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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Sites / Locations

  • Krasnoyarsk Regional Center of AIDS Prevention
  • Central Research Institute of Epidemiology
  • Central Scientific-Research Institute of Epidemiology
  • City Clinical Hospital # 24
  • First Moscow Medical University I.M.Sechenov.
  • First Moscow State Medical University I.M. Sechenov
  • Limited Liability Company "Clinic Tour"
  • Scientific Research Institute of Nutrition
  • Sklifosovsky Scientific Research Institution of Emergency Care
  • Center for Prevention and Control of AIDS and Infectious Diseases
  • Kirov Medical Military Academy
  • North-Western State Medical University named after I.I. Mechnikov
  • LLC Medical Company "Hepatolog"
  • Sahlgrenska Universitetsjukhuset
  • Karolinska University Hospital Huddinge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF/VEL

Arm Description

SOF/VEL 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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
Change From Baseline in HCV RNA at Week 1
Change From Baseline in HCV RNA at Week 2
Change From Baseline in HCV RNA at Week 4
Change From Baseline in HCV RNA at Week 8
Change From Baseline in HCV RNA at Week 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as: 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), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

Full Information

First Posted
March 24, 2016
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02722837
Brief Title
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Official Title
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
September 13, 2017 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic 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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL for 12 weeks
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
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) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
Description
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
Time Frame
Week 1
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
Time Frame
Week 2
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
Time Frame
Week 4
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
Time Frame
Week 12
Title
Change From Baseline in HCV RNA at Week 1
Time Frame
Baseline (Day 1); Week 1
Title
Change From Baseline in HCV RNA at Week 2
Time Frame
Baseline (Day 1); Week 2
Title
Change From Baseline in HCV RNA at Week 4
Time Frame
Baseline (Day 1); Week 4
Title
Change From Baseline in HCV RNA at Week 8
Time Frame
Baseline (Day 1); Week 8
Title
Change From Baseline in HCV RNA at Week 12
Time Frame
Baseline (Day 1); Week 12
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as: 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), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
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: HCV RNA ≥ 10^4 IU/mL at screening Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy Key Exclusion Criteria: Any other chronic liver disease Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Clinical hepatic decompensation Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor 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
Krasnoyarsk Regional Center of AIDS Prevention
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Central Research Institute of Epidemiology
City
Moscow
Country
Russian Federation
Facility Name
Central Scientific-Research Institute of Epidemiology
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital # 24
City
Moscow
Country
Russian Federation
Facility Name
First Moscow Medical University I.M.Sechenov.
City
Moscow
Country
Russian Federation
Facility Name
First Moscow State Medical University I.M. Sechenov
City
Moscow
Country
Russian Federation
Facility Name
Limited Liability Company "Clinic Tour"
City
Moscow
Country
Russian Federation
Facility Name
Scientific Research Institute of Nutrition
City
Moscow
Country
Russian Federation
Facility Name
Sklifosovsky Scientific Research Institution of Emergency Care
City
Moscow
Country
Russian Federation
Facility Name
Center for Prevention and Control of AIDS and Infectious Diseases
City
Saint Petersburg
Country
Russian Federation
Facility Name
Kirov Medical Military Academy
City
Saint Petersburg
Country
Russian Federation
Facility Name
North-Western State Medical University named after I.I. Mechnikov
City
Saint Petersburg
Country
Russian Federation
Facility Name
LLC Medical Company "Hepatolog"
City
Samara
Country
Russian Federation
Facility Name
Sahlgrenska Universitetsjukhuset
City
Göteborg
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden

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
Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.
Results Reference
background
PubMed Identifier
30499360
Citation
Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.
Results Reference
derived

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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

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