Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: RBV; Drug: PEG; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808248

GS-US-334-0151

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infection with genotype 2 or 3 HCV infection
• Cirrhosis determination
• Individual is treatment-experienced
• Screening laboratory values within defined thresholds
• Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

• Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
• Excessive alcohol ingestion or significant drug abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

SOF+PEG+RBV

Experimental group

Description:

Participants will receive SOF+PEG+RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: PEG