Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Infection with HCV genotype 1, 4, 5, or 6

• Cirrhosis determination

• Subject met the following classifications:

• Treatment-naive

• Screening laboratory values within defined thresholds

• Not treated with any investigational drug or device within 30 days of screening

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 have interfered with subject treatment, assessment, or compliance with the protocol

• Excessive alcohol ingestion or significant drug abuse