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

• Status: Completed
• Trial end date: 2017-02-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

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.