), and Brier scores. RESULTS Over a median follow-up of 7.25 years, 60 patients (5.5%) developed HCC. Key risk factors identified were aspartate aminotransferase (AST), cholinesterase, gamma-glutamyl transferase (GGT), albumin, hemoglobin (Hb), platelet count, alpha-fetoprotein (AFP), antigen-125 (CA-125), and carcinoembryonic antigen (CEA). The final joint model, with GGT and CEA removed, showed superior average predictive performance (DDI = .871) compared to models with all predictors included. Validation showed high predictive accuracy for HCC, with AUROCs above .9 for 1-, 3-, 4-, and 5-year predictions. In comparison, the baseline Cox model only achieved mediocre AUROCs of .7 (.75, .67, .69, and .67, respectively). CONCLUSION Compared to static models, our dynamic prediction model can predict the risk of HCC in patients after DAA treatment more accurately, providing better information to distinguish high-risk populations.
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Affiliation(s)
- Xinyan Ma
- Department of Epidemiology, Center for Global Health, National Vaccine Innovation Platform, School of Public Health, Nanjing Medical University, Nanjing, China
| | - Lili Huang
- NHC Key Laboratory of Contraceptives Vigilance and Fertility Surveillance/Jiangsu Health Development Research Center, Nanjing, China
| | - Meijie Yu
- Department of Epidemiology, Center for Global Health, National Vaccine Innovation Platform, School of Public Health, Nanjing Medical University, Nanjing, China
| | - Rui Dong
- Department of Fundamental and Community Nursing, School of Nursing, Nanjing Medical University, Nanjing, China
| | - Yifan Wang
- Department of Infectious Disease, Jurong Hospital Affiliated to Jiangsu University, Jurong, China
| | - Hongbo Chen
- Department of Infectious Disease, Jurong Hospital Affiliated to Jiangsu University, Jurong, China
| | - Rongbin Yu
- Department of Epidemiology, Center for Global Health, National Vaccine Innovation Platform, School of Public Health, Nanjing Medical University, Nanjing, China
| | - Peng Huang
- Department of Epidemiology, Center for Global Health, National Vaccine Innovation Platform, School of Public Health, Nanjing Medical University, Nanjing, China
| | - Jie Wang
- Department of Fundamental and Community Nursing, School of Nursing, Nanjing Medical University, Nanjing, China
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Tonutti A, Polverini D, De Nicola S, Ceribelli A, Soleri M, De Santis M, Aghemo A, Selmi C, Pugliese N. The evolving scenario of HCV-related mixed cryoglobulinemia and B-cell lymphoma in the era of direct-acting antivirals. Expert Rev Anti Infect Ther 2025; 23:19-30. [PMID: 39749733 DOI: 10.1080/14787210.2024.2442475] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Accepted: 12/11/2024] [Indexed: 01/04/2025]
Abstract
INTRODUCTION Hepatitis C virus (HCV) infection represents a significant global health burden, particularly due to its extrahepatic immune-mediated manifestations, such as mixed cryoglobulinemia, associated vasculitis (CryoVas), and non-Hodgkin B-cell lymphoma (B-NHL), which pose significant challenges. The advent of direct-acting antiviral (DAA) has changed the therapeutic landscape for HCV-related complications. AREAS COVERED This review explores the evolving epidemiology and management of HCV extrahepatic manifestation and lymphoproliferative disorders in the era of DAAs. It examines the efficacy of DAAs in controlling CryoVas and their complex role in HCV-related B-cell lymphoma. The literature search included studies on the immunological dynamics between HCV, CryoVas, and lymphoma, focusing on the impact of sustained virological response (SVR) on immune dysregulation, relapse risk, refractory disease, and patient stratification based on risk profiles. EXPERT OPINION DAAs have significantly improved the management of HCV-related CryoVas and autoimmune manifestations, but remain a challenge in refractory cases and the risk of lymphoma. Future strategies should focus on refining risk stratification and integrating new therapeutic approaches to better address immune dysregulation and associated complications.
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Affiliation(s)
- Antonio Tonutti
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Davide Polverini
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Stella De Nicola
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Angela Ceribelli
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Matteo Soleri
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
| | - Maria De Santis
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Alessio Aghemo
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Carlo Selmi
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Nicola Pugliese
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy
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Guo C, Liu Z, Fan H, Wang H, Zhang X, Zhao S, Li Y, Han X, Wang T, Chen X, Zhang T. Machine-learning-based plasma metabolomic profiles for predicting long-term complications of cirrhosis. Hepatology 2025; 81:168-180. [PMID: 38630500 DOI: 10.1097/hep.0000000000000879] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2023] [Accepted: 03/24/2024] [Indexed: 06/04/2024]
Abstract
BACKGROUND AND AIMS The complications of liver cirrhosis occur after long asymptomatic stages of progressive fibrosis and are generally diagnosed late. We aimed to develop a plasma metabolomic-based score tool to predict these events. APPROACH AND RESULTS We enrolled 64,005 UK biobank participants with metabolomic profiles. Participants were randomly divided into the training (n=43,734) and validation cohorts (n=20,271). Liver cirrhosis complications were defined as hospitalization for liver cirrhosis or presentation with HCC. An interpretable machine-learning framework was applied to learn the metabolomic states extracted from 168 circulating metabolites in the training cohort. An integrated nomogram was developed and compared to conventional and genetic risk scores. We created 3 groups: low-risk, middle-risk, and high-risk through selected cutoffs of the nomogram. The predictive performance was validated through the area under a time-dependent receiver operating characteristic curve (time-dependent AUC), calibration curves, and decision curve analysis. The metabolomic state model could accurately predict the 10-year risk of liver cirrhosis complications in the training cohort (time-dependent AUC: 0.84 [95% CI: 0.82-0.86]), and outperform the fibrosis-4 index (time-dependent AUC difference: 0.06 [0.03-0.10]) and polygenic risk score (0.25 [0.21-0.29]). The nomogram, integrating metabolomic state, aspartate aminotransferase, platelet count, waist/hip ratio, and smoking status showed a time-dependent AUC of 0.930 at 3 years, 0.889 at 5 years, and 0.861 at 10 years in the validation cohort, respectively. The HR in the high-risk group was 43.58 (95% CI: 27.08-70.12) compared with the low-risk group. CONCLUSIONS We developed a metabolomic state-integrated nomogram, which enables risk stratification and personalized administration of liver-related events.
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Affiliation(s)
- Chengnan Guo
- Shanghai Institute of Infectious Disease and Biosecurity, School of Public Health, Fudan University, Shanghai, China
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Zhenqiu Liu
- State Key Laboratory of Genetic Engineering, Human Phenome Institute, and School of Life Sciences, Fudan University, Shanghai, China
- Fudan University Taizhou Institute of Health Sciences, Taizhou, China
| | - Hong Fan
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
- Fudan University Taizhou Institute of Health Sciences, Taizhou, China
| | - Haili Wang
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Xin Zhang
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Shuzhen Zhao
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Yi Li
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Xinyu Han
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Tianye Wang
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
| | - Xingdong Chen
- State Key Laboratory of Genetic Engineering, Human Phenome Institute, and School of Life Sciences, Fudan University, Shanghai, China
- Fudan University Taizhou Institute of Health Sciences, Taizhou, China
| | - Tiejun Zhang
- Shanghai Institute of Infectious Disease and Biosecurity, School of Public Health, Fudan University, Shanghai, China
- Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai, China
- Fudan University Taizhou Institute of Health Sciences, Taizhou, China
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Kimura M, Nishikawa T, Shimakami T, Terashima T, Horii R, Fukuda M, Yoshita M, Takata N, Hayashi T, Funaki M, Nio K, Takatori H, Arai K, Yamashita T, Honda M, Tanaka J, Kaneko S, Yamashita T. Higher FIB-4 index at baseline predicts development of liver cancer in a community-based cohort with viral hepatitis. Glob Health Med 2024; 6:404-415. [PMID: 39741996 PMCID: PMC11680450 DOI: 10.35772/ghm.2024.01008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2024] [Revised: 03/26/2024] [Accepted: 05/14/2024] [Indexed: 01/03/2025]
Abstract
Hepatitis B and C (HBV and HCV) testing has been performed in Japan since 2002 and is subsidized by central and prefectural governments. A follow-up program for HBV- or HCV-infected persons was started at that time in Ishikawa Prefecture. This study analyzed the long-term follow-up data from this program. In total, 1029 participants in the Ishikawa Hepatitis Follow-up Program (HBV-infected, n = 535; HCV-infected, n = 494) were enrolled. Clinical data between the first visit and the most recent visit by March 2019 were collected. In the HBV-infected group, 384 persons (71.8%) were asymptomatic carriers, 133 (24.9%) developed chronic hepatitis, 15 (2.8%) developed compensated liver cirrhosis, and 3 (0.6%) developed decompensated liver cirrhosis. Ninety (16.8%) were treated with nucleotide/nucleoside analogs. Sixteen (3.0%) developed liver cancer. In the HCV-infected group, 427 persons (86.4%) developed chronic hepatitis, 46 (9.3%) developed compensated liver cirrhosis, and 21 (4.3%) developed decompensated liver cirrhosis. Forty-eight (9.7%) developed liver cancer. Three hundred and seventy-eight (76.5%) received antiviral therapy (a direct-acting antiviral in 166, interferon-based treatment followed by a direct-acting antiviral in 73, and interferon-based treatment in 139). The subsidy system was used by 270 persons (71.4%). Sustained virological response was confirmed in 340 persons (68.8%). A higher FIB-4 index at the first visit was a significant risk factor for liver cancer in HBV-infected and HCV-infected persons. The Ishikawa Hepatitis Follow-up Program has revealed the clinical course of HBV and HCV infection in community-dwelling individuals. The results will be used for micro-elimination at a prefectural level.
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Affiliation(s)
- Makiko Kimura
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Tomoki Nishikawa
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Tetsuro Shimakami
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Takeshi Terashima
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Rika Horii
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Masako Fukuda
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Mika Yoshita
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Noboru Takata
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Tomoyuki Hayashi
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Masaya Funaki
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Kouki Nio
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Hajime Takatori
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Kuniaki Arai
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Tatsuya Yamashita
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
- WHO Collaborating Center for Viral Hepatitis and Liver Cancer in WPRO, Kanazawa, Ishikawa, Japan
| | - Masao Honda
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Junko Tanaka
- Department of Epidemiology, Infectious Disease Control and Prevention, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima City, Hiroshima, Japan
| | - Shuichi Kaneko
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
| | - Taro Yamashita
- Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan
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Chen S, Wang Q, An Y, Chen Y, Liu H, Tan W, Zhou X, Xing D, Zhang Y. Spatiotemporal distribution characteristics and impact factors of hepatitis C in Chongqing, China, 2014-2020. BMJ Open 2024; 14:e077935. [PMID: 39719289 PMCID: PMC11667379 DOI: 10.1136/bmjopen-2023-077935] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2023] [Accepted: 10/17/2024] [Indexed: 12/26/2024] Open
Abstract
OBJECTIVES This study aimed to explore the spatial and temporal distribution of hepatitis C and its influencing factors in Chongqing, providing a scientific basis for the relevant departments to formulate targeted preventive measures for the high prevalence of hepatitis C in the region and population. DESIGN We collected data on hepatitis C cases in Chongqing (located in the southwest of China) from 2014 to 2020, and analysed the spatiotemporal heterogeneity of hepatitis C incidence in different populations and identified factors that might influence the incidence of hepatitis C by constructing a Bayesian spatiotemporal model. SETTINGS The study subjects included clinically diagnosed cases and confirmed cases of hepatitis C with current address in Chongqing and onset date between 1 January 2014 and 31 December 2020. PARTICIPANTS The study used aggregated data, including 33 900 clinically diagnosed cases and confirmed cases of hepatitis C. RESULTS From 2014 to 2020, the high-risk areas of hepatitis C were primarily concentrated in the main and new urban areas of Chongqing. In contrast, the low-risk areas were mainly found in southeast and northeast Chongqing. There was also an increasing trend in the risk of incidence in the low-risk areas. Analysis of different populations revealed that men aged 45-59 years had a higher risk of developing hepatitis C in the main urban area compared with other age groups. Additionally, the risk for this population group showed an increasing trend in the southeast and northeast of Chongqing as well as the main urban area. Among women, the rising trend of hepatitis C risk was stronger for those aged 30-44 years in southeast Chongqing and for those aged 45-59 years in northeast Chongqing compared with other age groups. The analysis of influencing factors found that gross domestic product per capita, population density and the proportion of tertiary industry were associated with an increased risk of hepatitis C. CONCLUSIONS High-risk areas for hepatitis C virus were mainly located in the main and new urban areas of Chongqing, where the male prime-age population was the focus of prevention and treatment. In the future, the relevant authorities should concentrate on high-risk areas and at the same time strengthen screening and serological surveys for hepatitis C in low-risk areas and various populations, and raise public awareness of prevention, so as to reduce the incidence of hepatitis C.
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Affiliation(s)
- Saijuan Chen
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Qiuting Wang
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Yunyi An
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Ying Chen
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Hua Liu
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Weijie Tan
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Xinyun Zhou
- School of Public Health, Chongqing Medical University, Chongqing, China
| | - Dianguo Xing
- Office of Health Emergency, Chongqing Municipal Health Commission, Chongqing, China
| | - Yan Zhang
- School of Public Health, Chongqing Medical University, Chongqing, China
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Mbisa JL, Lapp Z, Bibby DF, Phillips LT, Manso CF, Packer S, Simmons R, Harris K, Mohan J, Chinnappan L, Leitner T, Bradshaw D. Identification of 2 Novel Subtypes of Hepatitis C Virus Genotype 8 and a Potential New Genotype Successfully Treated With Direct Acting Antivirals. J Infect Dis 2024; 230:e1254-e1262. [PMID: 38717937 PMCID: PMC11646602 DOI: 10.1093/infdis/jiae253] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2024] [Revised: 04/24/2024] [Accepted: 05/06/2024] [Indexed: 07/10/2024] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) has high genetic diversity and is classified into 8 genotypes and >90 subtypes, with some endemic to specific world regions. This could compromise direct-acting antiviral efficacy and global HCV elimination. METHODS We characterized HCV subtypes "rare" in the United Kingdom (non-1a/1b/2b/3a/4d) by means of whole-genome sequencing via a national surveillance program. Genetic analyses to determine the genotype of samples with unresolved genotypes were undertaken by comparison with International Committee on Taxonomy of Viruses HCV reference sequences. RESULTS Two HCV variants were characterized as being closely related to the recently identified genotype (GT) 8, with >85% pairwise genetic distance similarity to GT8 sequences and within the typical intersubtype genetic distance range. The individuals infected by the variants were UK residents originally from Pakistan and India. In contrast, a third variant was only confidently identified to be more similar to GT6 compared with other genotypes across 6% of the genome and was isolated from a UK resident originally from Guyana. All 3 were cured with pangenotypic direct-acting antivirals (sofosbuvir-velpatasvir or glecaprevir-pibrentasvir) despite the presence of resistance polymorphisms in NS3 (80K/168E), NS5A (28V/30S/62L/92S/93S) and NS5B (159F). CONCLUSIONS This study expands our knowledge of HCV diversity by identifying 2 new GT8 subtypes and potentially a new genotype.
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Affiliation(s)
- Jean L Mbisa
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Bloodborne and Sexually Transmitted Infections, London, United Kingdom
| | - Zena Lapp
- Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, New Mexico, USA
| | - David F Bibby
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
| | - Laura T Phillips
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Bloodborne and Sexually Transmitted Infections, London, United Kingdom
| | - Carmen F Manso
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
| | - Simon Packer
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
| | - Ruth Simmons
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Bloodborne and Sexually Transmitted Infections, London, United Kingdom
| | - Kathryn Harris
- Royal London Hospital, Barts Health NHS Trust, London, United Kingdom
| | - Jaiganesh Mohan
- Warrington and Halton Teaching Hospitals NHS Foundation Trust, Warrington, United Kingdom
| | - Lalitha Chinnappan
- Warrington and Halton Teaching Hospitals NHS Foundation Trust, Warrington, United Kingdom
| | - Thomas Leitner
- Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, New Mexico, USA
| | - Daniel Bradshaw
- Virus Reference Department, UK Health Security Agency, London, United Kingdom
- National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Bloodborne and Sexually Transmitted Infections, London, United Kingdom
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Flisiak R, Zarębska-Michaluk D, Martonik D, Janocha-Litwin J, Berak H, Sitko M, Mazur W, Janczewska E, Lorenc B, Klapaczyński J, Laurans Ł, Dybowska D, Piekarska A, Tudrujek-Zdunek M, Dobrowolska K, Parfieniuk-Kowerda A. Treatment of Hepatitis C Virus Infections Among Patients of Ukrainian Origin During the Influx of War Refugees to Poland. J Clin Med 2024; 13:7641. [PMID: 39768565 PMCID: PMC11727857 DOI: 10.3390/jcm13247641] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2024] [Revised: 12/05/2024] [Accepted: 12/12/2024] [Indexed: 01/16/2025] Open
Abstract
Background: The wave of wartime migration from Ukraine has raised a number of concerns about infectious diseases, the prevalence of which is higher in Ukraine than in host countries, with hepatitis C virus (HCV) infection being one of them. Our analysis aimed to assess the percentage of HCV-infected Ukrainian refugees under care in Polish centers providing antiviral diagnosis and therapy, to evaluate their characteristics and the effectiveness of treatment with direct-acting antiviral drugs (DAAs). Methods: The analysis included patients of Polish and Ukrainian nationality treated for HCV infection between 2022 and 2024 in Polish hepatology centers. Data were collected retrospectively and completed online. Results: In the population of 3911 patients with chronic hepatitis C treated with DAAs in 16 Polish centers in 2022-2024, there were 429 war refugees from Ukraine, accounting for 11% of the total treated. The Ukrainian population was significantly younger (45.7 vs. 51 years, p < 0.001) and had a higher percentage of women (50.3% vs. 45.3%, p = 0.048) compared to Polish patients. Patients of Ukrainian origin had less advanced liver disease and were significantly less likely to have comorbidities and the need for comedications. Coinfection with human immunodeficiency virus was significantly more common in Ukrainians than in Polish patients, 16.1% vs. 5.9% (p < 0.001). The distribution of HCV genotypes (GTs) also differed; although GT1b predominated in both populations, its frequency was significantly higher in the Polish population (62.3% vs. 44.5%, p < 0.001), while the second most common GT3 was significantly more common in Ukrainian patients (30.5% vs. 16.2%, p < 0.001). Conclusions: Documented differences in patient characteristics did not affect the effectiveness of antiviral therapy, which exceeded 97% in both populations, but there was a higher rate of those lost to follow-up among Ukrainian patients.
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Affiliation(s)
- Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Białystok, Poland; (R.F.); (D.M.); (A.P.-K.)
| | - Dorota Zarębska-Michaluk
- Department of Infectious Diseases and Allergology, Jan Kochanowski University, 25-317 Kielce, Poland;
| | - Diana Martonik
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Białystok, Poland; (R.F.); (D.M.); (A.P.-K.)
| | - Justyna Janocha-Litwin
- Department of Infectious Diseases and Hepatology, Wrocław Medical University, 50-367 Wrocław, Poland;
| | - Hanna Berak
- Outpatient Clinic, Hospital for Infectious Diseases in Warsaw, 01-201 Warsaw, Poland;
| | - Marek Sitko
- Department of Infectious and Tropical Diseases, Jagiellonian University, 31-008 Kraków, Poland;
| | - Włodzimierz Mazur
- Clinical Department of Infectious Diseases, Medical University of Silesia, 41-500 Chorzów, Poland;
| | - Ewa Janczewska
- Department of Basic Medical Sciences, School of Public Health in Bytom, Medical University of Silesia, 40-055 Katowice, Poland;
| | - Beata Lorenc
- Pomeranian Center of Infectious Diseases, Medical University Gdańsk, 80-214 Gdańsk, Poland;
| | - Jakub Klapaczyński
- Department of Internal Medicine and Hepatology, National Medical Institute of the Ministry of the Interior and Administration, 02-507 Warsaw, Poland;
| | - Łukasz Laurans
- Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, 70-204 Szczecin, Poland;
| | - Dorota Dybowska
- Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, 85-030 Bydgoszcz, Poland;
| | - Anna Piekarska
- Department of Infectious Diseases and Hepatology, Medical University of Łódź, 90–419 Łódź, Poland;
| | | | | | - Anna Parfieniuk-Kowerda
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Białystok, Poland; (R.F.); (D.M.); (A.P.-K.)
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Zhou DQ, Liu JY, Zhao F, Zhang J, Liu LL, Jia JR, Cao ZH. Risk factors for hepatocellular carcinoma in cirrhosis: A comprehensive analysis from a decade-long study. World J Gastrointest Oncol 2024; 16:4625-4635. [PMID: 39678801 PMCID: PMC11577360 DOI: 10.4251/wjgo.v16.i12.4625] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2024] [Revised: 08/28/2024] [Accepted: 10/09/2024] [Indexed: 11/12/2024] Open
Abstract
BACKGROUND Cirrhosis is a significant risk factor for the development of hepatocellular carcinoma (HCC). Variability in HCC risk among patients with cirrhosis is notable, particularly when considering the diverse etiologies of cirrhosis. AIM To identify specific risk factors contributing to HCC development in patients with cirrhosis. METHODS This retrospective study analyzed data from cirrhotic patients at Beijing Youan Hospital from January 1, 2012 to September 30, 2022 with at least 6 mo of follow-up. Patient demographics, medical histories, etiologies, and clinical characteristics were examined. Cox regression analysis was used to analyze correlations of the above parameters with hepatocarcinogenesis, while competing risk regression was used to estimate their adjusted hazard ratios accounting for death. The cumulative incidence was plotted over time. RESULTS Overall, 5417 patients with cirrhosis (median age: 54 years; 65.8% males) were analyzed. Hepatitis B virus (HBV) was the most common etiology (23.3%), with 25% (n = 1352) developing HCC over a 2.9-year follow-up period. Patients with multiple etiologies had the HCC highest incidence (30.3%), followed by those with HBV-related cirrhosis (29.5%). Significant risk factors included male sex, advanced age, hepatitis C virus (HCV) infection, elevated blood ammonia, and low platelet count. Men had a higher 5-year HCC risk than women (37.0% vs 31.5%). HBV, HCV, and HBV/HCV co-infected patients had 5-year risks of HCC of 45.8%, 42.9%, and 48.1%, respectively, compared to 29.5% in nonviral hepatitis cases, highlighting the significant HCC risk from viral hepatitis, especially HBV, and underscores the importance of monitoring these high-risk groups. CONCLUSION In conclusion, HBV-related cirrhosis strongly correlates with HCC, with male sex, older age, viral hepatitis, elevated blood ammonia, and lower albumin and platelet levels increasing the risk of HCC.
