Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic 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 genotype 1
- 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
- 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 Center
- Auckland Clinical Studies
- Christchurch Clinical Studies Trust
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)