Dataset Information

Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.

ABSTRACT: Hepatitis C Virus (HCV) infection is major health problem worldwide, with 150 million infected people according to recent epidemiologic estimations. The introduction of direct-acting antivirals made a revolutionary change in the management of HCV infected patients with surprisingly high rates of antiviral response, improved tolerability and reduced time of treatment. Sofosbuvir, in combination with different partner drugs, has been the molecule that led this incredible change. The last generation of SOF-based regimens, namely Sofosbuvir/Velpatasvir, represents a single tablet, once a day, pangenotypic and pan-fibrotic combination, demonstrated to be safe and effective in almost all type of HCV infected individuals. This review overviews the main clinical data of SOF/VEL registration trials, underlying the key features of this combination in terms of efficacy, safety and Patients Reported Outcomes obtained in more than 1800 HCV chronically infected subjects.

SUBMITTER: Zignego AL

PROVIDER: S-EPMC6502110 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.

Zignego Anna Linda AL Monti Monica M Gragnani Laura L

Acta bio-medica : Atenei Parmensis 20181008 3

Hepatitis C Virus (HCV) infection is major health problem worldwide, with 150 million infected people according to recent epidemiologic estimations. The introduction of direct-acting antivirals made a revolutionary change in the management of HCV infected patients with surprisingly high rates of antiviral response, improved tolerability and reduced time of treatment. Sofosbuvir, in combination with different partner drugs, has been the molecule that led this incredible change. The last generatio ...[more]

PMID: 30333452

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Project description:Background & aimsShortened duration therapy for acute and recent HCV infection has been shown to be highly effective in several small non-randomised studies with direct-acting antiviral regimens; however, large randomised studies are lacking.MethodsREACT was an NIH-funded multicentre international, open-label, randomised, phase IV non-inferiority trial examining the efficacy of short course (6-week) vs. standard course (12-week) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection ≤12 months). Randomisation occurred at week 6. The primary endpoint was sustained virological response 12 weeks after treatment end (SVR12) in the intention-to treat (ITT) population. A total of 250 participants were due to be enrolled, but on advice of the data safety and monitoring board the study was halted early.ResultsThe primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n = 93), standard arm (n = 95). Ninety-seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4-89.0) in the short arm and 86/95, 90.5% (95% CI 82.7-95.6) in the standard arm. The difference between the arms was -8.8 (95% CI -18.6 to 1.0). In modified ITT analysis, wherein non-virological reasons for failure were excluded (death, reinfection, loss to follow-up), SVR12 was 76/85, 89.4% (95% CI 80.8-95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0-99.7; difference -8.3%, p = 0.025).ConclusionsIn this randomised study in recent HCV infection, a 6-week course of sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12-week therapy.Lay summaryIn this randomised trial, 188 people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were 9 cases of relapse after treatment with the short course and 2 following the standard course. A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C infection. CLINICALTRIALS.Gov identifierNCT02625909.

Project description:IntroductionPangenotypic direct-acting antivirals are expected to cure hepatitis C virus (HCV) in more than 95% of treated patients. However, data on the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) in Taiwan are limited. This study aims to characterize the patient population in the nationwide Taiwan Association for the Study of the Liver (TASL) HCV Registry and evaluate treatment outcome in Taiwanese patients receiving SOF/VEL.MethodsThis study was a retrospective-prospective, observational, multicenter, real-world analysis. Adults with chronic hepatitis C were treated with SOF/VEL 400/100 mg ± ribavirin for 12 weeks. The primary outcome was sustained virologic response 12 weeks after end of therapy (SVR12). Factors associated with not achieving SVR12 were evaluated using logistic regression and covariate analysis. Safety was also assessed.ResultsIn total, 3480 patients were included: 86.8% genotype 1/2, 2.8% genotype 3, 0.1% genotype 4/5, 9.6% genotype 6; unclassified, 0.8%; 12.2% compensated cirrhosis; 3.3% decompensated cirrhosis; and 15.8% chronic kidney disease. Overall SVR12 rate was 99.4% (genotype 1, 99.5%; genotype 2, 99.4%; genotype 3, 96.9%; genotype 4, 100%; genotype 6, 99.7%). SVR12 rates among patients with compensated cirrhosis, decompensated cirrhosis, and chronic kidney disease stages 4-5 were 99.5%, 100%, and 100%, respectively. There were 21 patients (0.6%) who did not achieve SVR12. Factors associated with failure were treatment adherence below 60%, high viral load, and genotype 3 (p < 0.001, p = 0.028, and p = 0.001, respectively). Adverse events occurred in 10% of patients; 0.6% were serious and one was related to treatment. Treatment discontinuation occurred in 0.3% of patients; none were treatment related. The estimated glomerular filtration rate remained stable throughout treatment and follow-up, regardless of baseline values and cirrhosis status.ConclusionSOF/VEL was highly effective and well tolerated in Taiwanese patients, irrespective of viral genotype, liver disease severity, and comorbidities.

Dataset Information

Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.

Publications

Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.

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