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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01713283

GS-US-334-0114

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

SOF+RBV 12 Weeks

Experimental group

Description:

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

SOF+RBV 24 Weeks

Experimental group

Description:

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.

Treatment:

Drug: RBV

Drug: SOF