Conditions: Hepatitis C Virus
Keywords: Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action HCV genotype 4 (GT-4) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 103
Healthy volunteers: no

Brief summary:
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: Participants will receive SOF+RBV for 12 weeks. arm 2: Participants will receive SOF+RBV for 24 weeks.

Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: