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

Gilead Sciences60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus

Interventions

SOFDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBVDRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants discontinuing any study drug due to an adverse event was summarized.

Time frame: Up to 24 weeks

Secondary Outcomes

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

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

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants Experiencing On-treatment Virologic Failure

On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

Time frame: Up to 24 weeks

Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.

Data from ClinicalTrials.gov

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