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Ratiu IA, Mihaescu A, Olariu N, Ratiu CA, Cristian BG, Ratiu A, Indries M, Fratila S, Dejeu D, Teusdea A, Ganea M, Moisa C, Marc L. Hepatitis C Virus Infection in Hemodialysis Patients in the Era of Direct-Acting Antiviral Treatment: Observational Study and Narrative Review. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:2093. [PMID: 39768975 PMCID: PMC11678887 DOI: 10.3390/medicina60122093] [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: 11/26/2024] [Revised: 12/16/2024] [Accepted: 12/18/2024] [Indexed: 01/05/2025]
Abstract
Background and Objectives: Hepatitis C virus (HCV) infection is a major global public health concern, particularly in hemodialysis (HD) patients. This study aims to evaluate the demographic, clinical, and laboratory characteristics of HCV-positive patients undergoing HD and assess the long-term impact of direct-acting antivirals (DAAs) on patient outcomes. Moreover, a narrative review aims to summarize the current knowledge regarding HCV treatment in HD patients. The search in the PubMed, Google Scholar, and Scopus databases identified 48 studies relevant to our topic, 18 regarding clinical history and 29 related to HCV treatment. Methods: A retrospective analysis was performed on 165 HD patients from Bihor County HD centers, Romania, between 2014 and 2024. The cohort was divided into two groups: 54 patients who tested positive for HCV and 111 controls who were HCV-negative. Data collected from GPs included demographic information, comorbidities, laboratory parameters, and psychological assessments. Outcomes were evaluated at over 5 years after DAA treatment. A literature review was conducted using PubMed and Google Scholar to identify relevant studies on HCV in HD patients from 1989 to 2024. Results: Laboratory results showed similar parameters across groups, except for lower serum cholesterol levels in the HCV-positive DAA-treated group vs. HCV-positive non-treated ones (155.607 mg% vs. 170.174 mg%, p = 0.040) and increased ALT levels when comparing the same groups (29.107 vs. 22.261, p = 0.027), whereas comorbidities did not differ significantly. The incidence of malignancies was significantly higher among HCV-positive compared to HCV-negative patients (20.3% vs. 8.1%, p = 0.023), mainly among those treated with DAAs, highlighted by the multivariate analysis. Cardiovascular disease remains the leading cause of mortality regardless of HCV status or the use of antiviral therapy. Psychological assessments revealed more severe depression in HCV-positive patients compared to their HCV-negative counterparts. Conclusions: HCV infection in the hemodialysis population typically follows a subclinical course. At over five years after DAA therapy, the results indicate a stabilization of the liver function and the absence of major complications. However, the incidence of malignancies remains high in HCV-positive patients.
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Affiliation(s)
- Ioana Adela Ratiu
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
- Nephrology Department, Emergency Clinical Hospital Bihor County, 12 Corneliu Coposu Street, 410469 Oradea, Romania
| | - Adelina Mihaescu
- Department of Internal Medicine II—Division of Nephrology, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (A.M.); (N.O.); (L.M.)
- Center for Molecular Research in Nephrology and Vascular Disease, Faculty of Medicine, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timișoara, Romania
| | - Nicu Olariu
- Department of Internal Medicine II—Division of Nephrology, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (A.M.); (N.O.); (L.M.)
- Center for Molecular Research in Nephrology and Vascular Disease, Faculty of Medicine, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timișoara, Romania
| | - Cristian Adrian Ratiu
- Dentistry Department, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania;
| | - Bako Gabriel Cristian
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
- Nephrology Department, Emergency Clinical Hospital Bihor County, 12 Corneliu Coposu Street, 410469 Oradea, Romania
| | - Anamaria Ratiu
- Faculty of Dentistry, University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca, Victor Babeș 8, 400347 Cluj-Napoca, Romania;
| | - Mirela Indries
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
- Infectious Diseases Department, Emergency Clinical Hospital, 410167 Bihor County, Romania
| | - Simona Fratila
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
| | - Danut Dejeu
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
| | - Alin Teusdea
- Faculty of Environmental Protection, University of Oradea, G-ral Magheru 27, 410087 Oradea, Romania;
| | - Mariana Ganea
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
| | - Corina Moisa
- Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410073 Oradea, Romania; (I.A.R.); (B.G.C.); (M.I.); (S.F.); (D.D.); (M.G.)
| | - Luciana Marc
- Department of Internal Medicine II—Division of Nephrology, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (A.M.); (N.O.); (L.M.)
- Center for Molecular Research in Nephrology and Vascular Disease, Faculty of Medicine, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timișoara, Romania
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Chen R, Xiong Y, Zeng Y, Wang X, Xiao Y, Zheng Y. The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis. Front Public Health 2023; 11:1179531. [PMID: 37841743 PMCID: PMC10570741 DOI: 10.3389/fpubh.2023.1179531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2023] [Accepted: 08/31/2023] [Indexed: 10/17/2023] Open
Abstract
Background Hepatitis C virus (HCV) infection is an independent risk factor associated with adverse outcomes in patients with end-stage renal disease (ESRD). Due to the wide variety of direct-acting antiviral regimens (DAAs) and the factor of renal insufficiency, careless selection of anti-hepatitis C treatment can lead to treatment failure and safety problems. The integrated evidence for optimized therapies for these patients is lacking. This study would conduct comparisons of different DAAs and facilitate clinical decision-making. Methods We conducted a systematic literature search in multiple databases (PubMed, Ovid, Embase, Cochrane Library, and Web of Science) up to 7 August 2023. Study data that contained patient characteristics, study design, treatment regimens, intention-to-treat sustained virologic response (SVR), and adverse event (AE) data per regimen were extracted into a structured electronic database and analyzed. The network meta-analysis of the estimation was performed by the Bayesian Markov Chain Monte Carlo methods. Results Our search identified 5,278 articles; removing the studies with duplicates and ineligible criteria, a total of 62 studies (comprising 4,554 patients) were included. Overall, the analyses contained more than 2,489 male individuals, at least 202 patients with cirrhosis, and no less than 2,377 patients under hemodialysis. Network meta-analyses of the DAAs found that receiving ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (R) plus dasabuvir (DSV), glecaprevir (G)/pibrentasvir (P), and sofosbuvir (SOF)/ledipasvir (LDV) ranked as the top three efficacy factors for the HCV-infected ESRD patients. Stratified by genotype, the G/P would prioritize genotype 1 and 2 patients with 98.9%-100% SVR, the SOF/DCV regimen had the greatest SVR rates (98.7%; 95% CI, 93.0%-100.0%) in genotype 3, and the OBV/PTV/R regimen was the best choice for genotype 4, with the highest SVR of 98.1% (95% CI, 94.4%-99.9%). In the pan-genotypic DAAs comparison, the G/P regimen showed the best pooled SVR of 99.4% (95% CI, 98.6%-100%). DAA regimens without Ribavirin or SOF showed the lowest rates of AEs (49.9%; 95% CI, 38.4%-61.5%) in HCV-infected ESRD patients. Conclusion The G/P could be recommended as the best option for the treatment of pan-genotypic HCV-infected ESRD patients. The OBV/PTV/R plus DSV, SOF/Velpatasvir (VEL), SOF/Ledipasvir (LDV), and SOF/DCV would be reliable alternatives for HCV treatment with comparable efficacy and safety profiles. Systematic review registration https://www.crd.york.ac.uk/prospero/#searchadvanced, PROSPERO: CRD42021242359.
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Affiliation(s)
- Ruochan Chen
- Key Laboratory of Viral Hepatitis of Hunan, Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China
- National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China
| | - Yinghui Xiong
- Department of Respiration, Hunan Children's Hospital, Changsha, China
| | - Yanyang Zeng
- Key Laboratory of Viral Hepatitis of Hunan, Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China
- National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China
| | - Xiaolei Wang
- Hunan Provincial Center for Disease Control and Prevention, Hunan Workstation for Emerging Infectious Disease Control and Prevention, Chinese Academy of Medical Sciences, Changsha, China
| | - Yinzong Xiao
- Burnet Institute, St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia
| | - Yixiang Zheng
- Key Laboratory of Viral Hepatitis of Hunan, Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China
- National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China
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Hagag RS, Fakhry MM, Ahmed OA, Abdalgeleel SA, Radwan MA, Naguib GG. Assessment of efficacy and safety of two Egyptian protocols for treatment-experienced HCV patients: an observational study. THE EGYPTIAN JOURNAL OF INTERNAL MEDICINE 2022. [DOI: 10.1186/s43162-022-00126-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
Abstract
Background
The devastating adverse effects of interferon (IFN) for the treatment of hepatitis C virus (HCV) lead to the emerging of direct acting antiviral agents (DAAs). This investigation was undertaken to assess safety and efficacy of two Egyptian DAA protocols for HCV: sofosbuvir (SOF)/daclatasvir (DCV)/simeprevir (SMV)/ribavirin (RBV) and sofosbuvir (SOF)/ombitasvir (OMB)/paritaprevir (PTV)/ritonavir (RTV)/RBV for 12 weeks in treatment-experienced HCV Egyptian patients.
Methods
It is a retrospective study where 139 patients, out of 400 patients, were divided according to their documented treatment protocol into two groups (Gp1: SOF/DCV/SMV/RBV and Gp2: SOF/PTV/OMB/RTV/RBV). All patients’ physical examination, disease history, laboratory baseline, and end of treatment data were collected from their profiles, evaluated and compared.
Results
Gp1 and Gp2 regimens had achieved sustained virologic response rates (SVR12) of 96.6% and 95.1%, respectively. Hemoglobin, ALT, and AST had decreased significantly (P < 0.05) in the two groups. Total bilirubin level had increased significantly in Gp1 and Gp2 (P = 0.002 and < 0.001, respectively). Creatinine level had increased significantly (P = 0.002) in Gp1 at end of treatment, while Gp2 remained unchanged. Headache and fatigue were the most common side effects in both protocols.
Conclusions
SOF/DCV/SMV/RBV and SOF/PTV/OMB/RTV/RBV regimens achieved high similar efficacy in Egyptian treatment-experienced HCV patients. Even though the outcome was with tolerable side effects, a better treatment regimen was recommended to abate these side effects for the welfare of Egyptian HCV patients.
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Fabrizi F, Cerutti R, Dixit V, Ridruejo E. Sofosbuvir-based regimens for HCV in stage 4-stage 5 chronic kidney disease. A systematic review with meta-analysis. Nefrologia 2021; 41:578-589. [PMID: 36165141 DOI: 10.1016/j.nefroe.2021.11.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2020] [Accepted: 01/18/2021] [Indexed: 06/16/2023] Open
Abstract
BACKGROUND Hepatitis C is an important agent of liver damage in patients with chronic kidney disease and the advent of DAAs has dramatically changed the management of HCV positive patients, including those with advanced CKD. Sofosbuvir is the backbone of many anti-HCV regimens based on DAAs but it remains unclear whether it is appropriate for HCV-infected patients with stage 4-5 CKD. STUDY AIMS AND DESIGN We performed a systematic review of the literature with a meta-analysis of clinical studies in order to evaluate the efficacy and safety of SOF-based DAA regimens in patients with stage 4-5 CKD. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcomes were the frequency of SAEs and drop-outs due to AEs (as measures of tolerability). The random-effects model of DerSimonian and Laird was adopted, with heterogeneity and stratified analyses. RESULTS Thirty clinical studies (n=1537 unique patients) were retrieved. The pooled SVR12 and SAEs rate was 0.99 (95% confidence intervals, 0.97; 1.0, I2=99.8%) and 0.09 (95% CI, 0.05; 0.13, I2=84.3%), respectively. The pooled SVR12 rate in studies with high HCV RNA levels at baseline was lower, 0.87 (95% CI, 0.75; 1.0, I2=73.3%) (P<0.001). The pooled drop-out rate due to AEs was 0.02 (95% CI, -0.01; 0.04, I2=16.1%). Common serious adverse events were anemia (n=26, 38%) and reduced eGFR (n=14, 19%). SAEs were more common in studies adopting full-dose sofosbuvir (pooled rate of SAEs 0.15, 95% CI, 0.06; 0.25; I2=80.1%) and in those based on ribavirin (0.15, 95% CI, 0.07; 0.23, I2=95.8%). Six studies (n=69 patients) reported eGFR levels at baseline/post- antiviral therapy; no consistent changes were found. CONCLUSIONS SOF-based regimens appear safe and effective in patients with stage 4-5 CKD. Serum creatinine should be carefully monitored during therapy with SOF in patients with CKD. Randomized controlled studies in order to expand our knowledge on this point are under way.
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Affiliation(s)
- Fabrizio Fabrizi
- Division of Nephrology, Dialysis and Transplantation IRCCS Ca Granda Foundation and Maggiore Polyclynic Hospital, Milano, Italy.
| | - Roberta Cerutti
- Division of Nephrology, Dialysis and Transplantation IRCCS Ca Granda Foundation and Maggiore Polyclynic Hospital, Milano, Italy
| | - Vivek Dixit
- Division of Digestive Diseases, UCLA School of Medicine, CA, USA
| | - Ezequiel Ridruejo
- Hepatology Section, Department of Medicine, Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autonoma de Buoenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina
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Frankova S, Jandova Z, Jinochova G, Kreidlova M, Merta D, Sperl J. Therapy of chronic hepatitis C in people who inject drugs: focus on adherence. Harm Reduct J 2021; 18:69. [PMID: 34193156 PMCID: PMC8247095 DOI: 10.1186/s12954-021-00519-y] [Citation(s) in RCA: 20] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2020] [Accepted: 06/22/2021] [Indexed: 12/31/2022] Open
Abstract
Background Intravenous drug use (IVDU) represents the major factor of HCV transmission, but the treatment uptake among people who inject drugs (PWID) remains low owing to a false presumption of low efficacy. The aim of our study was to assess treatment efficacy in PWID and factors determining adherence to therapy. Methods A total of 278 consecutive patients starting DAA (direct-acting antivirals) therapy were included, divided into two groups: individuals with a history of IVDU, PWID group (N = 101) and the control group (N = 177) without a history of IVDU. Results Sustained virological response 12 weeks after the end of therapy (SVR12) was achieved by 99/101 (98%) and 172/177 (98%) patients in the PWID and control group, respectively; in PWID group, two patients were lost to follow-up, and in the control group, four patients relapsed and one was lost to follow-up. PWID patients postponed appointments significantly more often, 29 (28.7%) in PWID versus 7 (4%) in the control group, p = 0.001. Thirteen of 101 (12.9%) and six of 177 (3.4%) patients in the PWID and in the control group, respectively, missed at least one visit (p < 0.01). However, postponing visits led to a lack of medication in only one PWID. In the PWID group, older age (p < 0.05; OR 1.07, 95% CI 1.00–1.20) and stable housing (p < 0.01; OR 9.70, 95% CI 2.10–56.20) were factors positively contributing to adherence. Contrarily, a stable job was a factor negatively influencing adherence (p < 0.05; OR 0.24, 95% CI 0.06–0.81). In the control group, none of the analyzed social and demographic factors had an impact on adherence to therapy. Conclusions In PWID, treatment efficacy was excellent and was comparable with SVR of the control group. Stable housing and older age contributed to a better adherence to therapy.
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Affiliation(s)
- Sona Frankova
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 14021, Prague, Czech Republic.
| | - Zuzana Jandova
- Psychiatric Hospital Havlickuv Brod, Havlickuv Brod, Czech Republic.,First Faculty of Medicine, Charles University, Prague, Czech Republic
| | - Gabriela Jinochova
- Psychiatric Hospital Havlickuv Brod, Havlickuv Brod, Czech Republic.,Addiction Centre Prague, Prague, Czech Republic
| | - Miluse Kreidlova
- Institute of Medical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine Charles University and General University Hospital in Prague, Prague, Czech Republic
| | - Dusan Merta
- Cardiothoracic Anaesthesiology and Intensive Care, Department of Anaesthesiology and Intensive Care Medicine, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Jan Sperl
- Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 14021, Prague, Czech Republic.,First Faculty of Medicine, Charles University, Prague, Czech Republic
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Fabrizi F, Cerutti R, Dixit V, Ridruejo E. Sofosbuvir-based regimens for HCV in stage 4-stage 5 chronic kidney disease. A systematic review with meta-analysis. Nefrologia 2021. [PMID: 34154846 DOI: 10.1016/j.nefro.2021.01.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022] Open
Abstract
BACKGROUND Hepatitis C is an important agent of liver damage in patients with chronic kidney disease and the advent of DAAs has dramatically changed the management of HCV positive patients, including those with advanced CKD. Sofosbuvir is the backbone of many anti-HCV regimens based on DAAs but it remains unclear whether it is appropriate for HCV-infected patients with stage 4-5 CKD. STUDY AIMS AND DESIGN We performed a systematic review of the literature with a meta-analysis of clinical studies in order to evaluate the efficacy and safety of SOF-based DAA regimens in patients with stage 4-5 CKD. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcomes were the frequency of SAEs and drop-outs due to AEs (as measures of tolerability). The random-effects model of DerSimonian and Laird was adopted, with heterogeneity and stratified analyses. RESULTS Thirty clinical studies (n=1537 unique patients) were retrieved. The pooled SVR12 and SAEs rate was 0.99 (95% confidence intervals, 0.97; 1.0, I2=99.8%) and 0.09 (95% CI, 0.05; 0.13, I2=84.3%), respectively. The pooled SVR12 rate in studies with high HCV RNA levels at baseline was lower, 0.87 (95% CI, 0.75; 1.0, I2=73.3%) (P<0.001). The pooled drop-out rate due to AEs was 0.02 (95% CI, -0.01; 0.04, I2=16.1%). Common serious adverse events were anemia (n=26, 38%) and reduced eGFR (n=14, 19%). SAEs were more common in studies adopting full-dose sofosbuvir (pooled rate of SAEs 0.15, 95% CI, 0.06; 0.25; I2=80.1%) and in those based on ribavirin (0.15, 95% CI, 0.07; 0.23, I2=95.8%). Six studies (n=69 patients) reported eGFR levels at baseline/post- antiviral therapy; no consistent changes were found. CONCLUSIONS SOF-based regimens appear safe and effective in patients with stage 4-5 CKD. Serum creatinine should be carefully monitored during therapy with SOF in patients with CKD. Randomized controlled studies in order to expand our knowledge on this point are under way.
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Affiliation(s)
- Fabrizio Fabrizi
- Division of Nephrology, Dialysis and Transplantation IRCCS Ca Granda Foundation and Maggiore Polyclynic Hospital, Milano, Italy.
| | - Roberta Cerutti
- Division of Nephrology, Dialysis and Transplantation IRCCS Ca Granda Foundation and Maggiore Polyclynic Hospital, Milano, Italy
| | - Vivek Dixit
- Division of Digestive Diseases, UCLA School of Medicine, CA, USA
| | - Ezequiel Ridruejo
- Hepatology Section, Department of Medicine, Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autonoma de Buoenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina
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The Efficacy and Safety of Sofosbuvir/Daclatasvir Fixed-Dose Combination in Iranian Hemodialysis Patients with Hepatitis C Virus Infection. Nephrourol Mon 2021. [DOI: 10.5812/numonthly.114049] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
Background: Although several regimens have been approved for the treatment of hepatitis C virus (HCV) infection, sofosbuvir-based regimens are not approved for the treatment of HCV infection in patients with severe renal impairment. Methods: This study was conducted on hemodialysis patients infected with HCV. The patients received a constant dose of sofosbuvir/daclatasvir (SOF/DCV). Sustained virologic response (SVR) was evaluated 12 weeks after completion of treatment. Results: Fifty-one hemodialysis patients with HCV infection were selected and treated with a combination of SOF/DCV. Eleven patients expired during the anti-HCV treatment due to causes not related to liver disease or antiviral therapy. Finally, 40 patients finished the treatment, and 36 cases were evaluated for SVR. Among those tested for SVR, 35 (97.2%, 95% CI: 85.5 - 99.9%) achieved SVR and one (2.8%, 95% CI: 0.1 - 14.5%) relapsed. No patient reported severe adverse events. Conclusions: The combination of SOF/DCV showed great efficacy and safety in hemodialysis patients with severe renal impairment and chronic HCV infection.
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An updated systematic review and meta-analysis on efficacy of Sofosbuvir in treating hepatitis C-infected patients with advanced chronic kidney disease. PLoS One 2021; 16:e0246594. [PMID: 33566846 PMCID: PMC7875415 DOI: 10.1371/journal.pone.0246594] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2020] [Accepted: 01/22/2021] [Indexed: 12/20/2022] Open
Abstract
Sofosbuvir seems to be a revolutionary treatment for Hepatitis C-infected patients with advanced chronic kidney disease (CKD) but existing evidence is not quite adequate. The aim of this study was to evaluate the efficacy and safety of Sofosbuvir-based therapy without Ribavirin for all hepatitis C virus genotypes among patients with advanced CKD. We conducted an updated systematic literature search from the beginning of 2013 up to June 2020. Sustained virologic response (SVR) rate at 12 and/or 24 weeks after the end of treatment, and adverse events in HCV-infected patients with advanced CKD were pooled using random effects models. We included 27 published articles in our meta-analyses, totaling 1,464 HCV-infected patients with advanced CKD. We found a substantial heterogeneity based on the I2 index (P = 0.00, I2 = 56.1%). The pooled SVR rates at 12 and 24 weeks after the end of Sofosbuvir-based treatment were 97% (95% Confidence Interval: 95-99) and 95% (89-99) respectively. The pooled SVR12 rates were 98% (96-100) and 94% (90-97) in patients under 60 and over 60 years old respectively. The pooled incidence of severe adverse events was 0.11 (0.04-0.19). The pooled SVR12 rate after completion of the half dose regimen was as high as the full dose treatment but it was associated with less adverse events (0.06 versus 0.14). The pooled SVR12 rate was 98% (91-100) in cirrhotic patients and 100% (98-100) in non-cirrhotic patients. The endorsement of Sofosbuvir-based regimen can improve the treatment of hepatitis C virus infection in patients with advanced CKD.
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Shehadeh F, Kalligeros M, Byrd K, Shemin D, Mylonakis E, Martin P, D'Agata EMC. Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis. Sci Rep 2020; 10:14332. [PMID: 32868869 PMCID: PMC7459301 DOI: 10.1038/s41598-020-71205-5] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2020] [Accepted: 08/10/2020] [Indexed: 12/12/2022] Open
Abstract
Hepatitis C virus (HCV) infection among maintenance hemodialysis patients is implicated in increased morbidity and mortality compared to uninfected patients. Sofosbuvir (SOF)-based regimens may not be optimal among patients requiring hemodialysis. Several studies, however, provide evidence that use of SOF among HCV-positive patients with renal impairment, is effective and safe. We searched Pubmed and Embase to identify studies reporting the efficacy and safety of SOF-based regimens for the treatment of HCV-positive patients on maintenance hemodialysis and performed a random effects meta-analysis. The overall pooled estimate of the efficacy of SOF-based therapy was 95% (95% CI 91–98%). The efficacy of the SOF-based regimen was 92% (95% CI 80–99%), 98% (95% CI 96–100%), and 100% (95% CI 95–100%) for the following doses: 400 mg on alternate days, 400 mg daily, and 200 mg daily, respectively. The most frequent adverse event was fatigue with a pooled prevalence of 16% (95% CI 5–29%), followed by anemia 15% (95% CI 3–31%), and nausea or vomiting 14% (95% CI 4–27%). Anemia was more prevalent in treatment regimens containing ribavirin (46%, 95% CI 33–59%) compared to ribavirin-free regimens (3%, 95% CI 0–9%). This study suggests that SOF-based regimens in the treatment of HCV infection among hemodialysis patients are both effective and safe.
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Affiliation(s)
- Fadi Shehadeh
- Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, POB 328, Providence, RI, USA.
| | - Markos Kalligeros
- Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, POB 328, Providence, RI, USA
| | - Katrina Byrd
- Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, POB 328, Providence, RI, USA
| | - Douglas Shemin
- Kidney Disease Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI, USA
| | - Eleftherios Mylonakis
- Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, POB 328, Providence, RI, USA
| | - Paul Martin
- Division of Digestive Health and Liver Disease, Miller School of Medicine, University of Miami, Miami, FL, USA
| | - Erika M C D'Agata
- Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, POB 328, Providence, RI, USA
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10
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Ibrahim Mohammed Ebid AH, Ashraf Ahmed O, Hassan Agwa S, Mohamed Abdel-Motaleb S, Mohamed Elsawy A, Hagag RS. Safety, efficacy and cost of two direct-acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients. J Clin Pharm Ther 2019; 45:539-546. [PMID: 31889322 DOI: 10.1111/jcpt.13104] [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: 09/29/2019] [Revised: 11/26/2019] [Accepted: 11/29/2019] [Indexed: 12/16/2022]
Abstract
WHAT IS KNOWN AND OBJECTIVE Direct-acting antivirals (DAAs) have become the most widely used treatment of chronic hepatitis C infection. Comparative studies on DAAs regimens approved by the Egyptian Ministry of Health for easy-to-treat genotype 4 (G4) Egyptian patients are still deficient. In this prospective study, we compared the efficacy and cost of two DAA regimens that are used in the treatment of Egyptian chronic hepatitis C virus (HCV) G4. The cost-saving regimen is determined. METHODS Eligible patients were randomized into 2 groups. Group 1 (Gp 1) received sofosbuvir plus daclatasvir, and group 2 (Gp 2) received ombitasvir, paritaprevir and ritonavir plus ribavirin (RBV) for 12 weeks. Data were collected and evaluated at baseline and at weeks 4, 8 and 12. Sustained virologic response 12 weeks after the end of treatment (SVR12 ) was evaluated. Cost-minimization analysis (CMA) was performed. RESULTS AND DISCUSSION Eligibility was achieved in 107 patients, Gp1 included 57 patients, and Gp 2 included 50 patients. Two patients dropped out from Gp 2 due to non-compliance. All patients in the two groups showed negative HCV blood levels at the end of treatment. At the 24th week, 3 relapsers (5.2%) were detected in Gp1 and 2 relapsers (4.1%) were detected in Gp 2. SVR12 was 54/57 (94.7%) and 46/48 (95.8%) for Gp 1 and Gp 2, respectively. After the 12th week of treatment, a significant decrease in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and haemoglobin levels were observed in both groups. Albumin levels declined in Gp 2 only. CMA showed higher cost in Gp 2 than Gp 1, although similar efficacy and safety. WHAT IS NEW AND CONCLUSION The two DAA regimens showed high SVR12 and safety in Egyptian HCV G4 patients. Sofosbuvir plus daclatasvir is the cost-saving regimen.
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Affiliation(s)
| | - Osama Ashraf Ahmed
- Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt
| | - Sara Hassan Agwa
- Department of Clinical & Chemical Pathology at MASRI, Faculty of Medicine, Ain Shams University, Cairo, Egypt
| | | | - Amira Mohamed Elsawy
- Department of Pharmacy Practice, Faculty of Pharmacy, Helwan University, Cairo, Egypt
| | - Radwa Samir Hagag
- Department of Pharmacy Practice, Faculty of Pharmacy, Egyptian Russian University, Badr City, Egypt
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11
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Habashy NH, Abu-Serie MM. Major royal-jelly protein 2 and its isoform X1 are two novel safe inhibitors for hepatitis C and B viral entry and replication. Int J Biol Macromol 2019; 141:1072-1087. [DOI: 10.1016/j.ijbiomac.2019.09.080] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2019] [Revised: 08/31/2019] [Accepted: 09/10/2019] [Indexed: 02/07/2023]
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12
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Colombo MG, Musabaev EI, Ismailov UY, Zaytsev IA, Nersesov AV, Anastasiy IA, Karpov IA, Golubovska OA, Kaliaskarova KS, AC R, Hadigal S. Consensus on management of hepatitis C virus infection in resource-limited Ukraine and Commonwealth of Independent States regions. World J Gastroenterol 2019; 25:3897-3919. [PMID: 31413526 PMCID: PMC6689802 DOI: 10.3748/wjg.v25.i29.3897] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2019] [Revised: 06/04/2019] [Accepted: 06/08/2019] [Indexed: 02/06/2023] Open
Abstract
Globally, 69.6 million individuals were infected with hepatitis C virus (HCV) infection in 2016. Of the six major HCV genotypes (GT), the most predominant one is GT1, worldwide. The prevalence of HCV in Central Asia, which includes most of the Commonwealth of Independent States (CIS), has been estimated to be 5.8% of the total global burden. The predominant genotype in the CIS and Ukraine regions has been reported to be GT1, followed by GT3. Inadequate HCV epidemiological data, multiple socio-economic barriers, and the lack of region-specific guidelines have impeded the optimal management of HCV infection in this region. In this regard, a panel of regional experts in the field of hepatology convened to discuss and provide recommendations on the diagnosis, treatment, and pre-, on-, and posttreatment assessment of chronic HCV infection and to ensure the optimal use of cost-effective antiviral regimens in the region. A comprehensive evaluation of the literature along with expert recommendations for the management of GT1-GT6 HCV infection with the antiviral agents available in the region has been provided in this review. This consensus document will help guide clinical decision-making during the management of HCV infection, further optimizing treatment outcomes in these regions.
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Affiliation(s)
- Massimo Giuseppe Colombo
- Research and Clinical Center, Department of Medicine, Humanitas Hospital, Rozzano 20089, MI, Italy
| | - Erkin Isakovich Musabaev
- Research Institute of Virology, Scientific Research Institute of Virology, Tashkent 100194, Uzbekistan
| | - Umed Yusupovich Ismailov
- Hepatoсenter, Research Institute of Virology, Scientific Research Institute of Virology, Tashkent 100194, Uzbekistan
| | - Igor A Zaytsev
- Department of Therapy, Infectious Diseases and Dermatology, Bogomolets National Medical University, Kyiv 01601, Ukraine
| | - Alexander V Nersesov
- Department of Gastroenterology and Hepatology, National Research Institute of Cardiology and Internal Diseases, Almaty 050000, Kazakhstan
| | | | | | - Olga A Golubovska
- Department Infectious Diseases, Bogomolets National Medical University, Kyiv 01601, Ukraine
| | | | - Ravishankar AC
- Medical Affairs, Mylan Pharmaceuticals Private Limited, Kadubeesanahalli, Bengaluru 560103, India
| | - Sanjay Hadigal
- Medical Affairs, Mylan Pharmaceuticals Private Limited, Kadubeesanahalli, Bengaluru 560103, India
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13
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Elmowafy AY, El Maghrabi HM, Eldahshan KF, Refaie AF, Elbasiony MA, Matter YE, Saleh HH, Shiha GE, Rostaing L, Bakr MA. Treatment of hepatitis C infection among Egyptian hemodialysis patients: the dream becomes a reality. Int Urol Nephrol 2019; 51:1639-1647. [PMID: 31363959 DOI: 10.1007/s11255-019-02246-7] [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: 02/24/2019] [Accepted: 07/21/2019] [Indexed: 01/07/2023]
Abstract
BACKGROUND AND AIMS New direct-acting antiviral drugs have become the corner-stone treatment for HCV infection: they show promising results with accepted side-effects and low dropout rates. One of the available regimens is paritaprevir/ombitasvir/ritonavir (PTV/OMV/RTV). Our aim was to study the efficacy and safety of this drug regimen among HCV-positive hemodialysis patients. METHODS This prospective single-center study was performed in the Urology and Nephrology Center, Mansoura University, Egypt. Ninety-six maintenance hemodialysis patients were screened for HCV antibodies. Positive results were found in 46 patients (47.9%). HCV PCR was assessed in all HCV-antibody-positive patients; positive results were found positive for 38 (82%); all patients were HCV genotype 4. Four patients were excluded due to advanced liver cirrhosis, liver malignancy, or metastatic breast cancer. Thirty-four patients were prescribed PTV/OMV/RTV for 3 months to treat HCV. RESULTS Mean age was 43.2 ± 11.9 years. Most patients were male (67.6%). There was a rapid response to treatment: HCV PCR became negative by 4 weeks after starting treatment. By 12 and 24 weeks post-DAA therapy, there was a sustained viral response (SVR 12, SVR 24) in 100% of patients with improved liver-enzyme levels. CONCLUSION The PTV/OMV/RTV regimen was safe and effectively treated Egyptian HCV-positive genotype-4 hemodialysis patients.
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Affiliation(s)
| | - Hanzada Mohamed El Maghrabi
- Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.,Nephrology Department, Port-Said University, Port Fuad, Egypt
| | | | | | - Mohammed Adel Elbasiony
- Egyptian Liver Research Institute and Hospital, Mansoura, Egypt.,Internal Medicine Department, Mansoura University, Mansoura, Egypt
| | | | | | | | - Lionel Rostaing
- Service de Néphrologie, Dialyse, Aphérèses et Transplantation Rénale, CHU Grenoble Alpes, CS 10217, 38043, Grenoble Cedex 09, France.
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14
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Han Q, Fan X, Wang X, Wang Y, Deng H, Zhang X, Zhang K, Li N, Liu Z. High sustained virologic response rates of sofosbuvir-based regimens in Chinese patients with HCV genotype 3a infection in a real-world setting. Virol J 2019; 16:74. [PMID: 31159813 PMCID: PMC6547524 DOI: 10.1186/s12985-019-1184-y] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2019] [Accepted: 05/24/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Patients with hepatitis C virus (HCV) genotype 3 infection remain a difficult-to-cure population. This study evaluated the efficacy and safety of sofosbuvir-based regimen in genotype 3 patients in a real-world setting. METHODS HCV genotype 3a-infected adults with compensated liver disease were treated with sofosbuvir (SOF)/velpatasvir (VEL) or SOF/daclatasvir (DCV) with or without ribavirin (RBV) for 12 or 24 weeks, respectively. Efficacy was measured by sustained virologic response at post-treatment week 12 (SVR12). Adverse events were evaluated throughout the treatment and follow-up course. RESULTS A total of 41 genotype 3a-infected patients were included. Of them, 10 patients (24%) had cirrhosis, 3 (7%) had renal impairment, and 2 (5%) failed previous treatment. Nine patients (22%) were treated with SOF/VEL and 32 (78%) with SOF/DCV with or without RBV. SVR 12 was achieved in 100% (9/9) of patients treated with SOF/VEL for 12 weeks and in 97% (31/32) of those treated with SOF/DCV for 12 or 24 weeks. RBV addition and extension of treatment duration did not improve the SVR of SOF/DCV (RR: 1.04; P = 0.99 and RR: 1.09; P = 0.375, respectively). Ten patients with cirrhosis, 1 on hemodialysis and 2 with treatment-experience achieved SVR12. One treatment-naïve non-cirrhotic patient on hemodialysis treated with SOF/DCV for 24 weeks relapsed at week 8 post-treatment. No serious adverse events and relevant laboratory abnormalities were observed. CONCLUSION SOF/VEL and SOF/DCV are highly efficacious and well tolerated in genotype 3a-infected patients with or without cirrhosis. RBV coadministration and extension of SOF/DCV treatment appear to add no improvement for efficacy.
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Affiliation(s)
- Qunying Han
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Xiude Fan
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Xiaoyun Wang
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Ye Wang
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Huan Deng
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Xiaoge Zhang
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Kun Zhang
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Na Li
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
| | - Zhengwen Liu
- Department of Infectious Diseases, First Affiliated Hospital of Xi’an Jiaotong University, No. 277 Yanta West Road, Xi’an, 710061 Shaanxi Province People’s Republic of China
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15
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Hepatitis C virus antibodies in outpatients with chronic kidney disease. Clin Exp Hepatol 2018; 4:267-270. [PMID: 30603675 PMCID: PMC6311740 DOI: 10.5114/ceh.2018.80129] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2018] [Accepted: 06/10/2018] [Indexed: 11/17/2022] Open
Abstract
Aim of the study To determine the seroprevalence of hepatitis C virus (HCV) in outpatients with chronic kidney disease (CKD) attending a nephrology clinic. Material and methods Prospective observational study on consecutive outpatients attending a nephrology clinic. Inclusion criteria were age > 18 years, CKD, informed consent. There were no exclusion criterias. Recorded variables were age, gender, CKD grade and etiology, anti-HCV antibodies (Ab). Patients with positive HCV Abs were tracked for HCV RNA detection. Study interval was from November 2015 to March 2016. The study has been approved by the Ethic committee of F.D. Roosevelt University Hospital. Funded by Restricted Grant of AbbVie Slovakia. Results One hundred and thirty-four patients were enrolled, with median age 70 years (19.7-91), 52% women. CKD grades: G1/2 – 52 patients (39%), G3a – 34 patients (25%), G3b – 32 patients (24%), G4 – 8 patients (6%), G5 – 8 patients (6%); CKD etiology: tubulointerstitial nephritis (TIN) – 53 patients (40%), nephrosclerosis (NS) – 30 patients (22%), diabetic nephropathy (DN) – 23 patients (17%), glomerulonephritis (GN) – 23 patients (17%), others – 5 patients (4%). Anti-HCV antibodies were detected in 8 patients (6%). There were no significant differences in CKD grades between HCV+ and HCV– patients; Heymann nephritis and GN were significantly more frequent in HCV– patients, as was male gender. Of 8 HCV Ab positive patients, 5 were available for HCV RNA testing (2 died after completion of the study, 1 was lost to follow-up); of them, 1 patient tested positive. Conclusions Prevalence of anti-HCV antibodies in CKD patients was 6%, which is 4 times higher than in the general population of Slovakia; HCV RNA was detected in 1 patient (12.5%) of anti-HCV positive patients. Based on this result, multicentric, a larger-scale study is considered to be warranted.
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16
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Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease. Dig Dis Sci 2018; 63:1334-1340. [PMID: 29484572 DOI: 10.1007/s10620-018-4979-6] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2017] [Accepted: 02/12/2018] [Indexed: 12/23/2022]
Abstract
BACKGROUND AND AIMS There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2. We evaluated the safety and efficacy of low-dose Sofosbuvir plus full-dose Daclatasvir in CHC patients with CKD. METHODS Sixty-five CHC patients with CKD with eGFR less than 30 mL/min/1.73 m2 [54 (83%) patients with ESRD on hemodialysis] were included. All patients irrespective of genotype were treated with half-dose Sofosbuvir [200 mg (half tablet of 400 mg)] plus full-dose Daclatasvir (60 mg) given daily for either 12 or 24 weeks given in patients with genotype 3 cirrhosis. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). RESULTS The median HCV RNA level in 65 patients (Males 40, mean age 42.9 ± 13 years) was 1.65 × 106 (1.2 × 103-1.73 × 108) IU/mL with 42 (64.6%) patients having HCV genotype 1, followed by genotype 3 and 2 in 22 (34%) and 1 (1.4%) patients, respectively. Twenty-one (32%) patients had evidence of cirrhosis, and ten (15.4%) patients were treatment experienced. Sixty-four (98.5%) patients achieved ETR, and 65 (100%) patients attained SVR12. All patients tolerated the DAAs well with none of the patients reporting any serious adverse events. Minor side effects noted were nausea seen in five (7.7%) patients, insomnia and headache in four (6.2%) patients each, and pruritus in one (1.5%) patient. CONCLUSION Low-dose Sofosbuvir and full-dose Daclatasvir are safe and effective in treating CHC in patients with CKD with eGFR less than 30 mL/min/1.73 m2.
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