Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

Phase 3

Completed

Interventions: Drug: SOF
Drug: Placebo to match SOF
Drug: Placebo to match RBV
Drug: RBV

Brief Summary: This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Detailed Description: Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Recruitment & Eligibility

Inclusion Criteria

Infection with HCV genotype 2 or 3
Cirrhosis determination
Subject meets one of the following classifications:
1. IFN unwilling
2. IFN ineligible
3. IFN intolerant
Screening laboratory values within defined thresholds
Subject 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 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 interfere with subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Arm && Interventions

Group	Intervention	Description
SOF+RBV	SOF	Participants were randomized to receive SOF+RBV for 12 weeks.
Placebo	Placebo to match SOF	Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Placebo	Placebo to match RBV	Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
SOF+RBV	RBV	Participants were randomized to receive SOF+RBV for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SVR12	Post-treatment 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 subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SVR4	Post-treatment Week 4	SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Percentage of Participants Achieving SVR24	Post-treatment Week 24	SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy
Percentage of Participants Experiencing 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 Experiencing 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

Locations (62): University of Alabama Birmingham
🇺🇸
Birmingham, Alabama, United States
SCTI Research Foundation Liver Center
🇺🇸
Coronado, California, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
Lightspeed Medical
🇺🇸
Los Angeles, California, United States
Anthony Mills MD, Inc.
🇺🇸
Los Angeles, California, United States
Medical Associates Research Group
🇺🇸
San Diego, California, United States
UCSD Antiviral Research Center
🇺🇸
San Diego, California, United States
Quest Clinical Research
🇺🇸
San Francisco, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
South Denver Gastroenterology
🇺🇸
Englewood, Colorado, United States
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University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States