Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Treatment-Naïve GS-7977 Ribavirin RBV Peginterferon Alfa 2a PEG Additional relevant MeSH terms: Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 47
Healthy volunteers: no

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

Detailed description:

Arms:
arm 1: Participants will receive SOF+PEG+RBV for 12 weeks.

Interventions: intervention 1: SOF intervention 2: PEG intervention 3: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection intervention 3: 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)

Protocol document: