Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C HCV cirrhosis Sofosbuvir Sovaldi SOF/VEL GS-5816 GS-7977 liver Treatment naive Treatment Experience genotype 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 269
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: SOF/VEL FDC for 12 weeks arm 2: SOF+RBV for 12 weeks

Interventions: intervention 1: SOF/VEL intervention 2: SOF intervention 3: RBV
Intervention descriptions: intervention 1: SOF/VEL (400/100 mg) FDC tablet administered orally once daily intervention 2: SOF 400 mg tablet administered orally once daily intervention 3: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: