Conditions: Hepatitis C
Keywords: Hepatitis Genotype 1 Genotype 3 Treatment experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks. arm 2: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 3: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. arm 4: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. arm 5: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. arm 6: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 7: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. arm 8: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. arm 9: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. arm 10: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 11: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. arm 12: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Interventions: intervention 1: SOF intervention 2: VEL intervention 3: RBV
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: Tablet administered orally once daily intervention 3: 200 mg 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: