Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.

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.

Inclusion Criteria:

• Treatment experienced and naïve subjects
• Chronic genotype 4 HCV-infection
• Not co-infected with HIV
• Screening laboratory values within defined thresholds
• Use of highly effective contraception methods
• Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria:

• History of any other clinically significant chronic liver disease
• Pregnant or nursing female or male with pregnant female partner
• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse