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Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VOX
SOF/VEL
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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)

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
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
HCV RNA Change From Baseline
Percentage of Participants With Virologic Failure
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.

Full Information

First Posted
February 27, 2015
Last Updated
February 18, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02378961
Brief Title
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 16, 2015 (Actual)
Primary Completion Date
September 21, 2015 (Actual)
Study Completion Date
January 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VOX+SOF/VEL 6 wk, TN, without cirrhosis
Arm Type
Experimental
Arm Description
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
Arm Title
GS-9857+SOF/VEL 6 wk, TN, with cirrhosis
Arm Type
Experimental
Arm Description
GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
Arm Title
VOX+SOF/VEL 8 wk, TN, with cirrhosis
Arm Type
Experimental
Arm Description
GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
Arm Title
VOX+SOF/VEL 8 wk,TE, without cirrhosis
Arm Type
Experimental
Arm Description
GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
Arm Title
VOX+SOF/VEL 12 wk, TE, without cirrhosis
Arm Type
Experimental
Arm Description
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
Arm Title
GS-9857+SOF/VEL 8 wk, TE, with cirrhosis
Arm Type
Experimental
Arm Description
GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
Arm Title
VOX+SOF/VEL 12 wk, TE, with cirrhosis
Arm Type
Experimental
Arm Description
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
Intervention Type
Drug
Intervention Name(s)
VOX
Other Intervention Name(s)
GS-9857
Intervention Description
100 mg tablet(s) administered orally once daily with food
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/GS-5816, Epclusa®
Intervention Description
400/100 mg FDC tablet administered orally once daily with food
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Title
HCV RNA Change From Baseline
Time Frame
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Title
Percentage of Participants With Virologic Failure
Description
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.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Huntington Memorial Hospital Liver Center
City
Pasadena
State/Province
California
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Orlando Immunology center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
South Florida Center of Gastroenterology, P.A.
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Center for Hep C/Atlanta Medical Center
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Indianapolis Gastroenterology & Hepatology, Inc.
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Beth Isreal Deconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital and Health System
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Southwest Care Center
City
Santa Fe
State/Province
New Mexico
Country
United States
Facility Name
North Shore/Long Island Jewish PRIME
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
University of Pennsylvania Health Systems
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
UPMC Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Nashville Gastrointestinal Specialists Inc.
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Liver Institute of Virginia
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Swedish Medical
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Christchurch Clinical Studies Trust
City
Christchurch
Country
New Zealand
Facility Name
Auckland Clinical Studies
City
Grafton
Country
New Zealand
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
PubMed Identifier
27486033
Citation
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.
Results Reference
result

Learn more about this trial

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

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