Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
- Registration Number
- NCT01641640
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
-
Infection with HCV genotype 1, 4, 5, or 6
-
Cirrhosis determination
-
Subject met the following classifications:
- Treatment-naive
- Screening laboratory values within defined thresholds
- Not treated with any investigational drug or device within 30 days of screening
-
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 have interfered with subject treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sofosbuvir+PEG+RBV RBV - Sofosbuvir+PEG+RBV PEG - Sofosbuvir+PEG+RBV Sofosbuvir -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virologic Response (SVR)12 Posttreatment 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 participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With 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 With 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.
Percentage of Participants Achieving SVR4 Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Percentage of Participants Achieving SVR24 Posttreatment Week 24 SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (55)
Peter J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States
Borland-Groover Clinic Baptist
🇺🇸Jacksonville, Florida, United States
Infectious Disease Specialist of Atlanta
🇺🇸Decatur, Georgia, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Minnesota Gastroenterology, P.A.
🇺🇸St. Paul, Minnesota, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
University of Miami Center for Liver Diseases
🇺🇸Miami, Florida, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville Gastrointestinal Specialists, Inc
🇺🇸Nashville, Tennessee, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Capital Medical Associates
🇺🇸Washington, District of Columbia, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Southwest C.A.R.E. Center
🇺🇸Santa Fe, New Mexico, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Binghamton Gastroenterology Associates
🇺🇸Binghamton, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Inova Fairfax Hospital Center for Liver Diseases
🇺🇸Falls Church, Virginia, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
SCTI Research Foundation
🇺🇸Coronado, California, United States
Anthony Mills MD, Inc.
🇺🇸Los Angeles, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Orlando Immunology Center (ACH)
🇺🇸Orlando, Florida, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States