Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Sites / Locations
- Cedars Sinai Medical Center
- Stanford University
- Huntington Memorial Hospital Liver Center
- Medical Associates Research Group, Inc.
- University of Colorado
- Borland-Groover Clinic
- University of Miami
- Orlando Immunology center
- South Florida Center of Gastroenterology, P.A.
- Center for Hep C/Atlanta Medical Center
- Gastrointestinal Specialists of Georgia, PC
- University of Chicago
- Indiana University School of Medicine
- Indianapolis Gastroenterology & Hepatology, Inc.
- Beth Isreal Deconess Medical Center
- Massachusetts General Hospital
- Henry Ford Hospital and Health System
- ID Care
- Southwest Care Center
- North Shore/Long Island Jewish PRIME
- Mount Sinai Beth Israel
- Cumberland Research Associates, LLC
- Digestive Health Specialists, PA
- University of Pennsylvania Health Systems
- UPMC Center for Liver Diseases
- Medical University of South Carolina
- Gastro One
- Nashville Gastrointestinal Specialists Inc.
- Texas Liver Institute
- Liver Institute of Virginia
- Swedish Medical
- Christchurch Clinical Studies Trust
- Auckland Clinical Studies
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
VOX+SOF/VEL 6 wk, TN, without cirrhosis
GS-9857+SOF/VEL 6 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk,TE, without cirrhosis
VOX+SOF/VEL 12 wk, TE, without cirrhosis
GS-9857+SOF/VEL 8 wk, TE, with cirrhosis
VOX+SOF/VEL 12 wk, TE, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)