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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

Criteria

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