Conditions: Hepatitis C Virus Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Detailed description:

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

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

Protocol document: