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Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

Primary Purpose

Hepatitis C

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

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, Genotype 1, Genotype 3, Treatment experienced

Eligibility Criteria

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

Inclusion Criteria:

  • Body mass index (BMI) ≥ 18 kg/m^2
  • HCV RNA ≥ 10000 IU/mL at screening
  • Prior treatment failure to a regimen including interferon with or without RBV
  • HCV genotype 1 or 3
  • Chronic HCV infection
  • Cirrhosis determination
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
  • Hepatitis B
  • Active drug abuse
  • Use of any prohibited concomitant medications

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SOF+VEL 25 mg (GT3) without cirrhosis

SOF+VEL 25mg+RBV (GT3) without cirrhosis

SOF+VEL 100 mg (GT3) without cirrhosis

SOF+VEL 100 mg+RBV (GT3) without cirrhosis

SOF+VEL 25 mg (GT3) with cirrhosis

SOF+VEL 25 mg+RBV (GT3) with cirrhosis

SOF+VEL 100 mg (GT3) with cirrhosis

SOF+VEL 100 mg+RBV (GT3) with cirrhosis

SOF+VEL 25 mg (GT1)

SOF+VEL 25 mg+RBV (GT1)

SOF+VEL 100 mg (GT1)

SOF+VEL 100 mg+RBV (GT1)

Arm Description

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure
Virologic failure was defined as: 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
July 17, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01909804
Brief Title
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Official Title
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 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
Keywords
Hepatitis, Genotype 1, Genotype 3, Treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+VEL 25 mg (GT3) without cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 25mg+RBV (GT3) without cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Arm Title
SOF+VEL 100 mg (GT3) without cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Arm Title
SOF+VEL 25 mg (GT3) with cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 25 mg+RBV (GT3) with cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Arm Title
SOF+VEL 100 mg (GT3) with cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Arm Title
SOF+VEL 25 mg (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 25 mg+RBV (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Arm Title
SOF+VEL 100 mg (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg+RBV (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
VEL
Other Intervention Name(s)
GS-5816
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Ribasphere®
Intervention Description
200 mg 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)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping 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 SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as: 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
Inclusion Criteria: Body mass index (BMI) ≥ 18 kg/m^2 HCV RNA ≥ 10000 IU/mL at screening Prior treatment failure to a regimen including interferon with or without RBV HCV genotype 1 or 3 Chronic HCV infection Cirrhosis determination Use of highly effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: Current or prior history of clinically significant illness other than HCV Screening ECG with clinically significant abnormalities Prior exposure to HCV specific direct acting antiviral agent Pregnant or nursing female or male with pregnant female partner Chronic liver disease of non-HCV etiology Hepatitis B Active drug abuse Use of any prohibited concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McNally
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
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Jacksonville
State/Province
Florida
Country
United States
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Miami
State/Province
Florida
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United States
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Orlando
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Florida
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United States
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Tampa
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Florida
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United States
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Wellington
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Florida
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United States
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Atlanta
State/Province
Georgia
Country
United States
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Marietta
State/Province
Georgia
Country
United States
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Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
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United States
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Baltimore
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Maryland
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Boston
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Massachusetts
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Detroit
State/Province
Michigan
Country
United States
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Hillsborough
State/Province
New Jersey
Country
United States
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Santa Fe
State/Province
New Mexico
Country
United States
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Great Neck
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
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Durham
State/Province
North Carolina
Country
United States
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Fayetteville
State/Province
North Carolina
Country
United States
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Winston-Salem
State/Province
North Carolina
Country
United States
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Portland
State/Province
Oregon
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
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Germantown
State/Province
Tennessee
Country
United States
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Nashville
State/Province
Tennessee
Country
United States
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Arlington
State/Province
Texas
Country
United States
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Dallas
State/Province
Texas
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United States
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San Antonio
State/Province
Texas
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United States
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Annandale
State/Province
Virginia
Country
United States
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Fairfax
State/Province
Virginia
Country
United States
City
Newport News
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Camperdown
State/Province
New South Wales
Country
Australia
City
Darlinghurst
State/Province
New South Wales
Country
Australia
City
Clayton
State/Province
Victoria
Country
Australia
City
Melbourne
State/Province
Victoria
Country
Australia
City
Fremantle
State/Province
Western Australia
Country
Australia
City
Perth
State/Province
Western Australia
Country
Australia
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
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 http://www.gilead.com/research/disclosure-and-transparency.
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
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.
Results Reference
result
PubMed Identifier
26551263
Citation
Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):809-17. doi: 10.7326/M15-1014. Epub 2015 Nov 10.
Results Reference
result

Learn more about this trial

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

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