Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
NCT ID: NCT02378935
Last Updated: 2020-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
205 participants
INTERVENTIONAL
2015-02-17
2016-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Interventions
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VOX
100 mg tablet(s) administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center
Pasadena, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
University of Colorado
Denver, Colorado, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Orlando Immunology center
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, United States
Center for Hep C/Atlanta Medical Center
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Indianapolis Gastroenterology & Hepatology, Inc.
Indianapolis, Indiana, United States
Beth Isreal Deconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital and Health System
Detroit, Michigan, United States
ID Care
Hillsborough, New Jersey, United States
Southwest Care Center
Santa Fe, New Mexico, United States
North Shore/Long Island Jewish PRIME
Manhasset, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc.
Nashville, Tennessee, United States
Texas Liver Institute
San Antonio, Texas, United States
Liver Institute of Virginia
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Auckland Clinical Studies
Auckland, , New Zealand
Christchurch Clinical Studies Trust
Christchurch, , New Zealand
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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References
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Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):893-901.e1. doi: 10.1053/j.gastro.2016.07.039. Epub 2016 Jul 30.
Other Identifiers
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GS-US-367-1168
Identifier Type: -
Identifier Source: org_study_id
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