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

Gilead Sciences255 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

255

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOFDRUG

90/400 mg FDC tablet administered orally once daily

RBVDRUG

Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Unnamed facility

Al Mansurah, Egypt

Unnamed facility

Cairo, Egypt

Unnamed facility

Cairo, Egypt

Unnamed facility

Shibīn al Kawm, Egypt

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

Time frame: 12 weeks

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of study drug, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants With Overall Virologic Failure

Virologic failure was defined as * On-treatment virologic failure * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough), * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), * HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Time frame: Up to Posttreatment Week 24

Data from ClinicalTrials.gov

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