Conditions: Hepatitis C Virus Infection
Keywords: Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 333
Healthy volunteers: no

Brief summary:
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Detailed description:

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