Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
- Conditions
- Chronic Hepatitis C
- Interventions
- 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
- 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
- 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).
Related Research Topics
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Trial Locations
- Locations (65)
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Bon Secours St. Mary's Hospital of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
SCTI Research Foundation
🇺🇸Coronado, California, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
University of Manitoba Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Auckland Clinical Studies Limited
🇳🇿Auckland, New Zealand
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Inova Fairfax Hospital Center for Liver Diseases
🇺🇸Falls Church, Virginia, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
Hopital St. Luc
🇨🇦Montreal, Quebec, Canada
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
University of Florida
🇺🇸Gainesville, Florida, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Borland-Groover Clinic Baptist
🇺🇸Jacksonville, Florida, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Southwest C.A.R.E. Center
🇺🇸Santa Fe, New Mexico, United States
Binghamton Gastroenterology Associates
🇺🇸Binghamton, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Christchurch Hospital
🇳🇿Christchurch, New Zealand
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Gordon & Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
(G.I.R.I.) Gastrointestinal Research Institute
🇨🇦Vancouver, British Columbia, Canada
Kaiser Permanente
🇺🇸San Diego, California, United States
Peter J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Minnesota Gastroenterology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, 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
University of Miami
🇺🇸Miami, Florida, United States
Orlando Immunology Center (ACH)
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
Nashville Gastrointestinal Specialists, Inc
🇺🇸Nashville, Tennessee, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States