Conditions: Hepatitis C Virus Infection
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 205
Healthy volunteers: no

Brief summary:
This 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) ± ribavirin (RBV) in adults with chronic 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: VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis) arm 3: VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) arm 4: VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) arm 5: VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis) arm 6: VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis) arm 7: VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis) arm 8: GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis) arm 9: GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis) arm 10: VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)

Interventions: intervention 1: VOX intervention 2: SOF/VEL intervention 3: RBV
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 intervention 3: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: