Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
FUSION
A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
1 other identifier
interventional
202
4 countries
67
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
Shorter than P25 for phase_3
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
May 1, 2014
CompletedMay 28, 2014
May 1, 2014
8 months
May 21, 2012
March 31, 2014
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving SVR12
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).
Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Baseline to Week 16
Secondary Outcomes (4)
Percentage of Participants Achieving SVR4
Posttreatment Week 4
Percentage of Participants Achieving SVR24
Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Up to 16 weeks
Percentage of Participants With Viral Relapse
End of treatment to posttreatment Week 24
Study Arms (2)
SOF+RBV+placebo
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants were randomized to receive SOF+RBV for 16 weeks.
Interventions
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (67)
SCTI Research Foundation
Coronado, California, 92118, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Anthony Mills MD, Inc.
Los Angeles, California, 90069, United States
UCSD Antiviral Research Center
San Diego, California, 92103, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
University of Florida
Gainesville, Florida, 32610-0277, United States
Borland-Groover Clinic Baptist
Jacksonville, Florida, 32256, United States
University of Miami
Miami, Florida, 33136, United States
Advanced Research Institute
New Port Richey, Florida, 34653, United States
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, 33414, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
Minnesota Gastroenterology, P.A.
Minneapolis, Minnesota, 55414, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505, United States
Binghamton Gastroenterology Associates
Binghamton, New York, 13903, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Gastro One
Germantown, Tennessee, 38138, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, 23226, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
University of British Columbia
Vancouver, British Columbia, V6Z 2C9, Canada
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
University of Manitoba Health Sciences Center
Winnipeg, Manitoba, R3E 3P4, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Hopital St. Luc
Montreal, Quebec, H2X 3J4, Canada
Auckland Clinical Studies Limited
Auckland, 1640, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Clinical Research Puerto Rico Inc
San Juan, PR, 00909-1711, Puerto Rico
Fundacion De Investigacion De Diego
San Juan, PR, 00927, Puerto Rico
Related Publications (3)
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.
PMID: 25583164DERIVEDStepanova 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.
PMID: 25040192DERIVEDJacobson 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.
PMID: 23607593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 24, 2012
Study Start
June 1, 2012
Primary Completion
February 1, 2013
Study Completion
May 1, 2013
Last Updated
May 28, 2014
Results First Posted
May 1, 2014
Record last verified: 2014-05