Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: Placebo to match sofosbuvirDrug: Placebo to match GS-0938
- Registration Number
- NCT01435044
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
- Chronic HCV-infection
- Naive to all HCV antiviral treatment
- Otherwise healthy patients
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History of any other clinically significant chronic liver disease
- Medical history which the investigator considers the patient unsuitable for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+RBV 12 Weeks Sofosbuvir Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks. SOF+RBV 12 Weeks RBV Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks. GS-0938 Alone GS-0938 Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks. GS-0938 Alone Placebo to match sofosbuvir Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks. GS-0938+SOF GS-0938 Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks. GS-0938+SOF+RBV Sofosbuvir Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks. GS-0938+SOF Sofosbuvir Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks. GS-0938+SOF+RBV RBV Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks. Placebo Placebo to match sofosbuvir Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks. Placebo Placebo to match GS-0938 Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks. GS-0938+SOF+RBV GS-0938 Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks. SOF+RBV 24 Weeks Sofosbuvir Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks. SOF+RBV 24 Weeks RBV Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks. Retreatment Group - SOF+RBV 24 Weeks Sofosbuvir After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks. Retreatment Group - SOF+RBV 24 Weeks RBV After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12) Post-treatment Week 12 SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Adverse Events Baseline to Week 24 plus 30 days Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.
Change from baseline in HCV RNA Baseline to Week 12 Percentage of Participants Who Developed Resistance to Sofosbuvir Baseline to Week 24 Percentage of Participants With ALT Normalization Baseline to post-treatment Week 4 ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at a subsequent visit.
Percentage of Participants With HCV RNA < LLOQ during treatment Baseline to Week 12 Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24) Post-treatment Weeks 4 and 24 SVR4 and SVR24 was defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.
Trial Locations
- Locations (32)
Advanced Research Institute
🇺🇸Trinity, Florida, United States
UCSD Antiviral Research Center
🇺🇸San Diego, California, United States
eStudy Site
🇺🇸San Diego, California, United States
Avail Clinical Research
🇺🇸Deland, Florida, United States
Ashville Gastroenterology Associates
🇺🇸Ashville, North Carolina, United States
Concorde Medical Group
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
CLI
🇺🇸Los Angeles, California, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
Alabama Liver & Digestive Specialists
🇺🇸Montgomery, Alabama, United States
Carolina's Center for Liver Disease
🇺🇸Statesville, North Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
University of Miami Center for Liver Diseases
🇺🇸Miami, Florida, United States
South Florida Center of Gastroenterology
🇺🇸Wellington, Florida, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Nashville Gastrointestinal Specialists
🇺🇸Nashville, Tennessee, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
University of Florida Hepatology
🇺🇸Gainesville, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Digestive Health Services
🇺🇸Downers Grove, Illinois, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States