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
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01542788
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.
Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+RBV SOF Participants were randomized to receive SOF+RBV for 12 weeks. Placebo Placebo to match SOF Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebo Placebo to match RBV Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. SOF+RBV RBV Participants were randomized to receive SOF+RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving SVR12 Post-treatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks after cessation of therapy
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug Baseline to Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving SVR4 Post-treatment Week 4 SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Percentage of Participants Achieving SVR24 Post-treatment Week 24 SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy
Percentage of Participants Experiencing Viral Breakthrough Baseline to Week 12 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
Percentage of Participants Experiencing Viral Relapse End of treatment to post-treatment Week 24 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
Trial Locations
- Locations (62)
Anthony Mills MD, Inc.
🇺🇸Los Angeles, California, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
CHUM - The Research Centre
🇨🇦Montreal, Quebec, Canada
Auckland Clinical Studies Limited
🇳🇿Auckland, New Zealand
(G.I.R.I.) Gastrointestinal Research Institute
🇨🇦Vancouver, British Columbia, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Minnesota Gastroenterology, P.A.
🇺🇸St. Paul, Minnesota, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Lightspeed Medical
🇺🇸Los Angeles, California, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Westmead Hospital
🇦🇺Westmead,, New South Wales, Australia
Binghamton Gastroenterology Associates
🇺🇸Binghamton, New York, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Inova Fairfax Hospital Center for Liver Diseases
🇺🇸Falls Church, Virginia, United States
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Gastro One
🇺🇸Germantown, Tennessee, United States
Liver Institute of Virginia, Bon Secours St.Mary's
🇺🇸Newport News, Virginia, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
St. Vincent's Hospital
🇦🇺Melbourne, Australia
Monash Medical Centre
🇦🇺Melbourne, Australia
Gordon & Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
SCTI Research Foundation Liver Center
🇺🇸Coronado, California, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States
UCSD Antiviral Research Center
🇺🇸San Diego, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Miami, Center for Liver Diseases
🇺🇸Miami, Florida, United States
Orlando Immunology Center (ACH)
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Nashville Gastrointestinal Specialists, Inc
🇺🇸Nashville, Tennessee, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States