Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
- Registration Number
- NCT02378961
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two contraception methods if female of childbearing potential or sexually active male
Key
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description VOX+SOF/VEL 8 wk,TE, without cirrhosis VOX GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) VOX+SOF/VEL 8 wk,TE, without cirrhosis SOF/VEL GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) VOX+SOF/VEL 12 wk, TE, without cirrhosis VOX VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) GS-9857+SOF/VEL 8 wk, TE, with cirrhosis SOF/VEL GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) VOX+SOF/VEL 6 wk, TN, without cirrhosis VOX VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) VOX+SOF/VEL 6 wk, TN, without cirrhosis SOF/VEL VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) GS-9857+SOF/VEL 6 wk, TN, with cirrhosis VOX GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) GS-9857+SOF/VEL 6 wk, TN, with cirrhosis SOF/VEL GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) VOX+SOF/VEL 8 wk, TN, with cirrhosis VOX GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) VOX+SOF/VEL 8 wk, TN, with cirrhosis SOF/VEL GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) VOX+SOF/VEL 12 wk, TE, without cirrhosis SOF/VEL VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) GS-9857+SOF/VEL 8 wk, TE, with cirrhosis VOX GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) VOX+SOF/VEL 12 wk, TE, with cirrhosis VOX VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) VOX+SOF/VEL 12 wk, TE, with cirrhosis SOF/VEL VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 12 Weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ on Treatment Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) HCV RNA Change From Baseline Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 * 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 (34)
Stanford University
🇺🇸Palo Alto, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Huntington Memorial Hospital Liver Center
🇺🇸Pasadena, California, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
UPMC Center for Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Auckland Clinical Studies
🇳🇿Grafton, New Zealand
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital and Health System
🇺🇸Detroit, Michigan, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
University of Miami
🇺🇸Miami, Florida, United States
Orlando Immunology center
🇺🇸Orlando, Florida, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Center for Hep C/Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
Beth Isreal Deconess Medical Center
🇺🇸Boston, Massachusetts, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸Wellington, Florida, United States
Indianapolis Gastroenterology & Hepatology, Inc.
🇺🇸Indianapolis, Indiana, United States
Southwest Care Center
🇺🇸Santa Fe, New Mexico, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
North Shore/Long Island Jewish PRIME
🇺🇸Manhasset, New York, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
University of Pennsylvania Health Systems
🇺🇸Philadelphia, Pennsylvania, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Nashville Gastrointestinal Specialists Inc.
🇺🇸Nashville, Tennessee, United States
Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
Christchurch Clinical Studies Trust
🇳🇿Christchurch, New Zealand
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Swedish Medical
🇺🇸Seattle, Washington, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States