Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

October 19, 2018 updated by: Gilead Sciences

An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

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

  • Belgium
      • Antwerp, Belgium, 2060
      • Brussels, Belgium, 1070
  • Canada
      • Toronto, Canada, M5T 2S8
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z2C7
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
  • France
      • Clermont-Ferrand, France, 63000
      • Clichy, France, 92110
      • Creteil, France, 94000
      • Lille, France, 59037
      • Limoges, France, 87042
      • Lyon, France, 69004
      • Marseille, France, 13008
      • Paris, France, 75014
      • Pessac, France, 33604
      • Toulouse, France, 31059
      • Villejuif, France, 94804
  • Germany
      • Berlin, Germany, D-10969
      • Hamburg, Germany, 20099
      • Hannover, Germany, 30625
      • München, Germany, 81377
    • NRW
      • Koln, NRW, Germany, 50932
    • North Rhine-Westphalia
      • Duesseldorf, North Rhine-Westphalia, Germany, 40237
  • Hong Kong
      • Hong Kong, Hong Kong
  • Italy
      • Firenze, Italy, 50012
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
  • Puerto Rico
      • San Juan, Puerto Rico, 09027
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, W2 1NY
      • London, United Kingdom, NW3 2PF
      • London, United Kingdom, E1 4AT
      • Manchester, United Kingdom, M8 5RB
      • Oxford, United Kingdom, OX3 9DU
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
  • United States
    • California
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90036
      • Palo Alto, California, United States, 94304
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92154
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32610-0272
      • Jacksonville, Florida, United States, 32256
      • Miami, Florida, United States, 33136
      • Wellington, Florida, United States, 33414
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Marietta, Georgia, United States, 30066
    • Indiana
      • Indianapolis, Indiana, United States, 46237
    • Maryland
      • Baltimore, Maryland, United States, 21202
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15240
      • Pittsburgh, Pennsylvania, United States, 15213
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37211
    • Virginia
      • Richmond, Virginia, United States, 23226

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:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
  • Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
  • HCV RNA ≥ 10^4 IU/mL at screening
  • Classification as treatment naive or treatment experienced
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

  • Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
  • Screening electrocardiogram (ECG) with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at screening
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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 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 Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 24

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.
Up to Posttreatment Week 24
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Time Frame: Baseline to Week 12
Baseline to Week 12
HCV RNA Change From Baseline
Time Frame: Baseline to Week 12
Baseline to Week 12

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)

February 23, 2015

Primary Completion (Actual)

March 23, 2016

Study Completion (Actual)

June 15, 2016

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-1446
  • 2014-003898-42 (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

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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