Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

Detailed description:

Arms:
arm 1: SOF/VEL/VOX for 12 weeks arm 2: Placebo to match SOF/VEL/VOX for 12 weeks arm 3: SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo

Interventions: intervention 1: SOF/VEL/VOX intervention 2: Placebo
Intervention descriptions: intervention 1: 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food intervention 2: Tablet administered orally once daily with food

Protocol document: