Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

Gilead Sciences103 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Hepatitis C Virus

Interventions

SOFDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBVDRUG

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment experienced and naïve subjects * Chronic genotype 4 HCV-infection * Not co-infected with HIV * Screening laboratory values within defined thresholds * Use of highly effective contraception methods * Subject 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 subject treatment, assessment or compliance with the protocol * Excessive alcohol ingestion or significant drug abuse

Locations (2)

Unnamed facility

Al Mansurah, Egypt

Unnamed facility

Cairo, Egypt

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

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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 SVR 24 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 * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

Time frame: Up to 24 weeks

Percentage of Participants Experiencing Virologic Relapse

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Time frame: Up to Posttreatment Week 24

Data from ClinicalTrials.gov

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