Clinical trial NCT01826981
Conditions: Chronic Hepatitis C
Sponsor: Gilead Sciences
Start date: 2013-04-01; Completion date: 2015-05-01
Enrollment: 359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study arm 2: SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study arm 3: LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis arm 4: LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis arm 5: LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection arm 6: LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection arm 7: LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection arm 8: LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection arm 9: LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis arm 10: SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection arm 11: SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection arm 12: SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection arm 13: SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection arm 14: LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study arm 15: LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Interventions: intervention 1: LDV/SOF intervention 2: SOF intervention 3: RBV intervention 4: Peg-IFN intervention 5: GS-9669 intervention 6: VEL
Intervention descriptions: intervention 1: Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily intervention 2: SOF 400 mg tablet administered orally once daily intervention 3: Ribavirin (RBV) 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) intervention 4: pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly intervention 5: GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily intervention 6: Velpatasvir (VEL) tablet(s) administered orally once daily

Protocol documents: