Conditions: Hepatitis C Virus Infection
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 128
Healthy volunteers: no

Brief summary:
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) arm 2: GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) arm 3: GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) arm 4: GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) arm 5: VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) arm 6: GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) arm 7: VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)

Interventions: intervention 1: VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 100 mg tablet(s) administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily with food

Protocol document: