Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)

February 8, 2019 updated by: Gilead Sciences

A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
      • Darlinghurst, New South Wales, Australia
    • Queensland
      • Herston, Queensland, Australia
    • Victoria
      • Clayton, Victoria, Australia
      • Fitzroy, Victoria, Australia
      • Melbourne, Victoria, Australia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Clermont-Ferrand, France
      • Clichy, France
      • Creteil, France
      • Grenoble, France
      • Lille, France
      • Limoges, France
      • Lyon, France
      • Marseille, France
      • Montpellier, France
      • Nice, France
      • Paris, France
      • Pessac, France
      • Rennes, France
      • Rouen, France
      • Strasbourg, France
      • Toulouse, France
      • Vandoeuvre-les-Nancy, France
      • Villejuif, France
  • Germany
      • Berlin, Germany
      • Bonn, Germany
      • Frankfurt am Main, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Köln, Germany
  • New Zealand
      • Christchurch, New Zealand
      • Grafton, New Zealand
  • Puerto Rico
      • San Juan, Puerto Rico
  • United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Nottingham, United Kingdom
      • Portsmouth, United Kingdom
  • United States
    • California
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • Pasadena, California, United States
      • Rialto, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Englewood, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Catonsville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • New Jersey
      • Hillsborough, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Murray, Utah, United States
    • Virginia
      • Falls Church, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

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
  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months)
  • Treatment experienced with a direct acting antiviral medication for HCV
  • Use of protocol specified methods of contraception

Key Exclusion Criteria:

  • Current or prior history of clinically significant illness that may interfere with participation in the study
  • Screening ECG with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at screening
  • Pregnant or nursing female
  • Chronic liver disease not caused by HCV
  • 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOF/VEL/VOX (Primary Study)
SOF/VEL/VOX for 12 weeks
Drug: SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816/GS-9857
  • Vosevi®
EXPERIMENTAL: Placebo (Primary Study)
Placebo to match SOF/VEL/VOX for 12 weeks
Drug: Placebo
Tablet administered orally once daily with food
EXPERIMENTAL: SOF/VEL/VOX (Deferred Treatment Substudy)
SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
Drug: SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816/GS-9857
  • Vosevi®

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) (Primary Study)
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 (Primary Study)
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

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

Virologic failure is 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 SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
Time Frame: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Time Frame: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
Time Frame: Up to Posttreatment Week 24 (Deferred Treatment Substudy)

Virologic failure is 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 (Deferred Treatment Substudy)

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)

November 11, 2015

Primary Completion (ACTUAL)

October 10, 2016

Study Completion (ACTUAL)

June 21, 2017

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (ESTIMATE)

November 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-367-1171
  • 2015-003455-21 (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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

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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