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

Chronic Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604850
• Other study ID #: GS-US-334-0108
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2012
• Last updated: May 9, 2014
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  New Zealand,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants Achieving SVR4	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).	Posttreatment Week 4	No
Secondary	Percentage of Participants Achieving SVR24	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).	Posttreatment Week 24	No
Secondary	Percentage of Participants With Viral Breakthrough	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).	Up to 16 weeks	No
Secondary	Percentage of Participants With Viral Relapse	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).	End of treatment to posttreatment Week 24	No