Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
POSITRON
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
1 other identifier
interventional
278
5 countries
63
Brief Summary
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
63 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
February 17, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 17, 2014
CompletedMay 19, 2014
May 1, 2014
8 months
February 17, 2012
January 6, 2014
May 8, 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
Post-treatment Week 12
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Baseline to Week 12
Secondary Outcomes (4)
Percentage of Participants Achieving SVR4
Post-treatment Week 4
Percentage of Participants Achieving SVR24
Post-treatment Week 24
Percentage of Participants Experiencing Viral Breakthrough
Baseline to Week 12
Percentage of Participants Experiencing Viral Relapse
End of treatment to post-treatment Week 24
Study Arms (2)
SOF+RBV
EXPERIMENTALParticipants were randomized to receive SOF+RBV for 12 weeks.
Placebo
PLACEBO COMPARATORParticipants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Infection with HCV genotype 2 or 3
- Cirrhosis determination
- Subject meets one of the following classifications:
- IFN unwilling
- IFN ineligible
- IFN intolerant
- Screening laboratory values within defined thresholds
- Subject has 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 interfere 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 (63)
University of Alabama Birmingham
Birmingham, Alabama, 35294-2170, United States
SCTI Research Foundation Liver Center
Coronado, California, 92118, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Lightspeed Medical
Los Angeles, California, 90036, United States
Anthony Mills MD, Inc.
Los Angeles, California, 90069, United States
Medical Associates Research Group
San Diego, California, 912123, United States
UCSD Antiviral Research Center
San Diego, California, 92103, 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
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
Jacksonville, Florida, 32256, United States
University of Miami, Center for Liver Diseases
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.
Saint Paul, Minnesota, 55407, 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
Binghamton Gastroenterology Associates
Binghamton, New York, 13903, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Duke University
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
Gastro One
Germantown, Tennessee, 38138, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219, United States
Therapeutic Concepts, PA
Houston, Texas, 77004, 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
Liver Institute of Virginia, Bon Secours St.Mary's
Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
St. Vincent's Hospital
Melbourne, 3065, Australia
Monash Medical Centre
Melbourne, 3168, Australia
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
CHUM - The Research Centre
Montreal, Quebec, H2X 3J4, Canada
Auckland Clinical Studies Limited
Auckland, 1640, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 00909-1711, Puerto Rico
Related Publications (2)
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.
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
February 17, 2012
First Posted
March 2, 2012
Study Start
March 1, 2012
Primary Completion
November 1, 2012
Study Completion
February 1, 2013
Last Updated
May 19, 2014
Results First Posted
February 17, 2014
Record last verified: 2014-05