Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Inclusion Criteria:

• First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
• Treatment-experienced or treatment-naive
• Chronic genotype 4 HCV infection
• Not co-infected with HIV
• Screening laboratory values within defined thresholds
• Use of highly effective contraception methods
• 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 treatment, assessment, or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse