Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Timeline

Start

2016-04-04

Primary completion

2017-06-26

Completion

2017-09-13

Publications

• Background Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.
• Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.

Drugs

Indications