Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
- Registration Number
- NCT01858766
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- Chronic HCV infection
- Body mass index (BMI) ≥ 18 kg/m^2
- HCV RNA ≥ 10000 IU/mL at screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Must not have cirrhosis
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Prior treatment of HCV with interferon or ribavirin
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+VEL 25 mg 12 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) SOF Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) VEL Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) SOF Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT3) SOF Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT3) VEL Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) VEL Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT3) SOF Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT3) VEL Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) RBV Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) RBV Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 12 weeks Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 Virologic failure was defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
* Virologic relapse:
* Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Trial Locations
- Locations (51)
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
University of Florida Center for Clinical Trials Research
🇺🇸Gainesville, Florida, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
South Florida Center of Gastroenterology, P.A
🇺🇸Wellington, Florida, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
INOVA Institute of Research & Education
🇺🇸Falls Church, Virginia, United States
Huntington Medical Research Institutes Liver Center
🇺🇸Pasadena, California, United States
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States
UCSD
🇺🇸La Jolla, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Southwest C.A.R.E. Center
🇺🇸Santa Fe, New Mexico, United States
Weill Cornell Medical College-New York Presbyterian Hospital
🇺🇸New York, New York, United States
North Shore/Long Island Jewish PRIME
🇺🇸Lake Success, New York, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
The Liver Institute of Virginia
🇺🇸Newport News, Virginia, United States
Digestive and Liver Disease Specialists, Ltd.
🇺🇸Norfolk, Virginia, United States
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ruane Peter J MD Incorporated
🇺🇸Los Angeles, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Kaiser Permanente Medical Grp
🇺🇸San Diego, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
🇺🇸Indianapolis, Indiana, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Kaiser Permante
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Transplant Physicians
🇺🇸Dallas, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Ctr
🇺🇸Baltimore, Maryland, United States
Nashville Gastrointestinal Specialists Inc.
🇺🇸Nashville, Tennessee, United States
Alamo Medical Research, LTD d/b/a American Research Corporation
🇺🇸San Antonio, Texas, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Center For Hepatitis C/Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
UPMC Center For Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States