Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497366
First received: December 19, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Condition Intervention Phase
Hepatitis C
Drug: Sofosbuvir
Drug: PEG
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients 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 With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.


Secondary Outcome Measures:
  • Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days following the last dose of study drug ] [ Designated as safety issue: No ]
  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ] [ Designated as safety issue: No ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.

  • Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]

    Virologic failure was defined as either

    • Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement
    • Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement
    • Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)

  • Percentage of Participants With Viral Relapse Following Treatment [ Time Frame: Up to Post-treatment Week 24 ] [ Designated as safety issue: Yes ]
    Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.


Enrollment: 527
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg
Active Comparator: PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: Pegasys®
Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Genotype 2 or 3 HCV-infection
  • Naive to all HCV antiviral treatment(s)

Exclusion Criteria:

  • Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease
  • History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
  • Participation in a clinical study within 3 months prior to first dose
  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: NCT01497366

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Alabama Liver & Digestive Specialist
Montgomery, Alabama, United States, 36116
United States, California
Franco Felizarta, MD
Bakersfield, California, United States, 93301
California Liver Institute
Beverly Hills, California, United States, 90210
Arrowhead Regional Medical Center
Colton, California, United States, 92324
SCTI Research Foundation
Coronado, California, United States, 92118
eStudy Site
La Mesa, California, United States, 91940
Peter J. Ruane, M.D. Inc.
Los Angeles, California, United States, 90036
eStudySite
Oceanside, California, United States, 92056
University of California, Davis - Health System
Sacramento, California, United States, 95817
University of California San Diego Medical Center
San Diego, California, United States, 92103
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
Research and Education, Inc.
San Diego, California, United States, 92105
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Colorado
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
United States, Florida
Pointe West Infectious Diseases
Bradenton, Florida, United States, 34209
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States, 34982
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States, 32256
University of Miami, School of Medicine
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Advanced Research Institute
Trinity, Florida, United States, 34655
South Florida Center of Gastroenterology
Wellington, Florida, United States, 33414
United States, Georgia
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States, 30308
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
United States, Maryland
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
The Research Institute
Springfield, Massachusetts, United States, 01105
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Partners in Internal Medicine, PC
Worcester, Massachusetts, United States, 01608-1320
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Mississippi
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, New Jersey
Veterans Affairs Medical Center
East Orange, New Jersey, United States, 07018
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
ID Care
Hillsborough, New Jersey, United States, 08844
Atlantic Research Affiliates, LLC
Morristown, New Jersey, United States, 07960
United States, New Mexico
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States, 87505
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai School of Medicine
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14662
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
Carolinas Center for Liver Disease
Statesville, North Carolina, United States, 28677
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Schleinitz Research and Gastroenterology LLC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
UPMC Center For Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
University Gastroenterology
Warwick, Rhode Island, United States, 02886
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
Baylor University Medical Center
Dallas, Texas, United States, 75246
VAMC & Baylor College
Houston, Texas, United States, 77030
Kelsey-Seybold Clinic PA
Houston, Texas, United States, 77005
Research Specialists of Texas
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Digestive and Liver Disease Specialist, Ltd.
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2137
St. George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Gallipoli MRF
Greenslopes, Queensland, Australia, 4120
Royal Brisbane Hospital Research Foundation
Herston, Queensland, Australia, 4029
Princess Alexandria
Woollongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austin Hospital
Heidelberg, Victoria, Australia, 3084
The Alfred
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sir Charles Gairdner
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Canada, British Columbia
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network-Toronto Western Hospital
Toronto, Ontario, Canada, M5G 2N2
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Italy
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo, Italy, 71013
Netherlands
Academish Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand
Tauranga Hospital
Tauranga, BOP, New Zealand, 3143
Christchurch Hospital
Chrischurch, Canterbury, New Zealand, 8001
Mercy Hospital
Dunedin, OTA, New Zealand, 9010
Waikato Hospital (District Health Board)
Hamilton, Waikato, New Zealand, 3240
Wellington Hospital
Newtown, WGN, New Zealand, 6021
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Sweden
Sahlgrenska Universitetssjukhuset, Östra Sjukhus
Göteborg, Sweden, 41685
Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden, 171 76
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: NCT01497366     History of Changes
Other Study ID Numbers: P7977-1231
Study First Received: December 19, 2011
Results First Received: January 15, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
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 22, 2014