Clinical trial NCT01604850: Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Treatment Experienced
GS-7977
Ribavirin
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving SVR12
timeFrame: Posttreatment Week 12
measure: Adverse Events Leading to Permanent Discontinuation of Study Drug
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving SVR4
timeFrame: Posttreatment Week 4
measure: Percentage of Participants Achieving SVR24
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Up to 16 weeks
measure: Percentage of Participants With Viral Relapse
timeFrame: End of treatment to posttreatment Week 24
Other outcomes:
Locations:
city: Coronado
country: United States
facility: SCTI Research Foundation
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD, Inc.
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Washington
country: United States
facility: Whitman Walker Clinic
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic Baptist
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center (ACH)
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, P.A.
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest C.A.R.E. Center
state: New Mexico
city: Binghamton
country: United States
facility: Binghamton Gastroenterology Associates
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists, Inc
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: Southwest Infectious Disease Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital Center for Liver Diseases
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc.
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: (G.I.R.I.) Gastrointestinal Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Center
state: Manitoba
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital St. Luc
state: Quebec
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Limited
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.