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1
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Rajpurohit S, Musunuri B, Mohan PB, Bhat G, Shetty S. Health-related Quality of Life in Patients With Liver Cirrhosis: A Randomized Study. J Clin Exp Hepatol 2024; 14:101433. [PMID: 38873593 PMCID: PMC11166871 DOI: 10.1016/j.jceh.2024.101433] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2024] [Accepted: 04/19/2024] [Indexed: 06/15/2024] Open
Abstract
Background/Aims Health-related quality of life (HRQoL) relates to how people perceive illness and treatment affects their physical health, emotional health, functional status, and social position. Along with clinical goals, HRQoL is significant. Therefore, the present study evaluates the effect of patient counseling and education on HRQoL of cirrhotic patients. Methods This prospective study was conducted in a tertiary care center of coastal Karnataka, Kasturba Medical College, Manipal, Karnataka from October 2022 with a three-month follow-up. Patients with a confirmed diagnosis of liver cirrhosis visiting the outpatient department of age ≥18 were enrolled in the study and divided on the basis of compensated and decompensated cirrhosis. Patients were randomized into two groups i.e., case and control in compensated and decompensated group through the envelop method of randomization. The case group received patient education and counseling along with standard medical therapy. CLDQ was used to evaluate HRQoL scores on baseline and after the third month. Results A total of 104 patients were enrolled with a mean age of 53.49 ± 11.25, with most being male (80.7%). Out of 104, 60 and 44 had compensated and decompensated cirrhosis. Case and control groups did not differ significantly on baseline. However, on follow-up, the compensated group showed significant improvement in abdominal symptoms, fatigue, and emotional functions. Meanwhile, the decompensated group showed significant improvement in activity, emotional function, and worry domain of CLDQ. Higher MELD scores were the significant factor associated with lower HRQoL scores. Conclusion Patient education and counseling positively impacted the fatigue, emotional, and worry domain of the CLDQ. Hence, the present study recommends making an effort to promote patient counseling and education via leaflets or videos.
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Affiliation(s)
- Siddheesh Rajpurohit
- Department of Gastroenterology & Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
| | - Balaji Musunuri
- Department of Gastroenterology & Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
| | - Pooja B. Mohan
- Department of Gastroenterology & Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
| | - Ganesh Bhat
- Department of Gastroenterology & Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
| | - Shiran Shetty
- Department of Gastroenterology & Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India
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Peña-Longobardo LM, Oliva-Moreno J, Fernández-Rodriguez C. The effect of hepatitis C-associated premature deaths on labour productivity losses in Spain: a ten-year analysis. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2023; 24:1271-1283. [PMID: 36352296 PMCID: PMC9646468 DOI: 10.1007/s10198-022-01540-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/08/2021] [Accepted: 10/11/2022] [Indexed: 06/16/2023]
Abstract
Hepatitis C virus (HCV) infection causes a substantial economic burden, not only in terms of healthcare costs, but also in labour productivity losses. The main objective of this study is to provide objective and comparable information about the trend in labour productivity losses caused by premature HCV-associated deaths in Spain in recent years (2009-2018). We used nationwide data from several official sources to create a simulation model based on the human capital approach and to estimate the flows in labour productivity losses due to deaths identified in the period considered. Based on a pessimistic scenario, the annual number of deaths due to HCV infections decreased by 19.7% between 2009 and 2018. The years of potential labour productive life lost (YPLPLL) decreased by 38.1%. That reduction led to a decrease in annual labour productivity losses from €236 million in 2009 to €156 million in 2018 (-33.8%). The aggregate HCV-related labour productivity losses between 2009 and 2018 ranged from €1742 million (optimistic scenario) to €1949 million (pessimistic scenario), with an intermediate estimation of €1846 million (moderately optimistic scenario). These results show a substantial reduction in annual deaths, working-age deaths, YPLPLL, and labour productivity losses associated with HCV infection over this period.
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Affiliation(s)
- L M Peña-Longobardo
- Department of Economic Analysis and Finance and Seminar on Economics and Health, Universidad de Castilla-La Mancha, Toledo, Spain
| | - J Oliva-Moreno
- Department of Economic Analysis and Finance and Seminar on Economics and Health, Universidad de Castilla-La Mancha, Toledo, Spain.
| | - C Fernández-Rodriguez
- Service of Gastroenterology, Fundación Alcorcón University Hospital, University Rey Juan Carlos, Madrid, Spain
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3
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Agosti-Gonzalez R, Falcato L, Grischott T, Senn O, Bruggmann P. Hepatitis C antibody test frequencies and positive rates in Switzerland from 2007 to 2017: a retrospective longitudinal study. Swiss Med Wkly 2023; 153:40085. [PMID: 37410941 DOI: 10.57187/smw.2023.40085] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/08/2023] Open
Abstract
ACKGROUND AND AIMS The prevalence of chronic hepatitis C in Switzerland is currently estimated at approximately 32,000 affected individuals (0.37% of the permanent resident population). An estimated 40% of affected individuals in Switzerland is undiagnosed. The Swiss Federal Office of Public Health requires laboratories to report all positive hepatitis C virus (HCV) test results. Approximately 900 newly diagnosed cases are reported annually. The number of HCV tests performed, however, is not collected by the Federal Office of Public Health and positive rates are therefore unknown. The aim of this study was to describe the longitudinal course of the numbers of hepatitis C antibody tests and of positive rates in Switzerland for the years 2007 to 2017. METHODS Twenty laboratories were asked to provide the number of HCV antibody tests performed and the number of positive antibody tests per year. Using data from the Federal Office of Public Health reporting system for the years 2012 to 2017, we calculated a factor to correct our values for multiple tests of the same person. RESULTS The annual number of HCV antibody tests performed tripled linearly from 2007 to 2017 (from 42,105 to 121,266) while the number of positive HCV antibody test results increased by only 75% over the same period (from 1360 to 2379). The HCV antibody test positive rate steadily decreased from 3.2% in 2007 to 2.0% in 2017. After correction for multiple tests per person, the person-level HCV antibody tested positive rate decreased from 2.2% to 1.7% from 2012 to 2017. CONCLUSION In the Swiss laboratories considered, more HCV antibody tests were performed each year in the period (2007-2017) before and during the approval of the new hepatitis C drugs. At the same time, the HCV antibody positive rates decreased, both on a per-test as well as a per-person level. This study is the first to describe the evolution of tests performed and of positive rates for HCV antibody in Switzerland at the national level over several years. In order to more accurately guide future measures to achieve the goal of eliminating hepatitis C by 2030, we recommend annual collection and publication of positive rates by health authorities, along with mandatory reporting of numbers of tests and people treated.
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Affiliation(s)
| | - Luis Falcato
- Arud Centre for Addiction Medicine, Zurich, Switzerland
| | - Thomas Grischott
- Institute of Primary Care, University Hospital Zurich, University of Zurich, Switzerland
| | - Oliver Senn
- Institute of Primary Care, University Hospital Zurich, University of Zurich, Switzerland
| | - Philip Bruggmann
- Arud Centre for Addiction Medicine, Zurich, Switzerland
- Institute of Primary Care, University Hospital Zurich, University of Zurich, Switzerland
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Carty PG, Teljeur C, De Gascun CF, Gillespie P, Harrington P, McCormick A, O'Neill M, Smith SM, Ryan M. Another Step Toward Hepatitis C Elimination: An Economic Evaluation of an Irish National Birth Cohort Testing Program. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2022; 25:1947-1957. [PMID: 35778325 DOI: 10.1016/j.jval.2022.05.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/21/2021] [Revised: 04/14/2022] [Accepted: 05/05/2022] [Indexed: 06/15/2023]
Abstract
OBJECTIVES We aimed to evaluate the cost-effectiveness of offering once-off birth cohort testing for hepatitis C virus (HCV) to people in Ireland born between 1965 and 1985, the cohort with the highest reported prevalence of undiagnosed chronic HCV infection. METHODS Systematic and opportunistic HCV birth cohort testing programs, implemented over a 4-year timeframe, were compared with the current practice of population risk-based testing only in a closed-cohort decision tree and Markov model hybrid over a lifetime time horizon. Outcomes were expressed in quality-adjusted life-years (QALYs). Costs were presented from the health system's perspective in 2020 euro (€). Uncertainty was assessed via deterministic, probabilistic, scenario, and threshold analyses. RESULTS In the base case, systematic testing yielded the largest cost and health benefits, followed by opportunistic testing and risk-based testing. Compared with risk-based testing, the incremental cost-effectiveness ratio for opportunistic testing was €14 586 (95% confidence interval €4185-€33 527) per QALY gained. Compared with opportunistic testing, the incremental cost-effectiveness ratio for systematic testing was €16 827 (95% confidence interval €5106-€38 843) per QALY gained. These findings were robust across a range of sensitivity analyses. CONCLUSIONS Both systematic and opportunistic birth cohort testing would be considered an efficient use of resources, but systematic testing was the optimal strategy at willingness-to-pay threshold values typically used in Ireland. Although cost-effective, any decision to introduce birth cohort testing for HCV (in Ireland or elsewhere) must be balanced with considerations regarding the feasibility and budget impact of implementing a national testing program given high initial costs and resource use.
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Affiliation(s)
- Paul G Carty
- RCSI University of Medicine and Health Sciences, Dublin, Ireland; Health Information and Quality Authority, Dublin, Ireland.
| | - Conor Teljeur
- Health Information and Quality Authority, Dublin, Ireland
| | - Cillian F De Gascun
- National Virus Reference Laboratory, University College Dublin, Dublin, Ireland
| | - Paddy Gillespie
- Health Economics & Policy Analysis Centre, National University of Ireland Galway, Galway, Ireland; CÚRAM, The SFI Research Centre for Medical Devices (12/RC/2073_2), National University of Ireland Galway, Galway, Ireland
| | | | | | | | - Susan M Smith
- Department of Public Health and Primary Care, School of Medicine, Trinity College Dublin, Ireland
| | - Mairin Ryan
- Health Information and Quality Authority, Dublin, Ireland; Department of Pharmacology and Therapeutics, Trinity College Dublin, Trinity Health Sciences, St James's Hospital, Dublin, Ireland
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Romagnoli D. Elimination of hepatitis C virus infection in Europe: targeting the obstacles. EXPLORATION OF MEDICINE 2022:71-76. [DOI: 10.37349/emed.2022.00075] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/23/2021] [Accepted: 12/29/2021] [Indexed: 01/03/2025] Open
Affiliation(s)
- Dante Romagnoli
- Gastroenterology Unit, Polyclinic, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy
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Carty PG, McCarthy M, O'Neill SM, De Gascun CF, Harrington P, O'Neill M, Smith SM, Teljeur C, Ryan M. Laboratory-based testing for hepatitis C infection using dried blood spot samples: A systematic review and meta-analysis of diagnostic accuracy. Rev Med Virol 2021; 32:e2320. [PMID: 34957630 DOI: 10.1002/rmv.2320] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2021] [Revised: 12/11/2021] [Accepted: 12/13/2021] [Indexed: 11/10/2022]
Abstract
The use of dried blood spot (DBS) samples can facilitate the implementation of reflex testing by circumventing the need for centrifugation and freezing of venous blood samples. This systematic review assessed the accuracy of using DBS samples to diagnose chronic hepatitis C virus (HCV) infection. A comprehensive search was undertaken to identify articles published up to July 2020 evaluating the diagnostic accuracy of anti-HCV, HCV-RNA and HCV core antigen tests using DBS. Screening, data extraction, quality appraisal and Grading of Recommendations, Assessment, Development and Evaluations certainty of the evidence assessment were performed independently by two reviewers. Meta-analysis, meta-regression and sensitivity analyses were conducted. The evidence demonstrates that laboratory-based anti-HCV and HCV-RNA tests using DBS samples have high diagnostic accuracy. All comparisons were between DBS and venous samples. For the detection of anti-HCV, sensitivity was 95% (95% CI: 92%-97%) and specificity was 99% ([95% CI: 98%-99%]; n = 25; I2 = 81%; moderate certainty). For the detection of HCV-RNA, the sensitivity was 95% (95% CI: 93%-97%) and specificity was 97% ([95% CI: 94%-98%]; n = 20; I2 = 52%; moderate certainty). The sensitivity of HCV core antigen tests was 86% (95% CI: 79%-91%) and specificity was 98% ([95% CI: 94%-99%]; n = 5; I2 = 37%; low certainty) compared with HCV-RNA (the gold standard for detecting chronic HCV). DBS samples could facilitate diagnosis of chronic HCV infection as the necessary sequential tests (anti-HCV and then HCV-RNA or HCV core antigen) can be undertaken using the same blood sample. This could reduce loss of patient follow-up and support international efforts towards HCV elimination in both high and low prevalence settings.
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Affiliation(s)
- Paul G Carty
- Faculty of Medicine & Health Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.,Health Information and Quality Authority, Dublin, Ireland
| | | | | | - Cillian F De Gascun
- National Virus Reference Laboratory, University College Dublin, Dublin, Ireland
| | | | | | - Susan M Smith
- Department of General Practice, Health Research Board Centre for Primary Care Research, Royal College of Surgeons in Ireland, Dublin, Ireland
| | - Conor Teljeur
- Health Information and Quality Authority, Dublin, Ireland
| | - Mairin Ryan
- Health Information and Quality Authority, Dublin, Ireland.,Department of Pharmacology & Therapeutics, Trinity College Dublin, Trinity Health Sciences, St James's Hospital, Dublin, Ireland
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Beykaso G, Mulu A, Giday M, Berhe N, Selamu M, Mihret A, Teklehaymanot T. Burden and Transmission Risks of Viral Hepatitis in Southern Ethiopia: Evidence Needed for Prevention and Control Measures. Risk Manag Healthc Policy 2021; 14:4843-4852. [PMID: 34880693 PMCID: PMC8646867 DOI: 10.2147/rmhp.s336776] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2021] [Accepted: 11/13/2021] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND Hepatitis B virus (HBV) and hepatitis C virus (HCV) are significant causes of liver-associated morbidity and mortality for millions of people globally. Ethiopia is one of the viral hepatitis-endemic countries with no national strategy for surveillance and limited data. As such, this study aimed to investigated the extent and associated risk factors of HBV and HCV among community members in southern Ethiopia. METHODS A community-based cross-sectional study was conducted from January 2020 to August 2020. A structured questionnaire was used to collect behavioral and sociodemographic data. Serum samples were collected and assayed for seromarkers of HBV (HBsAg, anti-HBc, and anti-HBs) and HCV (anti-HCV) using ELISAs. In HBsAg-positive samples, HBV DNA was further quantified using RT-PCR. Data were entered into EpiData 3.1 and analyzed using SPSS 21.0. Descriptive statistics and logistic regression analysis were employed. RESULTS The study included 693 participants. Seromarkers for HBsAg, anti-HCV, anti-HBc, and anti-HBs were found to be 9.5%, 1.4%, 31.1%, and 14.3%, respectively. In 66 HBsAg positives, 57 (86.4%) had quantifiable HBV DNA. Prevalence of current HBV infection (HBsAg+, anti-HBc+, anti-HBs-) and lifetime exposure (positive for either HBsAg or anti-HBc) to HBV were 8.7% and 31.9%, respectively, and 63.1% of participants were vulnerable or had no evidence of prior HBV infection (HBsAg-, anti-HBc-, anti-HBs-). On multivariate logistic regression analysis, multiple sexual contacts, family history of hepatitis infection, alcohol consumption, and khat chewing were significantly associated with HBV. The seroprevalence of HBV was relatively high in this study area. CONCLUSION This study showed high prevalence of HBV infection, but low prevalence of HCV. This indicates that HBV is a major health problem in this community. Population-based surveillance, care, and treatment, as well as behavioral change and education programs, should be enhanced to minimize risk exposure.
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Affiliation(s)
- Gizachew Beykaso
- Department of Molecular Biology and Immunology, Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia
- Department of Public Health, College of Medicine and Health Sciences, Wachemo University, Hossana, Ethiopia
| | - Andargachew Mulu
- Department of Virology, Armauer Hansen Research Institute, Addis Ababa, Ethiopia
| | - Mirutse Giday
- Department of Molecular Biology and Immunology, Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia
| | - Nega Berhe
- Department of Molecular Biology and Immunology, Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia
| | - Markos Selamu
- Department of Public Health, College of Medicine and Health Sciences, Wachemo University, Hossana, Ethiopia
| | - Adane Mihret
- Department of Virology, Armauer Hansen Research Institute, Addis Ababa, Ethiopia
| | - Tilahun Teklehaymanot
- Department of Molecular Biology and Immunology, Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia
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Mennini FS, Marcellusi A, Robbins Scott S, Montilla S, Craxi A, Buti M, Gheorghe L, Ryder S, Kondili LA. The impact of direct acting antivirals on hepatitis C virus disease burden and associated costs in four european countries. Liver Int 2021; 41:934-948. [PMID: 33529499 PMCID: PMC8248004 DOI: 10.1111/liv.14808] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Revised: 01/21/2021] [Accepted: 01/24/2021] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS We assessed the clinical and economic impact of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) in England, Italy, Romania and Spain. METHODS An HCV progression Markov model was developed considering DAA eligibility and population data during the years 2015-2019. The period of time to recover the investment in DAAs was calculated as the cost saved by avoiding estimated clinical events for 1000 standardized treated patients. A delayed treatment scenario because of coronavirus disease (COVID-19) was also developed. RESULTS The estimated number of avoided hepatocellular carcinoma, decompensated cirrhosis and liver transplantations over a 20-year time horizon was: 1,057 in England; 1,221 in Italy; 1,211 in Romania; and 1,103 in Spain for patients treated during 2015-2016 and 640 in England; 626 in Italy; 739 in Romania; and 643 in Spain for patients treated during 2017-2019. The cost-savings ranged from € 45 to € 275 million. The investment needed to expand access to DAAs in 2015-2019 is estimated to be recovered in 6.5 years in England; 5.4 years in Italy; 6.7 years in Romania; and 4.5 years in Spain. A delay in treatment because of COVID-19 will increase liver mortality in all countries. CONCLUSION Direct-acting antivirals have significant clinical benefits and can bring substantial cost-savings over the next 20 years, reaching a Break-even point in a short period of time. When pursuing an exit strategy from strict lockdown measures for COVID-19, providing DAAs should remain high on the list of priorities in order to maintain HCV elimination efforts.
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Affiliation(s)
- Francesco S. Mennini
- Economic Evaluation and HTACentre for Economic and International Studies(EEHTA‐CEIS) Faculty of EconomicsUniversity of Rome “Tor Vergata”RomeItaly
- Institute of Leadership and Management in HealthKingston Business SchoolKingston UniveristyLondonUK
| | - Andrea Marcellusi
- Economic Evaluation and HTACentre for Economic and International Studies(EEHTA‐CEIS) Faculty of EconomicsUniversity of Rome “Tor Vergata”RomeItaly
- Institute of Leadership and Management in HealthKingston Business SchoolKingston UniveristyLondonUK
| | - Sarah Robbins Scott
- Economic Evaluation and HTACentre for Economic and International Studies(EEHTA‐CEIS) Faculty of EconomicsUniversity of Rome “Tor Vergata”RomeItaly
| | - Simona Montilla
- Department of Economic Strategy of Pharmaceutical ProductsItalian Medicines AgencyRomeItaly
| | - Antonio Craxi
- Gastroenterology and Hepatology UnitDepartment of Internal Medicine and Medical Specialties "PROMISE"University of PalermoPalermoItaly
| | - Maria Buti
- Liver UnitHospital Universitario Valle Hebron and CIBER‐EHD del Insitituto Carlos IIIBarcelonaSpain
| | - Liana Gheorghe
- Center for Digestive Diseases and Liver TransplantationFundeni Clinical InstituteUniversity of Medicine and Pharmacy Carol DavilaBucharestRomania
| | - Stephen Ryder
- NIHR Nottingham Biomedical Research CentreNottingham University Hospitals NHS TrustThe University of NottinghamNottinghamUK
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Change in γ-glutamyl transpeptidase activity as a useful tool in identifying a group of patients with elevated risk of hepatocellular carcinoma development after DAA treatment of chronic hepatitis C. Clin Exp Hepatol 2021; 7:93-100. [PMID: 34027121 PMCID: PMC8122098 DOI: 10.5114/ceh.2021.104466] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Accepted: 12/16/2020] [Indexed: 12/30/2022] Open
Abstract
Aim of the study Hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) incidence will be diminishing due to use of direct acting antiviral agents (DAA), but there is still constant risk for HCC development. Elevated serum g-glutamyl transpeptidase (GGT) activity is associated with increased risk of liver cancer. In our study we tried to determine whether change in GGT activity may be useful in identifying patients with elevated risk of HCC development after DAA treatment. Material and methods The study population consisted of 111 patients with chronic hepatitis C (CHC) treated with DAA. Laboratory tests [alanine aminotransferase (ALT), GGT, a-fetoprotein (AFP)] and liver stiffness measurement (using FibroScan) were performed at the beginning and at the end of therapy. Results Pre-treatment ALT activity, GGT activity and AFP concentration in patients with CHC were directly associated with the stage of liver fibrosis. Elimination of HCV after DAA treatment caused significant reduction in serum GGT activity and was not associated with pre-treatment liver fibrosis. AFP concentration was significantly lower after treatment. It was observed regardless of pre-treatment AFP concentration, but the largest reduction was demonstrated in the group of patients with advanced fibrosis. In multivariate analysis there was no significant difference in GGT activity after treatment only in patients with pre-treatment normal AFP concentration and advanced liver fibrosis. Conclusions Patients who after achieving a sustained virological response (SVR) did not lower both AFP concentration and GGT activity may have higher risk of HCC development. Special monitoring may be required in patients with advanced liver fibrosis and normal AFP concentration before treatment.
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Hashempour T, Dehghani B, Mousavi Z, Akbari T, Hasanshahi Z, Moayedi J, Yahaghi M, Davarpanah MA. Association of Mutations in the NS5A-PKRBD Region and IFNL4 Genotypes with Hepatitis C Interferon Responsiveness and its Functional and Structural Analysis. CURR PROTEOMICS 2021. [DOI: 10.2174/1570164617666200107091124] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Background:
The cellular antiviral responses induced by interferons require some cellular
protein kinase for its activation. Evidence indicated that a number of Hepatitis C Virus (HCV) proteins
can repress double-stranded (ds) RNA-dependent Protein Kinase (PKR) function and help HCV to escape.
However, the reports are controversial, some researchers have suggested that a region in Nonstructural
5A (NS5A) gene called Protein Kinase R-Binding Domain (PKR-BD) is associated with HCV sensitivity
to the antiviral effects of Interferon (IFN). In addition, the other factor that might be associated
with response to PEGylated-IFNα (Peg-IFNα) and Ribavirin (RBV) combination therapy, is IFNL4
genotypes.
Objective:
The aim of this study was to investigate the association between amino acid (aa) substitutions
in the NS5A region and the IFNL4 genotypes in two Single Nucleotide Polymorphism (SNP)
(rs8099917. rs12979860) in patients with HCV genotypes 1a and 3a. We also examined their response
to combination therapy and the effect of these mutations on the function and structure of PKR-BD.
Methods:
Eighty-six patients with hepatitis C were recruited and follow-up for 6 months. Several tests,
including alanine aminotransferase (ALT), aspartate aminotransferase (AST), viral load, IFNL4 genotyping,
and PKR-BD sequencing were performed. Using several well-known and trustworthy bioinformatics
tools, sequences were analyzed to define physio-chemical properties, structural features, immune
epitopes and protein-protein interaction.
Results:
Of the 86 patients, 65.1% had high viral load at baseline, 64% had CT genotype for rs12979860
and 57% had GT genotype for rs8099917. Several aa residues changes were found in the PKR-BD region.
We could not find any link between mutations in the PKR-BD region and different genotypes of IFNL4
in response to antiviral therapy. Regardless of pI, PKR-BD 1a and 3a showed similar physio-chemical
properties, and 2 phosphorylation sites and one glycosylation site were estimated for both PKR-BD 1a
and 3a. Trustworthy software were employed in order to predict B-cell epitopes, 3 regions (6-17, 26-32,
34-41) were found for both proteins, indicating a huge potential of PKR-BD protein to induce humoral
immune system. Docking analysis determined non-responder sequences in both 1a and 3a genotypes
to have higher energy value and are more compatible with PKR.
Conclusion:
To sum up, our results could not determine any significant relationship between mutations
of PKR-BD and genotypes of IFNL4 with other factors; ALT, AST, viral load. However, docking results
showed strengthened interaction between PKR-BD and PKR in non-responders that could have a
momentous impact on the illness severity.
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Affiliation(s)
- Tayebeh Hashempour
- Clinical Microbiology Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Behzad Dehghani
- Clinical Microbiology Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Zahra Mousavi
- Clinical Microbiology Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Tahereh Akbari
- Gastroenterohepatology Research Center, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
| | - Zahra Hasanshahi
- Clinical Microbiology Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Javad Moayedi
- Clinical Microbiology Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Maryam Yahaghi
- Gastroenterohepatology Research Center, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
| | - Mohammad Ali Davarpanah
- Gastroenterohepatology Research Center, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
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Wiessing L, Giraudon I, Duffell E, Veldhuijzen I, Zimmermann R, Hope V. Epidemiology of Hepatitis C Virus: People Who Inject Drugs and Other Key Populations. HEPATITIS C: EPIDEMIOLOGY, PREVENTION AND ELIMINATION 2021:109-149. [DOI: 10.1007/978-3-030-64649-3_6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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Gonzalez-Serna A, Macias J, Palacios R, Gómez-Ayerbe C, Tellez F, Rivero-Juárez A, Fernandez M, Santos J, Real LM, Gonzalez-Domenech CM, Gomez-Mateos J, Pineda JA. Incidence of recently acquired hepatitis C virus infection among HIV-infected patients in southern Spain. HIV Med 2020; 22:379-386. [PMID: 33369104 DOI: 10.1111/hiv.13039] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2020] [Revised: 11/20/2020] [Accepted: 11/26/2020] [Indexed: 12/13/2022]
Abstract
OBJECTIVES Spain is close to HCV microelimination, so rates of recently acquired HCV infection (RAHC) should decrease. Nowadays, men who have sex with men (MSM) carry the highest risk of HCV acquisition. Our aim was to estimate the incidence of and the factors associated with RAHC, together with reinfection rates, among patients sexually infected by HIV. METHODS Primary RAHC infection was diagnosed when anti-HCV antibody seroconversion was documented. In anti-HCV positive patients, initially without HCV viraemia, a diagnosis of reinfection was established if plasma HCV RNA was detected. RESULTS All 350 patients tested negative for anti-HCV at baseline and had at least one follow-up visit. Among them, there were 16 RAHC cases from 2016 to 2019. RAHC incidence rates [IR (95% confidence interval, CI)] per 100 person-years were 3.77 (0.5-12.9) in 2016, 1.85 (0.6-4.3) in 2017, 1.49 (0.4-3.8) in 2018 and 1.98 (0.6-4.5) in 2019. Only previous sexually transmitted infections [incidence rate ratio (IRR) = 18.23, 95% CI: 1.93-172.1; P = 0.011], male sex (IRR = 8.33, 95% CI: 1.38-54.15; P = 0.026) and sharing chem-sex drugs (IRR: 4.93, 95% CI: 1.17-20.76; P = 0.030), were independently associated with RAHC. Four out of 42 (9.5%) patients became reinfected. CONCLUSIONS The incidence of RAHC among HIV-infected patients showed a decrease after 2016, although a lower but steady incidence of residual cases still remains. HCV reinfections showed a similar pattern. New infections were associated with sharing chem-sex drugs among MSM.
