Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Key Inclusion Criteria:

• Willing and able to provide written informed consent
• Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
• HCV genotype 4 at screening
• HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
• Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
• Body mass index (BMI) ≥ 18 kg/m^2
• Screening laboratory values within defined thresholds
• Use of effective protocol-approved contraception methods

Key Exclusion Criteria:

• History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Pregnant or nursing females or male with pregnant female partner
• Clinically-relevant drug or alcohol abuse within 12 months of screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.