Conditions: Chronic Hepatitis C
Keywords: HCV genotype 1 (GT-1) HCV genotype 4 (GT-4) HCV genotype 5 (GT-5) HCV genotype 6 (GT-6) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Treatment-Naïve GS-7977 Ribavirin RBV Peginterferon Alfa 2a PEG
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 328
Healthy volunteers: no

Brief summary:
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Protocol document: