Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir Velpatasvir SOF/VEL GS-5816 Hepatitis C HCV Cirrhosis Genotype 3
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 558
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: SOF/VEL FDC for 12 weeks arm 2: SOF+RBV for 24 weeks

Interventions: intervention 1: SOF/VEL intervention 2: SOF intervention 3: RBV
Intervention descriptions: intervention 1: 400/100 mg FDC tablet administered orally once daily intervention 2: 400 mg tablet administered orally once daily intervention 3: 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: