Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

Phase 3

Completed

Conditions: Chronic Hepatitis C

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

Registration Number: NCT01604850

Lead Sponsor: Gilead Sciences

Brief Summary: This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 202

Inclusion Criteria

Infection with HCV genotype 2 or 3
Had cirrhosis determination
Prior treatment failure
Screening laboratory values within defined thresholds
Subject had 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 have interfered with subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOF+RBV+placebo	SOF	Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
SOF+RBV+placebo	Placebo to match SOF	Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
SOF+RBV+placebo	Placebo to match RBV	Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
SOF+RBV	SOF	Participants were randomized to receive SOF+RBV for 16 weeks.
SOF+RBV	RBV	Participants were randomized to receive SOF+RBV for 16 weeks.
SOF+RBV+placebo	RBV	Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SVR12	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. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Adverse Events Leading to Permanent Discontinuation of Study Drug	Baseline to Week 16	Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SVR24	Posttreatment Week 24	SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Percentage of Participants With Viral Breakthrough	Up to 16 weeks	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. For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Percentage of Participants Achieving SVR4	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Percentage of Participants With Viral Relapse	End of treatment to posttreatment 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. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).

Trial Locations

Locations (65): SCTI Research Foundation
🇺🇸
Coronado, California, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
Peter J. Ruane, MD, Inc.
🇺🇸
Los Angeles, California, United States
Anthony Mills MD, Inc.
🇺🇸
Los Angeles, California, United States
UCSD Antiviral Research Center
🇺🇸
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
Whitman Walker Clinic
🇺🇸
Washington, District of Columbia, United States
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SCTI Research Foundation
🇺🇸Coronado, California, United States