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

Phase 3

Completed

Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virologic Response (SVR)12	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug	Baseline to Week 12	The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral Breakthrough	Baseline to Week 12	Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Percentage of Participants With Viral Relapse	End of treatment to post-treatment Week 24	Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Percentage of Participants Achieving SVR4	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Percentage of Participants Achieving SVR24	Posttreatment Week 24	SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy

Locations (55): University of Alabama Birmingham
🇺🇸
Birmingham, Alabama, United States
SCTI Research Foundation
🇺🇸
Coronado, California, United States
Kaiser Permanente
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San Diego, California, United States
Peter J. Ruane, MD, Inc.
🇺🇸
Los Angeles, California, United States
Anthony Mills MD, Inc.
🇺🇸
Los Angeles, California, United States
University of California San Diego
🇺🇸
San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸
San Diego, California, United States
Quest Clinical Research
🇺🇸
San Francisco, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
South Denver Gastroenterology, PC
🇺🇸
Englewood, Colorado, United States
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University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States