Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
NCT ID: NCT01604850
Last Updated: 2014-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2012-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SOF+RBV+placebo
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
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Interventions
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SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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SCTI Research Foundation
Coronado, California, United States
Kaiser Permanente
Los Angeles, 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
Kaiser Permanente
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 D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Advanced Research Institute
New Port Richey, Florida, United States
Orlando Immunology Center (ACH)
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Johns Hopkins University
Lutherville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
Minnesota Gastroenterology, P.A.
Minneapolis, Minnesota, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
ID Care
Hillsborough, 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
Duke University Medical Center
Durham, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
University of Manitoba Health Sciences Center
Winnipeg, Manitoba, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Hopital St. Luc
Montreal, Quebec, Canada
Auckland Clinical Studies Limited
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Clinical Research Puerto Rico Inc
San Juan, PR, Puerto Rico
Fundacion De Investigacion De Diego
San Juan, PR, Puerto Rico
Countries
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References
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Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR; POSITRON Study; FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.
Other Identifiers
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GS-US-334-0108
Identifier Type: -
Identifier Source: org_study_id
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