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

October 19, 2018 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 2

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
    • Victoria
      • Clayton, Victoria, Australia
      • Melbourne, Victoria, Australia
    • Western Australia
      • Fremantle, Western Australia, Australia
      • Perth, Western Australia, Australia
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • California
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Pasadena, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Tampa, 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
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • New Jersey
      • Hillsborough, New Jersey, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Durham, North Carolina, United States
      • Fayetteville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Annandale, Virginia, United States
      • Fairfax, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, 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

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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+VEL 25 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Drug: RBV
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)
Other Names:
  • Ribasphere®
Experimental: SOF+VEL 100 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Drug: RBV
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)
Other Names:
  • Ribasphere®
Experimental: SOF+VEL 25 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Experimental: SOF+VEL 25 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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)
Other Names:
  • Ribasphere®
Experimental: SOF+VEL 100 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Drug: RBV
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)
Other Names:
  • Ribasphere®
Experimental: SOF+VEL 25 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Experimental: SOF+VEL 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Drug: RBV
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)
Other Names:
  • Ribasphere®
Experimental: SOF+VEL 100 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Experimental: SOF+VEL 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: VEL
Tablet administered orally once daily
Other Names:
  • GS-5816
Drug: RBV
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)
Other Names:
  • Ribasphere®

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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any 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 SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4 and 24
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

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: John McNally, 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

June 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-0109

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
  • Statistical Analysis Plan (SAP)

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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