Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir Velpatasvir SOF/VEL GS-5816 Hepatitis C HCV Cirrhosis CPT-B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 268
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Detailed description:

Arms:
arm 1: Participants will receive SOF/VEL FDC for 12 weeks. arm 2: Participants will receive SOF/VEL FDC plus RBV for 12 weeks. arm 3: Participants will receive SOF/VEL FDC for 24 weeks.

Interventions: intervention 1: SOF/VEL intervention 2: RBV
Intervention descriptions: intervention 1: 400/100 mg tablets administered orally once daily intervention 2: Ribavirin (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: