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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01604850
First received: May 21, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis C
Drug: SOF
Drug: RBV
Drug: Placebo to match SOF
Drug: Placebo to match RBV
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants Achieving SVR12 [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.


Secondary Outcome Measures:
  • Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ] [ Designated as safety issue: No ]

    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 Achieving SVR24 [ Time Frame: Posttreatment Week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

    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 With Viral Relapse [ Time Frame: End of treatment to posttreatment Week 24 ] [ Designated as safety issue: No ]

    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).



Enrollment: 202
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: 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).
Drug: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Drug: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Experimental: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604850

  Hide Study Locations
Locations
United States, California
SCTI Research Foundation
Coronado, California, United States, 92118
Anthony Mills MD, Inc.
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente
Los Angeles, California, United States, 90027
Kaiser Permanente
San Diego, California, United States, 92154
UCSD Antiviral Research Center
San Diego, California, United States, 92103
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0277
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States, 32256
University of Miami
Miami, Florida, United States, 33136
Advanced Research Institute
New Port Richey, Florida, United States, 34653
Orlando Immunology Center (ACH)
Orlando, Florida, United States, 32803-1851
Internal Medicine Specialists
Orlando, Florida, United States, 32806
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, United States, 33414
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Michigan
Henry Ford Health System
Novi, Michigan, United States, 48377
United States, Minnesota
Minnesota Gastroenterology, P.A.
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
ID Care
Hillsborough, New Jersey, United States, 08844
United States, New Mexico
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Binghamton Gastroenterology Associates
Binghamton, New York, United States, 13903
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75219
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, United States, 22042
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States, 23226
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 2C9
Canada, Manitoba
University of Manitoba Health Sciences Center
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Hopital St. Luc
Montreal, Quebec, Canada, H2X 3J4
New Zealand
Auckland Clinical Studies Limited
Auckland, New Zealand, 1640
Christchurch Hospital
Christchurch, New Zealand, 8011
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 00909-1711
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01604850     History of Changes
Other Study ID Numbers: GS-US-334-0108
Study First Received: May 21, 2012
Results First Received: March 31, 2014
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Treatment Experienced
GS-7977
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014