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Affiliation(s)
- A Gonzalez-Serna
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
| | - J Macias
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
| | - R Palacios
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de la Victoria, Málaga, Spain
| | - C Gómez-Ayerbe
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de la Victoria, Málaga, Spain
| | - F Tellez
- UGC Enfermedades Infecciosas, Departamento Medicina, Universidad de Cádiz, Hospital Universitario de Puerto Real, Cádiz, Spain
| | - A Rivero-Juárez
- Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, Spain
| | - M Fernandez
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
| | - J Santos
- Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, Spain
| | - L M Real
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
| | - C M Gonzalez-Domenech
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de la Victoria, Málaga, Spain
| | - J Gomez-Mateos
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
| | - J A Pineda
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Sevilla, Spain
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13
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Leventer-Roberts M, Dagan N, Berent JM, Brufman I, Hoshen M, Braun M, Balicer RD, Feldman BS. Using population-level incidence of hepatitis C virus and immigration status for data-driven screening policies: a case study in Israel. J Public Health (Oxf) 2020; 44:2-9. [PMID: 33348364 DOI: 10.1093/pubmed/fdaa215] [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: 11/06/2019] [Revised: 10/01/2020] [Accepted: 10/30/2020] [Indexed: 11/12/2022] Open
Abstract
BACKGROUND Most studies estimate hepatitis C virus (HCV) disease prevalence from convenience samples. Consequently, screening policies may not include those at the highest risk for a new diagnosis. METHODS Clalit Health Services members aged 25-74 as of 31 December 2009 were included in the study. Rates of testing and new diagnoses of HCV were calculated, and potential risk groups were examined. RESULTS Of the 2 029 501 included members, those aged 45-54 and immigrants had lower rates of testing (12.5% and 15.6%, respectively), higher rates of testing positive (0.8% and 1.1%, respectively), as well as the highest rates of testing positive among tested (6.1% and 6.9%, respectively). DISCUSSION In this population-level study, groups more likely to test positive for HCV also had lower rates of testing. Policy makers and clinicians worldwide should consider creating screening policies using on population-based data to maximize the ability to detect and treat incident cases.
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Affiliation(s)
- Maya Leventer-Roberts
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel.,Departments of Pediatrics, Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | - Noa Dagan
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel.,Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA
| | - Jenna M Berent
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel.,Clalit Health Services, Tel Aviv 6209804, Israel
| | - Ilan Brufman
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel
| | - Moshe Hoshen
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel
| | - Marius Braun
- Liver Institute, Rabin Medical Center, Beilinson Hospital, Petah Tiqwa 49100, Israel
| | - Ran D Balicer
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel.,Clalit Health Services, Tel Aviv 6209804, Israel.,Epidemiology Department, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, 8410501, Israel
| | - Becca S Feldman
- Clalit Research Institute, Clalit Health Services, Tel Aviv 6209804, Israel
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14
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Chronic hepatitis C virus infection in the Czech Republic and Slovakia: an analysis of patient and virus characteristics. Int J Public Health 2020; 65:1723-1735. [PMID: 33040165 DOI: 10.1007/s00038-020-01496-y] [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: 04/14/2020] [Revised: 09/18/2020] [Accepted: 09/22/2020] [Indexed: 10/23/2022] Open
Abstract
OBJECTIVES The MOSAIC study gathered data on chronic hepatitis C virus (HCV) infection and its treatment in various countries worldwide. Here we summarise patient and HCV characteristics in the Czech Republic and Slovakia. METHODS MOSAIC was an observational study that included patients with chronic HCV infection untreated at the time of enrolment. Study collected and descriptively analysed patient demographics, disease stage and viral characteristics. Data were collected between February 2014 to October 2014. RESULTS Among 220 patients enrolled, 51.4% were treatment-naïve. The most prevalent HCV genotype was G1 (78.4%), followed by G3 (19.7%). Higher prevalence of G1 was found in treatment-experienced patients (94.3%) compared to treatment-naïve (63.4%). Most participants (67.7%) presented viral RNA load of ≥ 800,000 IU/mL. Liver cirrhosis was reported in 24.5% of patients. Higher HCV RNA load and duration of HCV infection correlated with the degree of liver fibrosis. Anti-HCV interferon-based treatments were initiated in 88.2% of participants. CONCLUSIONS The study confirmed significant changes in the HCV genotypes partition with G3 genotype rapidly increasing in both countries, with possible impact on the WHO eradication initiative and treatment selection.
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15
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Golrokh Mofrad M, Taghizadeh Maleki D, Faghihloo E. The roles of programmed death ligand 1 in virus-associated cancers. INFECTION GENETICS AND EVOLUTION 2020; 84:104368. [DOI: 10.1016/j.meegid.2020.104368] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/19/2019] [Revised: 04/08/2020] [Accepted: 05/14/2020] [Indexed: 12/12/2022]
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16
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Calleja Panero JL, Lens García S, Fernández Bermejo M, Crespo J. Definition of the profiles of hepatitis C virus patients based on the identification of risky practices in Spain. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2020; 111:731-737. [PMID: 31526012 DOI: 10.17235/reed.2019.6169/2019] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
The absolute number of patients infected with the hepatitis C virus and its prevalence in Spain according to risk practices are not precise. The objective of the study was to estimate the current direct-action antiviral candidates, according to risky practices. The exposed population was determined according to each risky practice and age, based on the data obtained in two epidemiological studies and other bibliographic sources. The overall prevalence of positive serology for the Hepatitis C virus according to the analyzed data was 1.1% (41% with an active infection). The most at-risk group are intravenous drug users (60,368-82,454). It is estimated that between 37,387 to 51,065 patients would be infected via sexual transmission, between 55,505 and 75,812 patients following a blood transfusion and around 18,528 to 25,307 patients by socio-family transmission. According to these data, more than half (55-79%) of the subjects with risky practices would have significant fibrosis (≥ F2). It is estimated that more than half a million people have a positive serology for the Hepatitis C virus and 144,191 to 227,773 antiviral treatments are expected in the coming years. The identification of people with risky practices is key to increase the percentage of diagnosed cases.
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Affiliation(s)
| | | | | | - Javier Crespo
- Servicio de Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Santander., España
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17
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Mukhtar NA, Ness EM, Jhaveri M, Fix OK, Hart M, Dale C, Pratt C, Kowdley KV. Epidemiologic features of a large hepatitis C cohort evaluated in a major health system in the western United States. Ann Hepatol 2020; 18:360-365. [PMID: 31053542 DOI: 10.1016/j.aohep.2018.12.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/11/2018] [Revised: 12/10/2018] [Accepted: 12/10/2018] [Indexed: 02/04/2023]
Abstract
INTRODUCTION AND AIM Real-world epidemiologic data to guide hepatitis C virus (HCV)-related public health initiatives are lacking. The aim of this study was to describe the prevalence and epidemiological characteristics of a large cohort of patients with an HCV diagnosis evaluated in one of the largest health systems in the United States. MATERIALS AND METHODS De-identified demographic and clinical data were extracted from the electronic health record for patients actively followed within the Providence Health & Services health care system. Rates of HCV prevalence and co-morbid illnesses among HCV-infected patients were determined. RESULTS Among 2,735,511 active patients, 23,492 (0.86%) were found to have evidence of HCV infection, the majority of which were Caucasian (78.2%) and born between the years 1945 and 1965 (68.3%). In comparison to Caucasians, higher rates of HCV infection were found among Native Americans (2.5% vs. 0.95%, p<0.001). Compared to HCV-negative patients, a greater proportion of HCV-positive patients had diabetes mellitus (18.7 vs. 8.9%, p<0.0001), chronic kidney disease (4.4 vs. 1.8%, p<0.0001), end-stage renal disease necessitating hemodialysis (2.6 vs. 0.6%, p<0.0001), and HIV co-infection (2.4 vs. 0.2, p<0.0001). Nearly two-thirds (62.1%) of HCV patients had government-sponsored insurance, and 93.0% of treated patients resided in urban settings. CONCLUSION The prevalence of HCV infection in this large health care system serving the Pacific Northwest, Alaska, and California was lower than prior population-based estimates and may reflect real-world prevalence rates among patients not selected for risk-based screening. Native Americans are disproportionately affected by HCV and may warrant targeted screening.
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Affiliation(s)
- Nizar A Mukhtar
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | - Erik M Ness
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | - Manan Jhaveri
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | - Oren K Fix
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | - Marquis Hart
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | - Christopher Dale
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA
| | | | - Kris V Kowdley
- Liver Care Network and Organ Transplant Program, Swedish Medical Center, Seattle, WA, USA; Providence Health & Services, Renton, WA, USA.
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18
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Crespo J, Cuadrado A, Perelló C, Cabezas J, Llerena S, Llorca J, Cedillo S, Llop E, Escudero MD, Hernández Conde M, Puchades L, Redondo C, Fortea JI, Gil de Miguel A, Serra MA, Lazarus JV, Calleja JL. Epidemiology of hepatitis C virus infection in a country with universal access to direct-acting antiviral agents: Data for designing a cost-effective elimination policy in Spain. J Viral Hepat 2020; 27:360-370. [PMID: 31755634 DOI: 10.1111/jvh.13238] [Citation(s) in RCA: 34] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2019] [Revised: 10/30/2019] [Accepted: 11/05/2019] [Indexed: 12/29/2022]
Abstract
Accurate HCV prevalence estimates are necessary for guiding elimination policies. Our aim was to determine the HCV prevalence and assess the cost-effectiveness of a screen-and-treat strategy in the Spanish population. A population-based, cross-sectional study (PREVHEP-ETHON Cohort, Epidemiological sTudy of Hepatic infectiONs; NCT02749864) was performed from July 2015-April 2017. Participants from three Spanish regions were selected using two-stage conglomerate sampling, and stratified by age, with randomized subject selection. Anthropometric and demographic data were collected, and blood samples were taken to detect anti-HCV antibodies/quantify HCV RNA. The cost-effectiveness of the screening strategies and treatment were analysed using a Markov model. Among 12 246 participants aged 20-74 (58.4% females), the overall anti-HCV prevalence was 1.2% (95% CI 1.0-1.4), whereas the detectable HCV-RNA prevalence was 0.3% (0.2-0.4). Infection rates were highest in subjects aged 50-74 years [anti-HCV 1.6% (1.3-1.9), HCV RNA 0.4% (0.3-0.6]. Among the 147 anti-HCV + subjects, 38 (25.9%) had active infections while 109 (74.1%) had been cleared of infection; 44 (40.4%) had cleared after antiviral treatment, whereas 65 (59.6%) had cleared spontaneously. Overall, 59.8% of the anti-HCV + participants were aware of their serological status. Considering a cost of treatment of €7000/patient, implementing screening programmes is cost-effective across all age cohorts, particularly in patients aged 50-54 (negative incremental cost-effectiveness ratio which indicates a cost-saving strategy). The current HCV burden is lower than previously estimated, with approximately 25% of anti-HCV + individuals having an active infection. A strategy of screening and treatment at current treatment prices in Spain is cost-effective across all age cohorts.
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Affiliation(s)
- Javier Crespo
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Santander, Spain.,Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | - Antonio Cuadrado
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Santander, Spain.,Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | - Christie Perelló
- Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, School of Medicine, Universidad Autónoma Madrid, Majadahonda, Spain
| | - Joaquin Cabezas
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Santander, Spain.,Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | - Susana Llerena
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Santander, Spain.,Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | - Javier Llorca
- Department of Epidemiology and Computational Biology, School of Medicine, University of Cantabria, Santander, Spain.,CIBER Epidemiología y Salud Pública (CIBERESP), IDIVAL, s/n, Santander, Spain
| | - Sergio Cedillo
- Outcomes Research Department, Chiltern International/MSD, Tres Cantos, Spain
| | - Elba Llop
- Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, School of Medicine, Universidad Autónoma Madrid, Majadahonda, Spain
| | - María Desamparados Escudero
- Gastroenterology and Hepatology, Servicio Medicina Digestiva del Hospital Clinico Universitario de Valencia (HUCV) Av. de Blasco Ibáñez, Valencia, Spain
| | - Marta Hernández Conde
- Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, School of Medicine, Universidad Autónoma Madrid, Majadahonda, Spain
| | - Laura Puchades
- Gastroenterology and Hepatology, Servicio Medicina Digestiva del Hospital Clinico Universitario de Valencia (HUCV) Av. de Blasco Ibáñez, Valencia, Spain
| | - Carlos Redondo
- Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | - José I Fortea
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Santander, Spain.,Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, Santander, Spain
| | | | - Miguel A Serra
- Gastroenterology and Hepatology, Servicio Medicina Digestiva del Hospital Clinico Universitario de Valencia (HUCV) Av. de Blasco Ibáñez, Valencia, Spain
| | - Jeffrey V Lazarus
- Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain
| | - José Luis Calleja
- Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, School of Medicine, Universidad Autónoma Madrid, Majadahonda, Spain
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19
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Rossotti R, Puoti M. Sexually Transmitted Hepatitis. Sex Transm Infect 2020. [DOI: 10.1007/978-3-030-02200-6_13] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
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20
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Soares J, Ferreira A, Silva-Pinto A, Almeida F, Piñeiro C, Serrão R, Sarmento A. The Influence of Antiretroviral Therapy on Hepatitis C Virus Viral Load and Liver Fibrosis in Human Immunodeficiency Virus-Coinfected Patients: An Observational Study. Intervirology 2019; 62:182-190. [PMID: 31775148 DOI: 10.1159/000503631] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2019] [Accepted: 09/21/2019] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND The role of antiretroviral therapy (ART) for Hepatitis C viral load (HCV-VL) and liver fibrosis is poorly understood. This study aimed at evaluating the influence of ART on HCV-VL and liver fibrosis in human immunodeficiency virus (HIV)/HCV-coinfected patients. METHODS We conducted a retrospective cohort study of HIV/HCV-coinfected patients followed at a tertiary university hospital. RESULTS In total, 143 patients were included. In 61 patients, ART initiation was accompanied by an increase in HCV-VL and a decrease in HIV viral load (HIV-VL), whereas ART suspension led to a decrease in HCV-VL and an increase in HIV-VL. Among the 55 HIV-suppressed patients who switched to a raltegravir (RAL)-containing regimen, median HCV-VL levels decreased significantly, while switching to a rilpivirine-containing regimen did not yield a significant reduction. DISCUSSION If the -treatment of chronic hepatitis starts before ART, ART initiation should be delayed as much as possible. If ART has been started, it is advisable to wait 1 year before initiating chronic hepatitis treatment. RAL as the third agent in an ART regimen could be beneficial in HIV/HCV-coinfected patients, in comparison to other antiretroviral drugs. CONCLUSION The start and the suspension of ART significantly interferes with HCV-VL in HIV/HCV-coinfected patients.
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Affiliation(s)
- Jorge Soares
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal
| | - António Ferreira
- Medicine Department, Hospital de Viana do Castelo, Viana do Castelo, Portugal
| | - André Silva-Pinto
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal,
| | - Francisco Almeida
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal
| | - Carmela Piñeiro
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal
| | - Rosário Serrão
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal
| | - António Sarmento
- Infectious Diseases Department, Centro Hospitalar São João, Porto, Portugal
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21
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Fraňková S, Urbánek P, Husa P, Němeček V, Razavi H, Razavi-Shearer D, Chlíbek R, Šperl J. Chronic hepatitis C in the Czech Republic: Forecasting the disease burden. Cent Eur J Public Health 2019; 27:93-98. [PMID: 31241282 DOI: 10.21101/cejph.a5350] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2018] [Accepted: 04/25/2019] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Chronic HCV infection is associated with cirrhosis of the liver, hepatocellular carcinoma (HCC), and liver transplantation. HCV disease burden and the impact of new potent direct acting antivirals (DAAs) in the Czech Republic are unknown. METHODS Using a modelling framework, HCV disease progression in the Czech Republic was predicted to 2030 under the current standard of care treatment structure. In addition, two strategies to reduce the future burden of HCV infection were modelled: an incremental increase in treatment annually and WHO targets. RESULTS The number of viremic infected individuals in the Czech Republic is estimated to peak in 2026 (n = 55,130) and to decline by 0.5% by 2030 (n = 54,840). The number of individuals with compensated cirrhosis (n = 1,400), decompensated cirrhosis (n = 80), HCC (n = 70), and liver-related deaths (n = 60) is estimated to more than double by 2030. Through aggressive increases in diagnosis and treatment, HCV related mortality may decrease by 70% by 2030. CONCLUSIONS Disease burden associated with chronic HCV infection is projected to peak in the Czech Republic in 30-40 years. Assuming that the current portion of DAAs used remains constant, a significant reduction in HCV disease burden is possible through increased diagnosis and treatment through 2030. This analysis provides evidence in order to facilitate the development of national strategies for HCV care and management in the Czech Republic.
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Affiliation(s)
- Soňa Fraňková
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Petr Urbánek
- Department of Internal Medicine, First Faculty of Medicine, Charles University and Central Military Hospital, Prague, Czech Republic
| | - Petr Husa
- Clinic of Infectious Diseases, University Hospital Brno, Masaryk University, Brno, Czech Republic
| | - Vratislav Němeček
- National Reference Laboratory for Hepatitis, National Institute of Public Health, Prague, Czech Republic
| | - Homie Razavi
- Center for Disease Analysis, Lafayette, Colorado, USA
| | | | - Roman Chlíbek
- Department of Epidemiology, Vaccination Centre, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic
| | - Jan Šperl
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
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22
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Youngberg S, Brandt E, Barve A, Machineni S, Jones CT, Dabovic K, Jones CL, Colvin RA. A first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study to assess the safety, tolerability, and pharmacokinetics of BZF961 with and without ritonavir in healthy adult volunteers. J Drug Assess 2018; 7:66-74. [PMID: 30370176 PMCID: PMC6201795 DOI: 10.1080/21556660.2018.1535438] [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: 06/15/2018] [Accepted: 10/09/2018] [Indexed: 11/01/2022] Open
Abstract
Objective: Infection with hepatitis C virus is the leading indication for liver transplantation and most common cause of infectious disease-related mortality in the United States. BZF961 is a novel inhibitor of the hepatitis C virus NS3-4A protease. Methods: This sequential, three part exploratory first-in-human study investigated the safety and pharmacokinetics of single and multiple ascending oral doses of BZF961 in healthy subjects. The first two parts were randomized, double-blind, placebo-controlled, time-lagged, single and multiple ascending oral dose segments. The third part analyzed the effect of ritonavir on BZF961 pharmacokinetics. Results: BZF961 was generally safe and well-tolerated in single and multiple oral doses in healthy subjects. There were no deaths and no serious adverse events. The most common adverse events were nausea and other gastrointestinal symptoms. Co-administration of ritonavir with BZF961 was well tolerated and increased BZF961 exposure by up to 60-fold, as well as reduced the overall exposure variability. Conclusions: BZF961 was generally safe and well-tolerated and its exposure was boosted by the co-administration of ritonavir.
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Affiliation(s)
| | | | - Avantika Barve
- Novartis Institutes for BioMedical Research, East Hanover, NJ, USA
| | | | | | - Kristina Dabovic
- Novartis Institutes for BioMedical Research, East Hanover, NJ, USA
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23
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Traebert J, Fratoni KRDBP, Rosa LCDD, Traebert E, Schneinder IJC. The burden of hepatitis C infection in a Southern Brazilian State. Rev Soc Bras Med Trop 2018; 51:670-673. [PMID: 30304275 DOI: 10.1590/0037-8682-0098-2017] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2017] [Accepted: 04/20/2018] [Indexed: 11/22/2022] Open
Abstract
INTRODUCTION The study aimed to estimate the burden of hepatitis C in Santa Catarina, Brazil. METHODS An ecologic study was carried out to estimate the disability-adjusted life years (DALY) by summing the number of years of life lost and the number of years lived with disability. RESULTS A rate of 1,075.9 DALY/100,000 population was estimated, and was similar by sex. The highest burden was between the ages of 45 to 59 years and in the Grande Oeste region. CONCLUSIONS The burden of hepatitis C was high and concentrated in adult age groups with variations among regions.
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Affiliation(s)
- Jefferson Traebert
- Programa de Pós-Graduação Stricto Sensu em Ciências da Saúde, Universidade do Sul de Santa Catarina, Palhoça, SC, Brasil
| | | | | | - Eliane Traebert
- Programa de Pós-Graduação Stricto Sensu em Ciências da Saúde, Universidade do Sul de Santa Catarina, Palhoça, SC, Brasil
| | - Ione Jayce Ceola Schneinder
- Programa de Pós-Graduação Stricto Sensu em Ciências da Reabilitação, Universidade Federal de Santa Catarina, Araranguá, SC, Brasil
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Schuch-Goi SB, Scherer JN, Kessler FHP, Sordi AO, Pechansky F, von Diemen L. Hepatitis C: clinical and biological features related to different forms of cocaine use. TRENDS IN PSYCHIATRY AND PSYCHOTHERAPY 2018; 39:285-292. [PMID: 29267513 DOI: 10.1590/2237-6089-2016-0076] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/24/2016] [Accepted: 07/03/2017] [Indexed: 02/07/2023]
Abstract
INTRODUCTION Hepatitis C virus (HCV) infection is related with several liver diseases such as cirrhosis and hepatocellular carcinomas, leading to more than 0.5 million deaths every year and to a great global burden. It is known that injection drug users show a high prevalence of HCV infection, being considered a risk group for this disease. Cocaine users seem to be in greater risk than other drug users, and several hypotheses for this association are being studied. AIM To review data on HCV infection in cocaine users, taking into consideration the relevance of the different routes of drug administration and other risk behaviors. METHODS This was a narrative review performed in the main scientific databases. RESULTS AND CONCLUSION Data suggest that cocaine use could be associated with HCV infection due to the specificities of cocaine consumption pattern, even in those subjects who do not inject drugs, in addition to other risky behaviors, such as tattooing and unprotected sex. Injectable cocaine users seem to be more susceptible to contamination than users who do not inject drugs. However, evidence is pointing to the possibility of infection by sharing drug paraphernalia other than syringes. Moreover, specific immune system impairments caused by cocaine use are also being linked with HCV infection susceptibility, persistence and increased pathological effects.
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Affiliation(s)
- Silvia Bassani Schuch-Goi
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
| | - Juliana Nichterwitz Scherer
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
| | - Felix Henrique Paim Kessler
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
| | - Anne Orgler Sordi
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
| | - Flavio Pechansky
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
| | - Lisia von Diemen
- Centro de Pesquisas em Álcool e Drogas, Centro Colaborador em Álcool e Drogas HCPA/SENAD, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil
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25
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Greenaway C, Makarenko I, Chakra CNA, Alabdulkarim B, Christensen R, Palayew A, Tran A, Staub L, Pareek M, Meerpohl JJ, Noori T, Veldhuijzen I, Pottie K, Castelli F, Morton RL. The Effectiveness and Cost-Effectiveness of Hepatitis C Screening for Migrants in the EU/EEA: A Systematic Review. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2018; 15:E2013. [PMID: 30223539 PMCID: PMC6164358 DOI: 10.3390/ijerph15092013] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/17/2018] [Revised: 08/24/2018] [Accepted: 09/10/2018] [Indexed: 12/16/2022]
Abstract
Chronic hepatitis C (HCV) is a public health priority in the European Union/European Economic Area (EU/EEA) and is a leading cause of chronic liver disease and liver cancer. Migrants account for a disproportionate number of HCV cases in the EU/EEA (mean 14% of cases and >50% of cases in some countries). We conducted two systematic reviews (SR) to estimate the effectiveness and cost-effectiveness of HCV screening for migrants living in the EU/EEA. We found that screening tests for HCV are highly sensitive and specific. Clinical trials report direct acting antiviral (DAA) therapies are well-tolerated in a wide range of populations and cure almost all cases (>95%) and lead to an 85% lower risk of developing hepatocellular carcinoma and an 80% lower risk of all-cause mortality. At 2015 costs, DAA based regimens were only moderately cost-effective and as a result less than 30% of people with HCV had been screened and less 5% of all HCV cases had been treated in the EU/EEA in 2015. Migrants face additional barriers in linkage to care and treatment due to several patient, practitioner, and health system barriers. Although decreasing HCV costs have made treatment more accessible in the EU/EEA, HCV elimination will only be possible in the region if health systems include and treat migrants for HCV.
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Affiliation(s)
- Christina Greenaway
- Division of Infectious Diseases, Jewish General Hospital, McGill University, Montreal, QC H3T 1E2 Canada.
- Centre for Clinical Epidemiology of the Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC H3T 1E2.
- Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC H3A 1A2, Canada.
| | - Iuliia Makarenko
- Centre for Clinical Epidemiology of the Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC H3T 1E2.
| | - Claire Nour Abou Chakra
- Department of Microbiology and Infectious Diseases, Université de Sherbrooke, Sherbrooke, QC J1H 5NG, Canada.
| | - Balqis Alabdulkarim
- Centre for Clinical Epidemiology of the Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC H3T 1E2.
| | - Robin Christensen
- Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital & Department of Rheumatology, Odense University Hospital, DK2000 Odense, Denmark.
| | - Adam Palayew
- Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC H3A 1A2, Canada.
| | - Anh Tran
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney 1450, Australia.
| | - Lukas Staub
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney 1450, Australia.
| | - Manish Pareek
- Department of Infection, Immunity and Inflammation, University of Leicester, Leicester LE1 7RH, UK.
| | - Joerg J Meerpohl
- Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, University of Freiburg, 79110 Freiburg, Germany.
| | - Teymur Noori
- European Centre for Disease Prevention and Control, 169 73 Solna, Sweden.
| | - Irene Veldhuijzen
- Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), 3720 BA Bilthoven, The Netherlands.
| | - Kevin Pottie
- C.T. Lamont Primary Health Care Research Centre, Bruyère Research Institute, Ottawa, ON K1N 5C8, Canada.
- Centre for Global Health, University of Ottawa, Ottawa, ON K1N 5C8, Canada.
| | - Francesco Castelli
- Division of Infectious Diseases, University of Brescia, 255123 Brescia, Italy.
| | - Rachael L Morton
- NHMRC Clinical Trials Centre, The University of Sydney, Sydney 1450, Australia.
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26
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Lawitz E, Bidair M, Marbury T, Jones CT, Barve A, Magnusson B, Barkan DT, Bodendorf U, Bracken K, Canino E, Chen D, Dabovic K, Heimbach T, Ison M, Jones CL, Kovacs SJ, Lakshman JP, Li B, Raman P, Steiner-Swiat R, Thohan S, Wong KA, Zhong W, Colvin RA. The Safety and Antiviral Activity of BZF961 with or without Ritonavir in Patients Infected with Hepatitis C Virus: A Randomized, Multicenter Trial. Clin Ther 2018; 40:1567-1581.e4. [PMID: 30185394 DOI: 10.1016/j.clinthera.2018.07.019] [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: 05/24/2018] [Revised: 07/24/2018] [Accepted: 07/26/2018] [Indexed: 10/28/2022]
Abstract
PURPOSE Infection with hepatitis C virus is the leading cause of infectious disease mortality in the United States. BZF961 is a novel small molecule inhibitor of the hepatitis C virus NS3-4A protease. Here we present the results of a randomized, double-blinded, placebo-controlled, multicentered study in treatment-naïve patients with chronic hepatitis C virus genotype-1 infection. METHODS Patients were enrolled sequentially in 2 parts and treated for 3days. BZF961 was administered as monotherapy (500mg BID for 3 days) or in combination with the cytochrome P450 3A4 inhibitor ritonavir to boost its exposure (BZF961 10, 20, or 50mg QD or BID). FINDINGS BZF961 was safe and well tolerated in the patients studied with no serious adverse events. There were no appreciable differences in adverse events among patients who received BZF961, BZF961 with ritonavir, or placebo. There was a significant, clinically meaningful reduction in viral load from baseline in patients treated either with BZF961 500mg every 12hours alone or BZF961 50mg every 12hours in combination with ritonavir. Activity against the hepatitis C virus of the lower-dose regimens was apparent but more modest. There were no relevant changes from baseline viral loads in placebo-treated patients. IMPLICATIONS Coadministration of ritonavir with BZF961 boosted BZF961 exposure (including Cmin, which is the clinically relevant parameter associated with antiviral activity) in a therapeutic range with less variability compared with BZF961 alone. For strategic reasons, BZF961 is no longer under development.
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Affiliation(s)
- Eric Lawitz
- Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas
| | | | | | | | | | | | - David T Barkan
- Novartis Institutes for BioMedical Research, Emeryville, California
| | | | - Kathryn Bracken
- Novartis Institute for BioMedical Research, Cambridge, Massachusetts
| | - Erica Canino
- Novartis Institutes for BioMedical Research, Emeryville, California
| | - Darlene Chen
- Novartis Institutes for BioMedical Research, Emeryville, California
| | | | | | - Marjorie Ison
- Novartis Institutes for BioMedical Research, Emeryville, California
| | | | - Steven J Kovacs
- Novartis Institute for BioMedical Research, Cambridge, Massachusetts
| | | | - Bin Li
- Novartis Institute for BioMedical Research, Cambridge, Massachusetts
| | | | | | - Sanjeev Thohan
- Novartis Institute for BioMedical Research, Cambridge, Massachusetts
| | - Kelly A Wong
- Novartis Institutes for BioMedical Research, Emeryville, California
| | - Weidong Zhong
- Novartis Institutes for BioMedical Research, Emeryville, California
| | - Richard A Colvin
- Novartis Institute for BioMedical Research, Cambridge, Massachusetts.
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27
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Åberg F, Helenius-Hietala J, Puukka P, Färkkilä M, Jula A. Interaction between alcohol consumption and metabolic syndrome in predicting severe liver disease in the general population. Hepatology 2018; 67:2141-2149. [PMID: 29164643 DOI: 10.1002/hep.29631] [Citation(s) in RCA: 167] [Impact Index Per Article: 23.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2017] [Revised: 10/24/2017] [Accepted: 10/30/2017] [Indexed: 12/21/2022]
Abstract
UNLABELLED The metabolic syndrome and alcohol risk use are both associated with a high prevalence of hepatic steatosis, but only a minority develop liver failure or liver cancer. Few general population studies have analyzed metabolic predictors of such severe liver complications. We studied which metabolic factors best predict severe liver complications, stratified by alcohol consumption, in 6732 individuals without baseline liver disease who participated in the Finnish population-based Health 2000 Study (2000-2001), a nationally representative cohort. Follow-up data from national registers until 2013 were analyzed for liver-related admissions, mortality, and liver cancer. Baseline alcohol use and metabolic factors were analyzed by backward stepwise Cox regression analysis. Eighty-four subjects experienced a severe liver event during follow-up. In the final multivariate model, factors predictive of liver events were age (hazard ratio [HR], 1.02; 95% confidence interval [CI], 1.004-1.04), sex (women: HR, 0.55; 95% CI, 0.34-0.91), alcohol use (HR, 1.002; 95% CI, 1.001-1.002), diabetes (HR, 2.73; 95% CI, 1.55-4.81), low-density lipoprotein (LDL) cholesterol (HR, 0.74; 95% CI, 0.58-0.93), and homeostasis model assessment of insulin resistance (HOMA-IR) (HR, 1.01; 95% CI, 1.004-1.02). Among alcohol risk users (≥210 g/week for men, ≥ 140 g/week for women), diabetes (HR, 6.79; 95% CI, 3.18-14.5) was the only significant predictor. Among nonrisk drinkers, age, alcohol use, smoking, waist circumference, low LDL cholesterol and HOMA-IR were significant independent predictors. The total-to-LDL cholesterol ratio and waist circumference-to-body mass index ratio emerged as additional independent predictors. CONCLUSION Multiple components of the metabolic syndrome independently affected the risk for severe liver disease. Alcohol was significant even when average alcohol consumption was within the limits currently defining nonalcoholic fatty liver disease. (Hepatology 2018;67:2141-2149).
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Affiliation(s)
- Fredrik Åberg
- Transplantation and Liver Surgery Clinic, Helsinki University Hospital, Helsinki University, Helsinki, Finland
| | - Jaana Helenius-Hietala
- Department of Oral and Maxillofacial Diseases, Helsinki University Hospital, Helsinki University, Helsinki, Finland
| | - Pauli Puukka
- Department of Health, National Institute for Health and Welfare, Turku, Finland
| | - Martti Färkkilä
- Department of Gastroenterology, Helsinki University Hospital, Helsinki University, Helsinki, Finland
| | - Antti Jula
- Department of Health, National Institute for Health and Welfare, Turku, Finland
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28
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Mansberg K, Kull K, Salupere R, Prükk T, Margus B, Kariis T, Remmel T, Suurmaa K, Ott K, Jaago K, Šmidt J. A Population-Based Surveillance Study on the Epidemiology of Hepatitis C in Estonia. ACTA ACUST UNITED AC 2018; 54:medicina54010009. [PMID: 30344240 PMCID: PMC6037246 DOI: 10.3390/medicina54010009] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2018] [Revised: 03/20/2018] [Accepted: 03/21/2018] [Indexed: 02/07/2023]
Abstract
Background and objective: The hepatitis C virus (HCV)-infected patients serve as a reservoir for transmission of the disease to others and are at risk of developing chronic hepatitis C, cirrhosis, and hepatocellular carcinoma. Although the epidemiological data of high rate HCV infection have been obtained in many countries, such data are insufficient in Estonia. Therefore, the aim of the study was to analyze country-specific data on HCV patients. Materials and methods: Data about age, gender, diagnosis, possible risk factors, coinfections, HCV genotypes, liver fibrosis stages and extrahepatic manifestations were collected from 518 patients. Results: The most common risk factors for hepatitis C were injection drug use and tattooing in the 30–39 and 40–49 year age groups, and blood transfusion in the 50–59 and 60–69 year age groups. The other risk factors established were profession-related factors and sexual contact. The prevailing viral genotype among the HCV infected patients was genotype 1 (69% of the patients) followed by genotype 3 (25%). Genotypes 1 and 3 correlated with blood transfusions before 1994, drug injections and tattooing. Conclusions: Our study provides the best representation of genotype distribution across Estonia. As a result of the study, valuable data has been collected on hepatitis C patients in Estonia.
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Affiliation(s)
- Kairi Mansberg
- Department of Gastroenterology, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
- Internal Disease Clinic, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
| | - Karin Kull
- Department of Gastroenterology, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
- Internal Disease Clinic, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
| | - Riina Salupere
- Department of Gastroenterology, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
- Internal Disease Clinic, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
| | - Tiina Prükk
- Department of Gastroenterology, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
- Internal Disease Clinic, Tartu University Hospital, University of Tartu, 51014 Tartu, Estonia.
| | - Benno Margus
- Department of Gastroenterology, East Tallinn Central Hospital, 10138 Tallinn, Estonia.
| | - Toomas Kariis
- Department of Gastroenterology, East Tallinn Central Hospital, 10138 Tallinn, Estonia.
| | - Triin Remmel
- Department of Gastroenterology, East Tallinn Central Hospital, 10138 Tallinn, Estonia.
| | - Külliki Suurmaa
- Department of Gastroenterology and Infectios Diseases Clinic, West Tallinn Central Hospital, 10138 Tallinn, Estonia.
| | - Kristi Ott
- Department of Gastroenterology and Infectios Diseases Clinic, West Tallinn Central Hospital, 10138 Tallinn, Estonia.
| | - Krista Jaago
- Internal Disease Clinic, Pärnu Hospital, 80010 Pärnu, Estonia.
| | - Jelena Šmidt
- Internal Disease Clinic, East Viru Central Hospital, 31024 Kohtla-Järve, Estonia.
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29
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Marshall AD, Cunningham EB, Nielsen S, Aghemo A, Alho H, Backmund M, Bruggmann P, Dalgard O, Seguin-Devaux C, Flisiak R, Foster GR, Gheorghe L, Goldberg D, Goulis I, Hickman M, Hoffmann P, Jancorienė L, Jarcuska P, Kåberg M, Kostrikis LG, Makara M, Maimets M, Marinho RT, Matičič M, Norris S, Ólafsson S, Øvrehus A, Pawlotsky JM, Pocock J, Robaeys G, Roncero C, Simonova M, Sperl J, Tait M, Tolmane I, Tomaselli S, van der Valk M, Vince A, Dore GJ, Lazarus JV, Grebely J. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. Lancet Gastroenterol Hepatol 2018; 3:125-133. [DOI: 10.1016/s2468-1253(17)30284-4] [Citation(s) in RCA: 109] [Impact Index Per Article: 15.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2017] [Revised: 08/18/2017] [Accepted: 08/18/2017] [Indexed: 01/15/2023]
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30
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Hansen JF, Juul Nielsen M, Nyström K, Leeming DJ, Lagging M, Norkrans G, Brehm Christensen P, Karsdal M. PRO-C3: a new and more precise collagen marker for liver fibrosis in patients with chronic hepatitis C. Scand J Gastroenterol 2018; 53:83-87. [PMID: 29069995 DOI: 10.1080/00365521.2017.1392596] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVE Detecting significant fibrosis and cirrhosis remains important in treatment and follow-up of patients with chronic hepatitis C Infection (CHC). The aim of this study was to assess the ability of PRO-C3 to identify significant fibrosis (Ishak score ≥3) and cirrhosis (Ishak score ≥5) both as a single test and as a part of algorithms. MATERIALS AND METHODS PRO-C3 was assessed in baseline samples from the NORDynamIC trial. 270 patients were stratified into groups according to baseline biopsy. Baseline APRI, FIB-4 and GUCI scores were available for comparison in 232 patients. RESULTS PRO-C3 increased with Ishak scores (p = .001). Area under the curve (AUC) for significant fibrosis was 0.75 (95% CI 0.68-0.81) and 0.76 (95% CI 0.68-0.84) for cirrhosis. FIB-4, APRI and GUCI had similar AUCs. In a PRO-C3 algorithm including age, platelet count, body mass index (BMI) and international normalised ratio (INR), the diagnostic efficacy improved to 0.85 (CI 0.80-0.89) and 0.90 (IQR 0.84-0.96) for significant fibrosis and cirrhosis, respectively. CONCLUSIONS In our study, PRO-C3 was an independent predictor of fibrosis stage, and may play an important role in managing CHC patients.
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Affiliation(s)
| | | | - Kristina Nyström
- c Department of Infectious Diseases/Virology , Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
| | | | - Martin Lagging
- c Department of Infectious Diseases/Virology , Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
| | - Gunnar Norkrans
- c Department of Infectious Diseases/Virology , Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
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31
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Janiak M, Caraballo Cortés K, Perlejewski K, Kubicka-Russel D, Grabarczyk P, Demkow U, Radkowski M. Next-Generation Sequencing of Hepatitis C Virus (HCV) Mixed-Genotype Infections in Anti-HCV-Negative Blood Donors. ADVANCES IN EXPERIMENTAL MEDICINE AND BIOLOGY 2018; 1096:65-71. [PMID: 29594753 DOI: 10.1007/5584_2018_190] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
The infection with more than one hepatitis C virus (HCV) genotype especially in subjects with a high risk of multiple HCV exposures has been demonstrated. The role of HCV mixed-genotype infection in viral persistence and treatment effect is not fully understood. The prevalence of such infection varies greatly depending on the technique used for genotype determination and studied population. Next-generation sequencing (NGS) which is suitable for extensive analysis of complex viral populations is a method of choice for studying mixed infections. The aim of the present study was to determine the prevalence of mixed-genotype HCV infections in the Polish seronegative, HCV-RNA-positive blood donors (n = 76). Two-step PCR was used for amplification of 5'-UTR of HCV. Using pyrosequencing altogether, 381,063 reads were obtained. The raw reads were trimmed and subjected to similarity analysis against the entire unfiltered NCBI nt database. Results obtained from NGS were compared with the standard genotyping. One (1.3%) mixed-genotype [3a, 2989 reads (94.8%); 1b, 164 reads (5.2%)] infection was found in a sample diagnosed as genotype 3a only by routine testing. Two samples were identified with different genotypes, compared to routine testing. In conclusion, NGS is a sensitive method for HCV genotyping. The prevalence of mixed-genotype HCV infections in blood donors is low.
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Affiliation(s)
- Maciej Janiak
- Department of Immunopathology of Infectious and Parasitic Diseases, Medical University of Warsaw, Warsaw, Poland
| | - Kamila Caraballo Cortés
- 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
| | - Dorota Kubicka-Russel
- Department of Virology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | - Piotr Grabarczyk
- Department of Virology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | - Urszula Demkow
- Department of Laboratory Medicine and Clinical Immunology of Developmental Age, Medical University of Warsaw, Warsaw, Poland
| | - Marek Radkowski
- Department of Immunopathology of Infectious and Parasitic Diseases, Medical University of Warsaw, Warsaw, Poland
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32
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Sicras-Mainar A, Navarro-Artieda R, Sáez-Zafra M. Comorbidity, concomitant medication, use of resources and healthcare costs associated with chronic hepatitis C virus carriers in Spain. GASTROENTEROLOGIA Y HEPATOLOGIA 2017; 41:234-244. [PMID: 29287992 DOI: 10.1016/j.gastrohep.2017.11.008] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/04/2017] [Revised: 11/04/2017] [Accepted: 11/26/2017] [Indexed: 02/08/2023]
Abstract
OBJECTIVES To assess the comorbidity, concomitant medications, healthcare resource use and healthcare costs of chronic hepatitis C virus patients in the Spanish population. PATIENTS AND METHODS Retrospective, observational, non-interventional study. Patients included were≥18 years of age who accessed medical care between 2010-2013. Patients were divided into 2 groups based on the presence or absence of liver cirrhosis. The follow-up period was 12 months. Main assessment criteria included general comorbidity level (determined by the resource utilisation band score) and prevalence of specific comorbidities, concomitant medications, healthcare resource use and healthcare costs. Statistical analysis was performed using regression models and ANCOVA, P<.05. RESULTS One thousand fifty-five patients were enrolled, the mean age was 57.9 years and 55.5% were male. A percentage of 43.5 of patients had a moderate level of comorbidity according to the resource utilisation band score. The mean time from diagnosis was 18.1 years and 7.5% of the patients died during the follow-up period. The most common comorbidities were dyslipidaemia (40.3%), hypertension (40.1%) and generalised pain (38.1%). Cirrhosis was associated with cardiovascular events (OR 3.8), organ failures (OR 2.2), alcoholism (OR 2.1), diabetes (OR 1.2) and age (OR 1.2); P<.05. The most commonly used medications were anti-infectives (67.8%) and nervous system medications (66.8%). The mean total cost per patient was 3,198€ (71.5% healthcare costs, 28.5% indirect/non-healthcare costs). In the corrected model, the total costs per patient-year were 2,211€ for those without cirrhosis and 7,641€ for patients with cirrhosis; P<.001. CONCLUSIONS Chronic hepatitis C virus patients are associated with a high level of comorbidity and the use of concomitant medications, especially in patients with liver cirrhosis. Chronic hepatitis C virus infection represents a substantial economic burden on the Spanish National Health System.
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Affiliation(s)
| | - Ruth Navarro-Artieda
- Documentación Médica, Hospital Germans Trias i Pujol, Badalona, Barcelona, España
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33
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Hansen JF, Hallager S, Øvrehus A, Weis N, Brehm Christensen P, Pedersen C. Late Presentation for Care Among Patients With Chronic Hepatitis C: Prevalence and Risk Factors. Open Forum Infect Dis 2017; 5:ofx257. [PMID: 29367939 PMCID: PMC5774505 DOI: 10.1093/ofid/ofx257] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2017] [Accepted: 11/21/2017] [Indexed: 01/22/2023] Open
Abstract
Patients with chronic hepatitis C may have advanced fibrosis at first evaluation. Using the European Association for the Study of the Liver (EASL) definition (FibroScan® >9.5 kPa) for “late presenter for care” (LP), we found that 32% (169 of 527) of patients were LP. Being a LP was associated with increasing age and a history of alcohol overuse.
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Affiliation(s)
- Janne Fuglsang Hansen
- Department of Infectious Diseases, Odense University Hospital, Denmark.,Clinical Institute, University of Southern Denmark, Odense
| | - Sofie Hallager
- Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark
| | - Anne Øvrehus
- Department of Infectious Diseases, Odense University Hospital, Denmark.,Clinical Institute, University of Southern Denmark, Odense
| | - Nina Weis
- Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark.,Faculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Denmark
| | - Peer Brehm Christensen
- Department of Infectious Diseases, Odense University Hospital, Denmark.,Clinical Institute, University of Southern Denmark, Odense
| | - Court Pedersen
- Department of Infectious Diseases, Odense University Hospital, Denmark.,Clinical Institute, University of Southern Denmark, Odense
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Meijerink H, White RA, Løvlie A, de Blasio BF, Dalgard O, Amundsen EJ, Melum E, Kløvstad H. Modelling the burden of hepatitis C infection among people who inject drugs in Norway, 1973-2030. BMC Infect Dis 2017; 17:541. [PMID: 28774261 PMCID: PMC5543437 DOI: 10.1186/s12879-017-2631-2] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2017] [Accepted: 07/25/2017] [Indexed: 02/08/2023] Open
Abstract
Background Lack of Hepatitis C virus (HCV) incidence data in (Norwegian) high-risk groups impedes the ability to make informed decisions on prevention measures. Thus we rely on modelling to estimate the incidence and burden of HCV infections. Methods We constructed a compartmental model for HCV infections in Norway among active and former people who inject drugs (PWIDs). We based yearly transition rates on literature. The model was fitted to absolute numbers of hepatitis C associated cirrhosis, hepatocellular carcinoma (HCC) and death from national data sources (2000–2013). We estimated the number (95%CI) of HCV infections, cirrhosis, HCC and death and disability adjusted life years (DALYs) due to HCV infections in Norway, 1973–2030. We assumed treatment rates in the projected period were similar to those in 2013. Results The estimated proportion of chronic HCV (including those with cirrhosis and HCC) among PWIDs was stable from 2000 (49%; 4441/9108) to 2013 (43%; 3667/8587). We estimated that the incidence of HCV among PWIDs was 381 new infections in 2015. The estimated number of people with cirrhosis, HCC, and liver transplant was predicted to increase until 2022 (1537 people). DALYs among active PWIDs estimated to peak in 2006 (3480 DALYs) and decrease to 1870 DALYs in 2030. Chronic HCV infection contributes most to the total burden of HCV infection, and peaks at 1917 DALYs (52%) in 2007. The burden of HCV related to PWID increased until 2006 with 81/100,000 DALYs inhabitants and decreased to 68/100,000 DALYs in 2015. Conclusion The burden of HCV associated with injecting drug use is considerable, with chronic HCV infection contributing most to the total burden. This model can be used to estimate the impact of different interventions on the HCV burden in Norway and to perform cost-benefit analyses of various public health measures. Electronic supplementary material The online version of this article (doi:10.1186/s12879-017-2631-2) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Hinta Meijerink
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway.,European Programme for Intervention Epidemiology Training (EPIET), European Centre for Disease Prevention and Control, (ECDC), Stockholm, Sweden
| | - Richard A White
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway
| | - Astrid Løvlie
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway
| | - Birgitte Freiesleben de Blasio
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway.,Department of Biostatistics, Oslo Centre for Biostatistics and Epidemiology, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway
| | - Olav Dalgard
- Akershus University Hospital, Lørenskog, Norway.,Medical Faculty, Oslo University, Oslo, Norway
| | - Ellen J Amundsen
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway
| | - Espen Melum
- Norwegian PSC Research Center, Division of Surgery, Inflammatory Medicine and Transplantation, Oslo University Hospital, Rikshospitalet, Oslo, Norway.,Section of Gastroenterology, Division of Surgery, Inflammatory Medicine and Transplantation, Oslo University Hospital, Rikshospitalet, Oslo, Norway.,Research Institute of Internal Medicine, Division of Surgery, Inflammatory Medicine and Transplantation, Oslo University Hospital, Rikshospitalet, Oslo, Norway
| | - Hilde Kløvstad
- Norwegian Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway.
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Ascione A, Fontanella L, Imparato M, Rinaldi L, De Luca M. Mortality from cirrhosis and hepatocellular carcinoma in Western Europe over the last 40 years. Liver Int 2017; 37:1193-1201. [PMID: 28111883 DOI: 10.1111/liv.13371] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2016] [Accepted: 01/17/2017] [Indexed: 12/16/2022]
Abstract
BACKGROUND & AIMS Cirrhosis (LC) and hepatocellular carcinoma (HCC) are highly prevalent in Europe, with accompanying high mortality rates and social costs. As epidemiological data on these diseases are scarce, age-standardized death rate (ASDR) can serve as an indirect assessment of their burden. METHODS We analysed the ASDRs for LC and HCC from data reported in the WHO official death registries from 1970 to 2010, and compared ASDRs over the decades. The European Detailed Mortality Database was also used as source of data. RESULTS In 1970, Portugal had the highest reported mortality for LC, followed by France and Italy. However, in 2010, Finland, Austria and Germany were respectively the three highest, while the UK showed the highest increase over those four decades (+284.8%). The annual ASDRs for LC have dropped in Europe from 20.4/105 inhabitants in 1970 to 9.6 in 2010; a 53% decrease. For HCC, Spain, Italy and Denmark were ranked first through third, while in 2010 Italy, France and Luxembourg replaced them. Portugal had the highest increase (+654.7%). In 1980-2010, the ASDR for HCC in Europe increased from 3.4/105 inhabitants to 6.3, up 85.4%. In the majority of nations-except for the UK, Finland and Ireland-there was a decrease in LC mortality and an increase for HCC mortality. CONCLUSIONS The LC mortality rate is decreasing in Europe, yet there is a significant increase in HCC mortality. This phenomenon requires greater attention so we can understand the risk factors and implement preventive measures.
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Affiliation(s)
- Antonio Ascione
- Department of Medicine, Centre for Liver Disease, Buon Consiglio - Fatebenefratelli Hospital, Naples, Italy
| | - Luca Fontanella
- Department of Medicine, Centre for Liver Disease, Buon Consiglio - Fatebenefratelli Hospital, Naples, Italy
| | - Michele Imparato
- Department of Medicine, Centre for Liver Disease, Buon Consiglio - Fatebenefratelli Hospital, Naples, Italy
| | - Luca Rinaldi
- Department of Scienze Mediche Chirurgiche Neurologiche Metaboliche e dell'Invecchiamento, Second University of Naples, Naples, Italy
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Non-invasive liver fibrosis assessment and HCV treatment initiation within a systematic screening program in HIV/HCV coinfected patients. Wien Klin Wochenschr 2017; 130:105-114. [PMID: 28744597 PMCID: PMC5816107 DOI: 10.1007/s00508-017-1231-x] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2017] [Accepted: 06/26/2017] [Indexed: 12/14/2022]
Abstract
BACKGROUND AND AIM Hepatitis C virus (HCV) therapy should be considered without delay in all patients with significant (SIGFIB) or advanced liver fibrosis (ADVFIB). We aimed to investigate the rates of treatment initiation with interferon-free regimens within a screening program for SIGFIB/ADVFIB in human immunodeficiency virus/HCV coinfected patients (HIV/HCV). METHODS The FIB-4 was calculated in all HIV/HCV from 2014-2016. HIV/HCV were counselled by the HIV clinic and referred to the Division of Gastroenterology and Hepatology for transient elastography (TE) and evaluation for HCV therapy. Patients were stratified by FIB-4 of </≥1.45 (established cut-off for ruling out ADVFIB) and SIGFIB/ADVFIB were defined by liver stiffness >7.1 kPa/>9.5 kPa, respectively. RESULTS Among 1348 HIV+ patients, 16% (210/1348) had detectable HCV-RNA. One hundred HIV/HCV had a FIB-4 ≥1.45. Among these, 57% (57/100) underwent TE. The majority of these patients had SIGFIB (75%; 43/57) or ADVFIB (37%; 21/57), however, interferon-free treatment was initiated in only 56% (24/43). In addition, fifty-two percent (57/110) of HIV/HCV with FIB-4 <1.45 underwent TE. Interestingly, 40% (23/57) and 18% (10/57) of these patients showed SIGFIB or even ADVFIB, respectively, and 78% (18/23) finally received interferon-free treatment. Overall, only 20% (42/210) of HIV/HCV received interferon-free treatment. CONCLUSION FIB-4 was not useful for ruling out SIGFIB/ADVFIB in our cohort of HIV/HCV. Treatment was initiated only in a small proportion (20%) of HIV/HCV during the first 2 years of interferon-free treatment availability, although the observed proportion of patients with SIGFIB (assessed by TE) was considerably higher (58%). Thus, it requires the ongoing combined efforts of both HIV and HCV specialists to increase treatment uptake rates in this special population.
