Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
- Registration Number
- NCT01329978
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
- Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
- Naive to previous HCV treatment
- Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History of any other clinically significant chronic liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+PEG+RBV 12 weeks Sofosbuvir Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. SOF+PEG+RBV 12 week/Rerandomization Group PEG Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks. SOF+PEG+RBV 24 weeks RBV Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. SOF+PEG+RBV 12 weeks PEG Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. SOF+PEG+RBV 24 weeks Sofosbuvir Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. SOF+PEG+RBV 12 weeks RBV Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. SOF+PEG+RBV 24 weeks PEG Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. SOF+PEG+RBV 12 week/Rerandomization Group Sofosbuvir Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks. SOF+PEG+RBV 12 week/Rerandomization Group RBV Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) Post-treatment Week 24 SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Percentage of Participants Who Experienced Adverse Events Baseline (Day 1) to post-treatment Day 30 Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) Post-treatment Week 12 SVR12 was defined as HCV RNA \< LOD 12 weeks after the last dose of study drug.
Change in HCV RNA at Week 2 Baseline (Day 1) to Week 2 Change in HCV RNA at Week 4 Baseline (Day 1) to Week 4 Change in HCV RNA at Week 8 Baseline (Day 1) to Week 8 Change in HCV RNA at Week 12 Baseline (Day 1) to Week 12 Percentage of Participants With HCV RNA < LOD at Week 2 Week 2 Percentage of Participants With HCV RNA Below < LOD at Week 4 Week 4 Percentage of Participants With HCV RNA Below < LOD at Week 8 Week 8 Percentage of Participants With HCV RNA Below < LOD at Week 12 Week 12 Percentage of Participants With HCV RNA Below < LOD at Week 24 Week 24 Percentage of Participants With ALT Normalization at Week 12 Baseline (Day 1) to Week 12 ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at Week 12.
Percentage of Participants With ALT Normalization at Week 24 Baseline (Day 1) to Week 24 ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
Percentage of Participants With ALT Normalization at Post-treatment Week 4 Baseline (Day 1) to Post-treatment Week 4 ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
Percentage of Participants With Virologic Failure During Treatment Baseline (Day 1) to Week 24 Virologic failure was defined as either
* HCV RNA ≥ 15 IU/mL after having previously had HCV RNA \< 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
* \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
* HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)
Baseline was Day 1 for all groups.Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). End of treatment to Post-treatment Week 24 Viral relapse was defined as HCV RNA \< 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.
Trial Locations
- Locations (46)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
St. Louis University Gastroenterology and Hepatology Clinical Research
🇺🇸St. Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Columbia Gastroenterology Associates
🇺🇸Columbia, South Carolina, United States
Baylor University
🇺🇸Dallas, Texas, United States
Southern California Liver Centers
🇺🇸Coronado, California, United States
Desta Digestive Disease Medical Center
🇺🇸San Diego, California, United States
Kaiser Permanente Hepatology Research
🇺🇸San Diego, California, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Colorado Denver Transplant Center and Hepatology Clinic
🇺🇸Aurora, Colorado, United States
Baylor/ St. Luke's Advanced Liver Therapy
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
eStudy Site
🇺🇸Oceanside, California, United States
Medical Associates Reseach Group
🇺🇸San Diego, California, United States
Advanced Research Institute
🇺🇸Trinity, Florida, United States
South Florida Center of Gastroenterology
🇺🇸Wellington, Florida, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
South Denver Gastreoenterology
🇺🇸Englewood, Colorado, United States
Pointe West Infectious Disease
🇺🇸Bradenton, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Central Texas Cinical Research
🇺🇸Austin, Texas, United States
Beth Israel Deconess Medical Center
🇺🇸Boston, Massachusetts, United States
Digestive and Liver Disease Specialist
🇺🇸Norfolk, Virginia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Clinical Associates Research
🇺🇸Reisterstown, Maryland, United States
Concorde Medical Group
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
North Texas Research Institute
🇺🇸Arlington, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
University Of Puerto Rico
🇵🇷San Juan, Puerto Rico
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Clopton Clinic
🇺🇸Jonesboro, Arkansas, United States
Alabama Liver and Digestive Specialist
🇺🇸Montgomery, Alabama, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Avail Clinical Research
🇺🇸Deland, Florida, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
U Mass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of New Mexico Health Science Center
🇺🇸Albuquerque, New Mexico, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States