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Affiliation(s)
- Da-Qiong Zhou
- Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
| | - Jiang-Yu Liu
- Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
| | - Feng Zhao
- Hepatology Center, Baoding People’s Hospital, Baoding 071000, Hebei Province, China
| | - Jing Zhang
- Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
| | - Li-Li Liu
- Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
| | - Jian-Ru Jia
- Hepatology Center, Baoding People’s Hospital, Baoding 071000, Hebei Province, China
| | - Zhen-Huan Cao
- Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
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Milošević I, Beronja B, Filipović A, Mitrović N, Simić J, Knežević N, Ranin J, Todorović N, Stevanović O, Radovanović-Spurnić A, Katanić N, Hristović D, Nikolić N. HCV Treatment Outcomes in PWID: Impact of Addiction History on SVR12. Microorganisms 2024; 12:2554. [PMID: 39770757 PMCID: PMC11677223 DOI: 10.3390/microorganisms12122554] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2024] [Revised: 12/05/2024] [Accepted: 12/10/2024] [Indexed: 01/11/2025] Open
Abstract
People who inject drugs (PWIDs) experience high rates of hepatitis C virus (HCV) infection, primarily due to needle sharing and limited healthcare access, resulting in a disproportionate disease burden within this population. This prospective study evaluated treatment outcomes in 432 adult patients with chronic hepatitis C (CHC) treated with direct-acting antivirals (DAAs) at the University Clinical Center of Serbia. Patients were categorized into two groups based on a history of drug addiction: PWIDs (163, 37.7%) and non-PWIDs (269, 62.3%). The PWID group was further categorized into subpopulations of problematic PWIDs (39, 23.9%), ex-PWIDs (124, 76.1%), and PWIDs on OST (96, 58.9%). The PWID group demonstrated significantly lower treatment adherence, with an intention-to-treat (ITT) rate of 82.8%, compared to 96.3% in the control group (p < 0.001). In contrast, no significant differences were observed in per-protocol (PP) outcomes between the two groups. Additionally, PWIDs were significantly younger (p < 0.001) and had higher rates of psychiatric disorders (p < 0.001), alcohol abuse (p < 0.001), and HCV genotype 1a (p < 0.001). Advanced fibrosis was predictor of PP treatment failure among PWIDs, while mood disorders and alcohol use disorder were associated with interruptions before the scheduled completion time. For non-PWIDs, older age and advanced fibrosis emerged as key predictors of PP treatment failure. The loss to follow-up was most commonly observed in the problematic PWID subgroup (p = 0.001). These findings highlight the importance of addressing barriers in PWIDs through integrated care strategies that concurrently manage addiction and HCV.
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Affiliation(s)
- Ivana Milošević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Branko Beronja
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Ana Filipović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
| | - Nikola Mitrović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Jelena Simić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
| | - Nataša Knežević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
| | - Jovana Ranin
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
| | - Nevena Todorović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
| | - Olja Stevanović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Aleksandra Radovanović-Spurnić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Nataša Katanić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Department of Infective Diseases, Faculty of Medicine, University of Pristina Temporarily Settled in Kosovska Mitrovica, 38220 Kosovska Mitrovica, Serbia
| | - Dejan Hristović
- Clinic for Infectious and Tropical Diseases, Military Academy of the University of Defence, Crnotravska 17, 11000 Belgrade, Serbia;
| | - Nataša Nikolić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (J.R.); (N.T.); (O.S.); (A.R.-S.); (N.K.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
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Randhawa B, Blosser N, Daly A, Storek J, Shaheen AA, Jamani K. Chronic liver disease after allogeneic hematopoietic cell transplantation. Cytotherapy 2024; 26:1514-1521. [PMID: 39046389 DOI: 10.1016/j.jcyt.2024.07.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2024] [Revised: 06/23/2024] [Accepted: 07/01/2024] [Indexed: 07/25/2024]
Abstract
BACKGROUND AIMS There are few descriptions of the epidemiology of chronic liver disease (CLD) after allogeneic hematopoietic stem cell transplantation (allo-HCT). Among those transplanted before 2000, viral hepatitis was the dominant cause of CLD. Recently, the prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD, previously known as nonalcoholic fatty liver disease) is increasing in the general population. In addition, survivors of allo-HCT are known to be at increased risk of metabolic syndrome. We set out to describe the epidemiology of CLD in a modern cohort of allo-HCT recipients. We hypothesized that MASLD would be the most common cause of CLD in the cohort. METHODS We undertook a retrospective cohort and nested case-control study of 2-year survivors of allo-HCT in Alberta transplanted between 2008 and 2018. RESULTS Among 392 2-year survivors of allo-HCT between 2008 and 2018, the prevalence of CLD was 41.8% and MASLD was identified in 56% of those with CLD, followed by iron overload in 47% of those with CLD. The prevalence of MASLD among the entire cohort was 46%. Although most patients developed CLD before 2 years post-transplant, there was a 13% cumulative incidence of new CLD after 2 years posttransplant. Grade 2-4 acute graft-versus-host disease and/or moderate-to-severe chronic graft-versus-host disease and pretransplant CLD were strongly associated with CLD. In the case-control study examining the association between cardiovascular risk factors and CLD, type 2 diabetes was associated with CLD. Cirrhosis developed in 1.5% of survivors, and MASLD was an underlying etiology in one half of these cases. There was no difference in overall survival and non-relapse mortality between those who did and did not develop CLD. CONCLUSIONS MASLD is the main cause of CLD in recent long-term survivors of allo-HCT and may be associated with post-transplant corticosteroid exposure and type 2 diabetes. We note a shift in the underlying etiology of CLD post-HCT: previous studies describe viral hepatitis as the most common cause of CLD. The high prevalence of MASLD in allo-HCT recipients has important implications for survivorship care.
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Affiliation(s)
- Baljit Randhawa
- Alberta Blood & Marrow Transplant Program, Tom Baker Cancer Centre, Calgary, Alberta, Canada; Division of Hematology & Hematologic Malignancies, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Nikki Blosser
- Alberta Blood & Marrow Transplant Program, Tom Baker Cancer Centre, Calgary, Alberta, Canada; Division of Hematology & Hematologic Malignancies, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Andrew Daly
- Alberta Blood & Marrow Transplant Program, Tom Baker Cancer Centre, Calgary, Alberta, Canada; Division of Hematology & Hematologic Malignancies, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Jan Storek
- Alberta Blood & Marrow Transplant Program, Tom Baker Cancer Centre, Calgary, Alberta, Canada; Division of Hematology & Hematologic Malignancies, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Abdel-Aziz Shaheen
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Kareem Jamani
- Alberta Blood & Marrow Transplant Program, Tom Baker Cancer Centre, Calgary, Alberta, Canada; Division of Hematology & Hematologic Malignancies, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
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Cornberg M, Hüppe D, Sarrazin C, Ahumada A, Jorquera Plaza F, Mariño Z, Otano JIU, Conway B, Myles L, Ramji A, Abergel A, Asselah T, Larrey D, Aghemo A, Andreoni M, Gasbarrini A, Lampertico P, Persico M, Villa E, Carmiel M, Chodick G, Weil C, Bhagat A, Bondin M, Butrymowicz I, Song Y, Semizarov D, Sonparote S, Llamas C. Updated Results from the Retrospective CREST Study on the Safety and Effectiveness of 8-Week Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis. Adv Ther 2024; 41:4669-4682. [PMID: 39470876 DOI: 10.1007/s12325-024-02996-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Accepted: 09/10/2024] [Indexed: 11/01/2024]
Abstract
INTRODUCTION This brief report presents updated findings from the previously published CREST study evaluating the safety and effectiveness of 8-week glecaprevir/pibrentasvir (GLE/PIB) in treatment-naïve patients with chronic hepatitis C virus (HCV) infection and compensated cirrhosis. The current study includes an additional 51 patients, presents effectiveness data stratified by additional comorbidities and comedications, and offers insights into healthcare resource utilization. METHODS Analysis of treatment-naïve patients with HCV infection and compensated cirrhosis enrolled in the CREST study, a real-world, observational multicenter study. All enrolled patients were included in the full analysis set (FAS); the modified analysis set (MAS) excluded patients with missing SVR12 data, or who discontinued GLE/PIB for nonvirologic failure. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12) in the MAS. Safety and healthcare resource utilization were also assessed. RESULTS The FAS included 437 patients, and the MAS 375. Overall, the results were consistent with the previously published study, with 98.9% of patients in the MAS achieving SVR12. Patients with comorbidities such as alcoholism, diabetes, and hyperlipidemia achieved SVR12 rates > 94%. High SVR12 rates were also achieved by patients receiving comedications such as anxiolytics, antidepressants, and opioid agonists. Of the 26.8% of patients with an adverse event, 1.1% had a serious adverse event, none of which were deemed related to GLE/PIB. Healthcare resource utilization varied by employment status and history of drug use. Active drug users had more physician and nurse visits than specialist visits compared with former drug users. CONCLUSION This study provides further evidence on the safety and effectiveness of 8-week GLE/PIB, supporting the use of shorter treatment in treatment-naïve patients with Child-Pugh A cirrhosis including subgroups of interest, regardless of comorbidities and comedications observed in this population. The variable healthcare resource utilization in different patient types can help plan and resource linkage to care better, thus supporting HCV elimination efforts.
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Affiliation(s)
- Markus Cornberg
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
- Centre for Individualised Infection Medicine (CiiM), Hannover, Germany.
| | - Dietrich Hüppe
- Gastroenterologische Gemeinschaftspraxis Herne, Herne, Germany
| | - Christoph Sarrazin
- Department of Internal Medicine and Liver Center, St. Josefs-Hospital Wiesbaden and Viral Hepatitis Research Group, Goethe-University Hospital Frankfurt, Frankfurt, Germany
| | - Adriana Ahumada
- Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain
| | - Francisco Jorquera Plaza
- Digestive System Service, Complejo Asistencial Universitario de León, IBIOMED and CIBERehd, León, Spain
| | - Zoe Mariño
- Hospital Clínic, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain
| | - Juan Isidro Uriz Otano
- Navarra Institute for Health Research (IdiSNA), Pamplona, Spain
- Department of Gastroenterology, Liver Unit, Complejo Hospitalario de Navarra, Pamplona, Spain
| | - Brian Conway
- Vancouver Infectious Diseases Center, Simon Fraser University, Vancouver, BC, Canada
| | | | - Alnoor Ramji
- University of British Columbia, Vancouver, BC, Canada
| | - Armand Abergel
- Département de Médecine Digestive, CHU Estaing, Clermont-Ferrand, France
| | - Tarik Asselah
- Department of Hepatology, AP-HP Hôpital Beaujon, Université de Paris, Cité CRI, INSERM UMR 1149, Clichy, France
| | - Dominique Larrey
- Service des maladies de l'appareil digestif, Hôpital Saint Eloi and IBR, INSERM, Montpellier, France
| | - Alessio Aghemo
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
- Division of Internal Medicine and Hepatology, Humanitas Research Hospital IRCCS, Rozzano, Italy
| | | | - Antonio Gasbarrini
- Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | - Pietro Lampertico
- Ospedale Maggiore Policlinico, Policlinico, Division of Gastroenterology and Hepatology, CRC 'AM and A Migliavacca' Centre for Liver Disease, Foundation IRCCS Ca' Granda, Milan, Italy
- University of Milan, Milan, Italy
| | - Marcello Persico
- Dipartimento di Medicina Clinica Medica, Epatologica e Lungodegenza, AOU OO. RR. San Giovanni di dio Ruggi e D'Aragona, Salerno, Italy
| | - Erica Villa
- UC Gastroenterologia, Dipartimento di Specialità Mediche, Azienda Ospedaliera Universitaria di Modena, Modena, Italy
| | - Michal Carmiel
- Liver Unit, Galilee Medical Center, Nahariya, Israel
- The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
| | - Gabriel Chodick
- Maccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Clara Weil
- Maccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel
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Wang J, Du L, Zhang D, Zhou C, Zeng Y, Liu M, Cheng X, Song X, Chen H, Han N, Chen E, Tang H. Real-life study on the effectiveness and safety of sofosbuvir/velpatasvir-based antiviral agents for hepatitis C eradication in Chinese patients. J Virus Erad 2024; 10:100571. [PMID: 39735164 PMCID: PMC11681871 DOI: 10.1016/j.jve.2024.100571] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Revised: 11/30/2024] [Accepted: 12/01/2024] [Indexed: 12/31/2024] Open
Abstract
Background Hepatitis C virus (HCV) eradication with sofosbuvir/velpatasvir (SOF/VEL) represents a significant advancement, offering hope for eliminating the virus in diverse patient populations. But real-world data on its effectiveness and safety remains scarce for patients with chronic hepatitis C (CHC) in China, especially those with HCV GT3b, cirrhosis, hepato-cellular carcinoma (HCC), or HCV/hepatitis B (HBV), HCV/HIV, or HCV/HBV/HIV coinfection. Methods In this real-world prospective observational study, we recruited patients from the West China Hospital and Public Health Clinical Center of Chengdu in China. Patients included adults with with CHC and any genotype (GT), with or without cirrhosis, hepatocellular carcinoma (HCC), HCV/HBV, HCV/HIV, or HCV/HBV/HIV coinfection. Patients were administered SOF/VEL (400/100 mg) ± ribavirin (RBV) once daily for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12). Adverse events (AEs) were evaluated during treatment. Results The study included 483 patients with HCV genotypes 1, 2, 3, 6 and uncertain ones. Among them, 35.4 % (171/483, ITT) and 36.7 % (166/452, mITT) received SOF/VEL + RBV. At the end of treatment , 99.2 % (ITT, 479/483) and 99.1 % (mITT, 448/452) of patients had undetectable HCV RNA. SVR12 rates were 92.8 % [intention to treat (ITT), 448/483] and 99.1 % [modified ITT (mITT), 448/452]. In the mITT analysis, SVR12 for patients with HCV GT3b, those with cirrhosis or HCC, and those coinfected with HBV/HIV was 99.2 % (130/131), 99.4 % (168/169), and 97.6 % (40/41), respectively. The albumin-bilirubin (ALBI) (-3.01 vs. -3.18 P < 0.001), Fibrosis-4 (FIB4) Index (2.53 vs. 1.88, P = 0.004) and AST to Platelet Ratio Index (APRI) (0.99 vs. 0.44, P < 0.001) scores showed a significant decrease from baseline to SVR12. No patients experienced grade 3-5 AEs. Conclusions Although a high proportion of patients included in this study had HCV GT3b, cirrhosis, HCC, or HCV/HBV, HCV/HIV, or HCV/HBV/HIV coinfection, SOF/VEL ± RBV was highly effective and well tolerated in Chinese patients with CHC.
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Affiliation(s)
- Jiayi Wang
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Lingyao Du
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Dongmei Zhang
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Chen Zhou
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Yilan Zeng
- Public Health Clinical Center of Chengdu, Chengdu, Sichuan, 610041, China
| | - Miao Liu
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Xing Cheng
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Xiaona Song
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Han Chen
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Ning Han
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Enqiang Chen
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
| | - Hong Tang
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
- Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China
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