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Zaily DG, Marlen CF, Santiago DC, Gillian MD, Carmen VS, Zurina CE, Enrique R. AS, Liz AL, Lisset GF, Sacha LDV, Elena FB. Clinical Evaluation of Terap C Vaccine in Combined Treatment with Interferon and Ribavirin in Patients with Hepatitis C. CURRENT THERAPEUTIC RESEARCH 2017; 85:20-28. [PMID: 29158855 PMCID: PMC5681293 DOI: 10.1016/j.curtheres.2017.04.006] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Accepted: 04/14/2017] [Indexed: 02/07/2023]
Abstract
BACKGROUND An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects. The development of a new treatment modality is needed. One possible modality could be specific immunotherapy. Terap C is a therapeutic vaccine candidate composed of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120. OBJECTIVE To assess the safety and efficacy of concomitant therapy with the candidate vaccine, Terap C, IFN α-2b and ribavirin in untreated individuals with HCV genotype 1 infection. METHODS This was a Phase II randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of Terap C concomitant with IFN α-2b/RBV in 92 treatment-naïve patients with HCV genotype 1 infection. The study was conducted at the Gastroenterology Institute in Havana, Cuba. Patients were randomly assigned to 1 of 5 groups. The control group (Group 1) received IFN α-2b/RBV and placebo for 48 weeks. Groups 2 and 3 were administered Terap C 6 and 9 times, respectively, in addition to standard IFN α-2b/RBV treatment. In groups 4 and 5, Terap C was introduced 12 weeks after the initiation of IFN α-2b/RBV and administered 6 and 9 times, respectively, concomitant with IFN α-2b/RBV. RESULTS All patients showed some adverse events. Out of 3615 adverse events, only 18.8% were considered to be probably associated with administration of Terap C. Most events (47.4%) were considered to be improbably associated with of administration Terap C. Only 33.8% were considered possibly temporarily associated with Terap C, and can be explained by the use of conventional IFN α-2b + RBV or by HCV itself. The most common adverse events (≥65%) observed were pain at the injection site, headache, asthenia, psychiatric disturbances, fever, and gastrointestinal symptoms. Regarding sustained virological response, a 20% superiority was observed in the patients who received concomitant Terap C treatments from the beginning of the study compared with those who started after Week 12. CONCLUSIONS Vaccination with Terap C in patients with chronic HCV infection was safe and well tolerated. Clinical trial protocol code: IG/VHI/HC/0701; Public Register Code: RPCEC00000074.
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Chlibek R, Smetana J, Sosovickova R, Gal P, Dite P, Stepanova V, Pliskova L, Plisek S. Prevalence of hepatitis C virus in adult population in the Czech Republic - time for birth cohort screening. PLoS One 2017; 12:e0175525. [PMID: 28406947 PMCID: PMC5391198 DOI: 10.1371/journal.pone.0175525] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2017] [Accepted: 03/27/2017] [Indexed: 12/15/2022] Open
Abstract
Chronic hepatitis C is curable disease. Low detection rate could be one of the reasons of poor treatment uptake. It is important to identify HCV prevalence and anti-hepatitis C virus (HCV) positive patients in population by effective screening strategy such as risk-based or birth cohort screening programs. There are no national population-based estimates of the HCV prevalence in the Czech Republic (CZ). The most recent seroprevalence survey determined a prevalence of positive anti-HCV antibodies of 0.2% (in 2001). The aim of the study was to determine the seroprevalence of HCV, HCV viraemia and HCV genotype in the CZ adult population. We also estimated the number of persons living with chronic hepatitis C in CZ. The examined group included 3000 adults, 18-90 years of age enrolled in 2015. All serum samples were examined to determined anti-HCV antibodies positivity, HCV-RNA positivity and genotypes. Of the 3000 samples, 50 were found to be anti-HCV-positive, for a seroprevalence of 1.67% (2.39% in males, 0.98% in females). The overall prevalence of positive HCV RNA was 0.93%: 1.5% in males, 0.39% in females. HCV genotype (GT) 1a was determined in 25%, GT 1b in 25% and GT 3a in 46%. Since 2001, the HCV seroprevalence has increased 8-fold. The highest HCV seroprevalence occurred in males aged 30-44 years. We can estimate that there are more than 140,000 people with HCV antibodies and more than 80,000 people with chronic hepatitis C living in the CZ. The introduction of birth cohort HCV screening could be beneficial for the country.
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Affiliation(s)
- Roman Chlibek
- Department of Epidemiology, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic
| | - Jan Smetana
- Department of Epidemiology, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic
| | - Renata Sosovickova
- Department of Epidemiology, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic
| | - Peter Gal
- Military Health Institute, Prague, Czech Republic
| | - Petr Dite
- Military Health Institute, Prague, Czech Republic
| | - Vlasta Stepanova
- Department of Clinical Microbiology, University Hospital Hradec Kralove, Czech Republic
| | - Lenka Pliskova
- Department of Clinical Chemistry and Diagnostics, University Hospital Hradec Kralove, Czech Republic
| | - Stanislav Plisek
- Department of Infectious Diseases, Charles University Medical Faculty and University Hospital Hradec Kralove, Czech Republic
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Pourmarzi D, Hall L, Rahman T, Lim D, FitzGerald G. Clinical effectiveness, cost-effectiveness and acceptability of community-based management of chronic hepatitis C: a mixed methods systematic review protocol. ACTA ACUST UNITED AC 2017; 15:914-931. [DOI: 10.11124/jbisrir-2016-003103] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/21/2023]
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Mozalevskis A, Eramova I, Safreed-Harmon K, Lazarus JV. Hepatitis B and C surveillance and screening programmes in the non-EU/EEA Member States of the WHO European Region: survey findings from 10 countries, 2012. ACTA ACUST UNITED AC 2017; 21:30245. [PMID: 27277421 DOI: 10.2807/1560-7917.es.2016.21.22.30245] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2015] [Accepted: 06/02/2016] [Indexed: 11/20/2022]
Abstract
The hepatitis B virus (HBV) and hepatitis C virus (HCV) epidemics warrant a comprehensive response based on reliable population-level information about transmission, disease progression and disease burden, with national surveillance systems playing a major role. In order to shed light on the status of surveillance in countries of the World Health Organization (WHO) European Region outside of the European Union and European Economic Area (EU/EEA), we surveyed 18 countries in Central and Eastern Europe. Among the 10 countries that responded, the common features of many surveillance systems included mandatory surveillance, passive case-finding and the reporting of both acute and chronic HBV and HCV. Only some countries had surveillance systems that incorporated the tracking of associated conditions and outcomes such as cirrhosis and liver transplantation. Screening programmes for some key populations appeared to be in place in many countries, but there may be gaps in relation to screening programmes for people who inject drugs, prisoners, sex workers and men who have sex with men. Nonetheless, important components of a surveillance structure are in place in the responding study countries. It is advisable to build on this structure to develop harmonised HBV and HCV surveillance for all 53 Member States of the WHO European Region following the example of the system recently instituted in EU/EEA countries.
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Affiliation(s)
- Antons Mozalevskis
- World Health Organization (WHO) Regional Office for Europe, Copenhagen, Denmark
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Greenaway C, Azoulay L, Allard R, Cox J, Tran VA, Abou Chakra CN, Steele R, Klein M. A population-based study of chronic hepatitis C in immigrants and non-immigrants in Quebec, Canada. BMC Infect Dis 2017; 17:140. [PMID: 28193199 PMCID: PMC5307836 DOI: 10.1186/s12879-017-2242-y] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2016] [Accepted: 02/02/2017] [Indexed: 01/20/2023] Open
Abstract
BACKGROUND Immigrants originating from intermediate and high HCV prevalence countries may be at increased risk of exposure to hepatitis C infection (HCV) in their countries of origin, however they are not routinely screened after arrival in most low HCV prevalence host countries. We aimed to describe the epidemiology of HCV in immigrants compared to the Canadian born population. METHODS Using the reportable infectious disease database linked to the landed immigration database and several provincial administrative databases, we assembled a cohort of all reported cases of HCV in Quebec, Canada (1998-2008). Underlying co-morbidities were identified in the health services databases. Stratum specific rates of reported cases/100,000, rate ratios (RRs) and trends over the study period were estimated. RESULTS A total of 20,862 patients with HCV were identified, among whom 1922 (9.2%) were immigrants. Immigrants were older and diagnosed a mean of 9.8 ± 7 years after arrival. The Canadian born population was more likely to have behavior co-morbidities (problematic alcohol or drug use) and HIV co-infection. Immigrants from Sub-Saharan Africa, Asia and Eastern Europe had the highest HCV reported rates with RRs compared to non-immigrants ranging from 1.5 to 1.7. The age and sex adjusted rates decreased by 4.9% per year in non-immigrants but remained unchanged in immigrants. The proportion of HCV occurring in immigrants doubled over the study period from 5 to 11%. CONCLUSIONS Immigrants from intermediate and high HCV prevalence countries are at increased risk for HCV and had a mean delay in diagnosis of almost 10 years after arrival suggesting that they may benefit from targeted HCV screening and earlier linkage to care.
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Affiliation(s)
- Christina Greenaway
- Division of Infectious Diseases, Jewish General Hospital, McGill University, 3755 Côte St. Catherine Road, Room E-0057, Montreal, PQ H3T 1E2 Canada
- Centre for Clinical Epidemiology, Lady Davis Research Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Canada
| | - Laurent Azoulay
- Centre for Clinical Epidemiology, Lady Davis Research Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Canada
- Department of Oncology, McGill University, Montreal, Canada
| | - Robert Allard
- Department of Oncology, McGill University, Montreal, Canada
- Montreal Public Health Department, Montreal, Canada
| | - Joseph Cox
- Sexually Transmitted Infections Division, Montreal Public Health Department, Montreal, Canada
| | - Viet Anh Tran
- Centre for Clinical Epidemiology, Lady Davis Research Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Canada
| | - Claire Nour Abou Chakra
- Centre for Clinical Epidemiology, Lady Davis Research Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Canada
| | - Russ Steele
- Centre for Clinical Epidemiology, Lady Davis Research Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Canada
- Department of Mathematics and Statistics, McGill University, Montreal, Canada
| | - Marina Klein
- Division of Infectious Diseases, McGill University Health Center, McGill University, Montreal, Canada
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Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis 2017; 3:144-151. [PMID: 27788579 DOI: 10.1021/acsinfecdis.6b00138] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
Hepatitis C virus (HCV) infection is a significant cause of liver disease affecting 80-150 million people globally. Diacylglycerol transferase 1 (DGAT-1), a triglyceride synthesis enzyme, is important for the HCV life cycle in vitro. Pradigastat, a potent DGAT-1 inhibitor found to lower triglycerides and HgbA1c in patients, was investigated for safety and efficacy in patients with HCV. This was a two-part study. In the in vitro study, the effect of pradigastat on virus production was evaluated in infected cells in culture. In the clinical study ( https://clinicaltrials.gov/ct2/show/NCT01387958 ), 32 patients with HCV infection were randomized to receive pradigastat or placebo (26:6) once daily for 14 days. Primary efficacy outcomes were serum viral RNA and alanine aminotransferase levels. In vitro, pradigastat significantly reduced virus production, consistent with inhibition of viral assembly and release. However, the clinical study was prematurely terminated for lack of efficacy. There was no significant change in serum viral RNA levels after dosing with pradigastat or placebo for 14 days. Pradigastat was safe and well-tolerated in this population. Most treatment-emergent adverse events were gastrointestinal; there were no hepatic adverse events. Although pradigastat had a potent antiviral effect in vitro, no significant antiviral effect was observed in patients at predicted efficacious exposures.
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Affiliation(s)
- Edward Gane
- Auckland Clinical Sciences, Grafton, Auckland 1010, New Zealand
| | - Catherine Stedman
- Christchurch Hospital and University of Otago, Christchurch 4710, New Zealand
| | - Kiran Dole
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Jin Chen
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Charles Daniel Meyers
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Brigitte Wiedmann
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Jin Zhang
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Prakash Raman
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
| | - Richard A. Colvin
- Novartis Institutes for BioMedical Research, Cambridge, Massachusetts 02139, United States
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Mühlbacher AC, Sadler A. The Probabilistic Efficiency Frontier: A Framework for Cost-Effectiveness Analysis in Germany Put into Practice for Hepatitis C Treatment Options. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2017; 20:266-272. [PMID: 28237207 DOI: 10.1016/j.jval.2016.12.015] [Citation(s) in RCA: 36] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/11/2016] [Revised: 12/20/2016] [Accepted: 12/20/2016] [Indexed: 05/22/2023]
Abstract
BACKGROUND The German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) adapted the efficiency frontier (EF) approach to conform to statutory provisions on cost-effectiveness analysis of health technologies. EF serves as a framework for evaluating cost-effectiveness and indirectly for pricing and reimbursement decisions. OBJECTIVES To calculate an EF on the basis of single multidimensional benefit by taking patient preferences and uncertainty into account; to evaluate whether EF is useful to inform decision makers about cost-effectiveness of new therapies; and to find whether a treatment is efficient at given prices demonstrated through a case study on chronic hepatitis C. METHODS A single multidimensional benefit was calculated by linear additive aggregation of multiple patient-relevant end points. End points were identified and weighted by patients in a previous discrete-choice experiment (DCE). Aggregation of overall benefit was ascertained using preferences and clinical data. Monte-Carlo simulation was applied. Uncertainty was addressed by price acceptability curve (PAC) and net monetary benefit (NMB). RESULTS The case study illustrates that progress in benefit and efficiency of hepatitis C virus treatments could be depicted very well with the EF. On the basis of cost, effect, and preference data, the latest generations of interferon-free treatments are shown to yield a positive NMB and be efficient at current prices. CONCLUSIONS EF was implemented taking uncertainty into account. For the first time, a DCE was used with the EF. The study shows how DCEs in combination with EF, PAC, and NMB can contribute important information in the course of reimbursement and pricing decisions.
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Affiliation(s)
- Axel C Mühlbacher
- Gesundheitsökonomie und Medizinmanagement, Hochschule Neubrandenburg, Neubrandenburg, Germany.
| | - Andrew Sadler
- Gesundheitsökonomie und Medizinmanagement, Hochschule Neubrandenburg, Neubrandenburg, Germany
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Ethgen O, Sanchez Gonzalez Y, Jeanblanc G, Duguet A, Misurski D, Juday T. Public health impact of comprehensive hepatitis C screening and treatment in the French baby-boomer population. J Med Econ 2017; 20:162-170. [PMID: 27590836 DOI: 10.1080/13696998.2016.1232725] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
Abstract
OBJECTIVE To estimate the public health impact of comprehensive hepatitis C virus (HCV) screening and access to all-oral, interferon (IFN)-free direct-acting antivirals (DAAs) in the French baby-boomer population (1945-1965 birth cohorts). METHODS A sequential, multi-cohort, health-state transition model was developed to assess the impact of different hepatitis C screening and treatment strategies on clinical and economic outcomes in the 1945-1965 birth cohorts. Patients newly-diagnosed with chronic HCV were projected each year from 2016 to 2036 under three screening scenarios (70% [low], 75% [intermediate], and 80% [high] HCV awareness in 2036). Healthcare costs and clinical outcomes (number of liver-related deaths, quality-adjusted life-years [QALYs], life-years [LYs] spent in sustained virologic response [SVR] or with decompensated cirrhosis, hepatocellular carcinoma, or liver transplant) were compared among five treatment strategies (no antiviral therapy; IFN + ribavirin + protease inhibitor for fibrosis stages F2-F4, IFN-based DAAs for stages F2-F4, IFN-free DAAs for stages F2-F4, and IFN-free DAAs for stages F0-F4). RESULTS Diagnosis of HCV genotype 1 was projected for 4,953, 6,600, and 8,368 individuals in the low, intermediate, and high screening scenarios, respectively. In the intermediate scenario, IFN-free DAAs for stages F0-F4 had a favorable cost-effectiveness profile vs IFN-based or IFN-free treatment strategies for F2-F4 and offered the greatest return on investment (0.899 LYs gained in SVR and 0.933 QALYs per €10,000 invested). CONCLUSION Comprehensive HCV screening and access to all-oral, IFN-free DAAs is a cost-effective strategy that could help diminish the upcoming burden of HCV in the French baby-boomer population.
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Affiliation(s)
- Olivier Ethgen
- a SERFAN innovation , Namur , Belgium
- b University of Liège , Liège , Belgium
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Ferreira PM, Guimarães RA, Souza CM, Guimarães LCDC, Barros CVDL, Caetano KAA, Rezza G, Spadoni L, Brunini SM. Exposure to hepatitis C virus in homeless men in Central Brazil: a cross-sectional study. BMC Public Health 2017; 17:90. [PMID: 28100196 PMCID: PMC5241983 DOI: 10.1186/s12889-016-3952-6] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2016] [Accepted: 12/15/2016] [Indexed: 12/22/2022] Open
Abstract
Background Homeless men are highly vulnerable to acquisition of the hepatitis C virus (HCV) compared to the general population. In Brazil, a country of continental dimensions, the extent of HCV infection in this population remains unknown. The objective of this study is to investigate the epidemiological profile of exposure to HCV in homeless men in Central Brazil. Methods A Cross-sectional study was conducted in 481 men aged over 18 years attending therapeutic communities specialized in the recovery and reintegration of homeless people. Participants were tested for anti-HCV markers using rapid tests. Poisson regression analysis was used to verify the risk factors associated with exposure to HCV. Results The prevalence of HCV exposure was 2.5% (95.0% CI: 1.4 to 4.3%) and was associated with age, absence of family life, injection drug use, number of sexual partners, and history of sexually transmitted infections (STI). Participants reported multiple risk behaviors, such as alcohol (78.9%), cocaine (37.1%) and/or crack use (53.1%), and inconsistent condom use (82.6%). Injection drug use was reported by 8.7% of participants. Conclusions The prevalence of HCV infection among homeless men was relatively high. Several risk behaviors were commonly reported, which shows the high vulnerability of this population. These findings emphasize the need for the development of specific strategies to reduce the risk of HCV among homeless men.
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Affiliation(s)
| | | | | | | | | | | | | | - Lila Spadoni
- Faculty of Psicology, UniEvangélica, Anápolis, Goiás, Brazil
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Geitona M, Kousoulakou H, Goulis I, Manolakopoulos S, Vasiliadis T, Christodoulou D, Gogos C, Dourakis S, George Koskinas I, Papadokostopoulou A, Lathouris A, Papatheodoridis G. Managing Hepatitis C Patients in Greece: A Budget Impact Analysis of Simeprevir plus Pegylated Interferon/Ribavirin Regimen at Early Stages of the Disease. Health (London) 2017. [DOI: 10.4236/health.2017.911109] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
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Petruzziello A, Marigliano S, Loquercio G, Cacciapuoti C. Hepatitis C virus (HCV) genotypes distribution: an epidemiological up-date in Europe. Infect Agent Cancer 2016; 11:53. [PMID: 27752280 PMCID: PMC5062817 DOI: 10.1186/s13027-016-0099-0] [Citation(s) in RCA: 51] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2016] [Accepted: 09/02/2016] [Indexed: 02/07/2023] Open
Abstract
Hepatitis C virus (HCV) infection is a major public health burden in Europe, causing an increasing level of liver-related morbidity and mortality, characterized by several regional variations in the genotypes distribution. A comprehensive review of the literature from 2000 to 2015 was used to gather country-specific data on prevalence and genotype distribution of HCV infection in 33 European countries (about 80 % of the European population), grouped in three geographical areas (Western, Eastern and Central Europe), as defined by the Global Burden of Diseases project (GBD). The estimated prevalence of HCV in Europe is 1.7 % showing a decrease than previously reported (− 0.6 %) and accounting over 13 million of estimated cases. The lowest prevalence (0.9 %) is reported from Western Europe (except for some rural areas of Southern Italy and Greece) and the highest (3.1 %) from Central Europe, especially Romania and Russia. The average HCV viraemic rate is 72.4 %, with a population of almost 10 million of HCV RNA positive patients. Genotype distribution does not show high variability among the three macro-areas studied, ranging between 70.0 % (Central Europe), 68.1 % (Eastern Europe) and 55.1 % (Western Europe) for genotype 1, 29.0 % (Western Europe), 26.6 % (Eastern Europe) and 21.0 % (Central Europe) for genotype 3. Genotype 2 seems, instead, to have a major prevalence in the Western Europe (8.9 %), if compared to Eastern (4.3 %) or Central (3.2 %), whereas genotype 4 is present especially in Central and Western area (4.9 % and 5.8 %, respectively). Despite the eradication of transmission by blood products, HCV infection continues to be one of the leading blood-borne infections in Europe. The aim of this review is, therefore, to provide an update on the epidemiology of HCV infection across Europe, and to foster the discussion about eventual potential strategies to eradicate it.
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Affiliation(s)
- Arnolfo Petruzziello
- Virology and Molecular Biology Unit "V. Tridente", Istituto Nazionale Tumori - Fondazione "G. Pascale", IRCCS Italia, Via Mariano Semmola, 80131 Naples, Italy
| | - Samantha Marigliano
- Virology and Molecular Biology Unit "V. Tridente", Istituto Nazionale Tumori - Fondazione "G. Pascale", IRCCS Italia, Via Mariano Semmola, 80131 Naples, Italy
| | - Giovanna Loquercio
- Virology and Molecular Biology Unit "V. Tridente", Istituto Nazionale Tumori - Fondazione "G. Pascale", IRCCS Italia, Via Mariano Semmola, 80131 Naples, Italy
| | - Carmela Cacciapuoti
- Virology and Molecular Biology Unit "V. Tridente", Istituto Nazionale Tumori - Fondazione "G. Pascale", IRCCS Italia, Via Mariano Semmola, 80131 Naples, Italy
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Croce D, Bonfanti M, Restelli U. Financial and feasibility implications of the treatment of hepatitis C virus in Italy: scenarios and perspectives. CLINICOECONOMICS AND OUTCOMES RESEARCH 2016; 8:377-85. [PMID: 27540306 PMCID: PMC4982504 DOI: 10.2147/ceor.s106769] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2023] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) affects an estimated number of people between 130 million and 210 million worldwide. In the next few years, the Italian National Health Service will face a growing trend of patients requiring HCV antiviral treatments. The aim of the analysis was to estimate the time horizon in which it would be possible to treat HCV-infected patients and the related direct medical costs (antiviral treatment and monitoring activities) from the Italian National Health Service point of view. METHODOLOGY In order to estimate the number of HCV-infected patients in Italy, we considered a top-down (considering published data) and a bottom-up approach. The number of years needed for treatment and related direct costs were estimated through the development of a static deterministic model. RESULTS The estimated number of HCV-infected patients in Italy varies from 2.7 (estimated through a top-down approach) to 0.6 million (estimated through a bottom-up approach) and 0.3 million (measured through a bottom-up approach). Considering the last two scenarios and the use of interferon-free therapies for 50,000 patients per year, treatment for HCV-infected patients could be at a cost of €13.7 billion and €7.0 billion by 2030 and 2023, respectively. CONCLUSION The treatment for HCV-infected patients in Italy is a challenging target for the financial implications of patient care. HCV infection could be controlled or eliminated in a 10- to 15-year time horizon. The cost of treatment can hardly be dealt with using the traditional economic tools but should be faced through multiyear investments, as health benefits are expected in the long period. National Health Service stakeholders (industry, government, insurance, and also patients) will have to identify suitable financial instruments to face the new expenditure required.
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Affiliation(s)
- Davide Croce
- Center for Research on Health Economics, Social and Health Care Management, Università Cattaneo, Castellanza, Italy
- School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
| | - Marzia Bonfanti
- Center for Research on Health Economics, Social and Health Care Management, Università Cattaneo, Castellanza, Italy
| | - Umberto Restelli
- Center for Research on Health Economics, Social and Health Care Management, Università Cattaneo, Castellanza, Italy
- School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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Meanwell NA. 2015 Philip S. Portoghese Medicinal Chemistry Lectureship. Curing Hepatitis C Virus Infection with Direct-Acting Antiviral Agents: The Arc of a Medicinal Chemistry Triumph. J Med Chem 2016; 59:7311-51. [PMID: 27501244 DOI: 10.1021/acs.jmedchem.6b00915] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
The development of direct-acting antiviral agents that can cure a chronic hepatitis C virus (HCV) infection after 8-12 weeks of daily, well-tolerated therapy has revolutionized the treatment of this insidious disease. In this article, three of Bristol-Myers Squibb's HCV programs are summarized, each of which produced a clinical candidate: the NS3 protease inhibitor asunaprevir (64), marketed as Sunvepra, the NS5A replication complex inhibitor daclatasvir (117), marketed as Daklinza, and the allosteric NS5B polymerase inhibitor beclabuvir (142), which is in late stage clinical studies. A clinical study with 64 and 117 established for the first time that a chronic HCV infection could be cured by treatment with direct-acting antiviral agents alone in the absence of interferon. The development of small molecule HCV therapeutics, designed by medicinal chemists, has been hailed as "the arc of a medical triumph" but may equally well be described as "the arc of a medicinal chemistry triumph".
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Affiliation(s)
- Nicholas A Meanwell
- Department of Discovery Chemistry, Bristol-Myers Squibb Research & Development , Wallingford, Connecticut 06492, United States
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Temporal dynamics of hepatitis C genotypes in a five-year hospital-based surveillance in Northern Italy. Arch Virol 2016; 161:2727-37. [DOI: 10.1007/s00705-016-2975-8] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2015] [Accepted: 07/06/2016] [Indexed: 02/06/2023]
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