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

October 19, 2018 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF/VEL
SOF/VEL for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
Time Frame: Posttreatment Week 4
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
Time Frame: Posttreatment Week 24
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
Time Frame: Week 1
Week 1
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
Time Frame: Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
Time Frame: Week 4
Week 4
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
Time Frame: Week 8
Week 8
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
Time Frame: Week 12
Week 12
Change From Baseline in HCV RNA at Week 1
Time Frame: Baseline (Day 1); Week 1
Baseline (Day 1); Week 1
Change From Baseline in HCV RNA at Week 2
Time Frame: Baseline (Day 1); Week 2
Baseline (Day 1); Week 2
Change From Baseline in HCV RNA at Week 4
Time Frame: Baseline (Day 1); Week 4
Baseline (Day 1); Week 4
Change From Baseline in HCV RNA at Week 8
Time Frame: Baseline (Day 1); Week 8
Baseline (Day 1); Week 8
Change From Baseline in HCV RNA at Week 12
Time Frame: Baseline (Day 1); Week 12
Baseline (Day 1); Week 12
Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 24

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)
Up to Posttreatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2016

Primary Completion (Actual)

June 26, 2017

Study Completion (Actual)

September 13, 2017

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-1522
  • 2015-003001-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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