Conditions: Hepatitis C Virus Infection
Keywords: Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:

Arms:
arm 1: SOF/VEL/VOX tablet for 8 weeks arm 2: SOF/VEL tablet for 12 weeks

Interventions: intervention 1: SOF/VEL/VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily without regard to food

Protocol document: