Phase 3 Study of Sofosbuvir and Ribavirin
- Registration Number
- NCT01497366
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 527
- Chronic Genotype 2 or 3 HCV-infection
- Naive to all HCV antiviral treatment(s)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sofosbuvir+RBV Sofosbuvir Participants were randomized to receive sofosbuvir+RBV for 12 weeks. PEG+RBV PEG Participants were randomized to receive PEG+RBV for 24 weeks. Sofosbuvir+RBV RBV Participants were randomized to receive sofosbuvir+RBV for 12 weeks. PEG+RBV RBV Participants were randomized to receive PEG+RBV for 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) Post-treatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities Up to 24 weeks plus 30 days following the last dose of study drug Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) Post-treatment Week 24 SVR24 was defined as HCV RNA \< LLOQ 24 weeks after study drug cessation.
Percentage of Participants With HCV RNA < LLOQ on Treatment Up to 12 Weeks Change From Baseline in HCV RNA Baseline to Week 12 Percentage of Participants With Virologic Failure During Treatment Baseline up to Week 24 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 Up to Post-treatment Week 24 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.
Trial Locations
- Locations (96)
Peter J. Ruane, M.D. Inc.
🇺🇸Los Angeles, California, United States
AIDS Research Consortium of Atlanta, Inc.
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Digestive Disease Associates, P.A.
🇺🇸Baltimore, Maryland, United States
UPMC Center For Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Sir Charles Gairdner
🇦🇺Nedlands, Western Australia, Australia
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Nashville Gastrointestinal Specialists Inc.
🇺🇸Nashville, Tennessee, United States
Kelsey-Seybold Clinic PA
🇺🇸Houston, Texas, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Research and Education, Inc.
🇺🇸San Diego, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
University of Miami, School of Medicine
🇺🇸Miami, Florida, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
South Florida Center of Gastroenterology
🇺🇸Wellington, Florida, United States
eStudySite
🇺🇸Oceanside, California, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Atlantic Research Affiliates, LLC
🇺🇸Morristown, New Jersey, United States
VAMC & Baylor College
🇺🇸Houston, Texas, United States
Gallipoli MRF
🇦🇺Greenslopes, Queensland, Australia
Princess Alexandria
🇦🇺Woollongabba, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
(G.I.R.I.) Gastrointestinal Research Institute
🇨🇦Vancouver, British Columbia, Canada
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
eStudy Site
🇺🇸La Mesa, California, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
SCTI Research Foundation
🇺🇸Coronado, California, United States
Midway Immunology & Research Center, LLC
🇺🇸Fort Pierce, Florida, United States
Borland-Groover Clinic Baptist
🇺🇸Jacksonville, Florida, United States
Advanced Research Institute
🇺🇸Trinity, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Partners in Internal Medicine, PC
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center
🇺🇸East Orange, New Jersey, United States
Southwest C.A.R.E. Center
🇺🇸Santa Fe, New Mexico, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Schleinitz Research and Gastroenterology LLC
🇺🇸Medford, Oregon, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Digestive and Liver Disease Specialist, Ltd.
🇺🇸Norfolk, Virginia, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Royal Brisbane Hospital Research Foundation
🇦🇺Herston, Queensland, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
The Alfred
🇦🇺Melbourne, Victoria, Australia
University Health Network-Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
🇨🇦Vaughan, Ontario, Canada
Casa Sollievo della Sofferenza Hospital
🇮🇹San Giovanni Rotondo, Italy
Academish Medisch Centrum
🇳🇱Amsterdam, Netherlands
Waikato Hospital (District Health Board)
🇳🇿Hamilton, Waikato, New Zealand
Mercy Hospital
🇳🇿Dunedin, OTA, New Zealand
Auckland City Hospital
🇳🇿Grafton, Auckland, New Zealand
Tauranga Hospital
🇳🇿Tauranga, BOP, New Zealand
Christchurch Hospital
🇳🇿Chrischurch, Canterbury, New Zealand
Wellington Hospital
🇳🇿Newtown, WGN, New Zealand
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Karolinska Universitetssjukhuset, Solna
🇸🇪Stockholm, Sweden
Sahlgrenska Universitetssjukhuset, Östra Sjukhus
🇸🇪Göteborg, Sweden
University of Massachusetts, Worcester
🇺🇸Worcester, Massachusetts, United States
Alabama Liver & Digestive Specialist
🇺🇸Montgomery, Alabama, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
California Liver Institute
🇺🇸Beverly Hills, California, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Pointe West Infectious Diseases
🇺🇸Bradenton, Florida, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Carolinas Center for Liver Disease
🇺🇸Statesville, North Carolina, United States
Gastroenterology United of Tulsa
🇺🇸Tulsa, Oklahoma, United States
University Gastroenterology
🇺🇸Warwick, Rhode Island, United States
University of California, Davis - Health System
🇺🇸Sacramento, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States