Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection
1 other identifier
interventional
128
3 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2015
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2016
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedMarch 3, 2020
October 1, 2017
7 months
February 27, 2015
August 16, 2017
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 Weeks
Secondary Outcomes (4)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
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
Study Arms (7)
VOX+SOF/VEL 6 wk, TN, without cirrhosis
EXPERIMENTALVOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
GS-9857+SOF/VEL 6 wk, TN, with cirrhosis
EXPERIMENTALGS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, TN, with cirrhosis
EXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk,TE, without cirrhosis
EXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
VOX+SOF/VEL 12 wk, TE, without cirrhosis
EXPERIMENTALVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
GS-9857+SOF/VEL 8 wk, TE, with cirrhosis
EXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
VOX+SOF/VEL 12 wk, TE, with cirrhosis
EXPERIMENTALVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
Interventions
100 mg tablet(s) administered orally once daily with food
400/100 mg FDC tablet administered orally once daily with food
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (34)
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
Aurora, 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 School of Medicine
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
Seattle, Washington, United States
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Auckland Clinical Studies
Grafton, New Zealand
Fundacion de Investigacion de Diego
San Juan, Puerto Rico
Related Publications (1)
Gane EJ, Kowdley KV, Pound D, Stedman CA, Davis M, Etzkorn K, Gordon SC, Bernstein D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Tong M, Chung RT, Beavers K, Poulos JE, Kwo PY, Nguyen MH. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):902-909. doi: 10.1053/j.gastro.2016.07.038. Epub 2016 Jul 30.
PMID: 27486033RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 4, 2015
Study Start
February 16, 2015
Primary Completion
September 21, 2015
Study Completion
January 26, 2016
Last Updated
March 3, 2020
Results First Posted
September 15, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.