Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

October 19, 2018 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

647

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • Sacramento, 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
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Lutherville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Novi, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • New Jersey
      • Albuquerque, New Jersey, United States
      • Berlin, New Jersey, United States
      • Hillsborough, New Jersey, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • New York
      • Binghamton, New York, United States
      • Manhasset, New York, United States
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Fayetteville, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Falls Church, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, 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:

  • Age > 18, with chronic genotype 1 HCV infection
  • HCV treatment-naive
  • HCV RNA > 10,000 IU/mL at screening
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Presence of cirrhosis
  • Coinfection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

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: LDV/SOF 8 Week
Participants will receive LDV/SOF FDC for 8 weeks.
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF+RBV 8 Week
Participants will receive LDV/SOF FDC plus RBV for 8 weeks.
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: RBV
Ribavirin (RBV) 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)
Experimental: LDV/SOF 12 Week
Participants will receive LDV/SOF FDC for 12 weeks.
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
Time Frame: Up to 12 weeks
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time Frame: Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time Frame: Week 4
Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time Frame: Week 8
Week 8
Change From Baseline in HCV RNA at Week 2
Time Frame: Baseline; Week 2
Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time Frame: Baseline; Week 4
Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Time Frame: Baseline; Week 8
Baseline; Week 8
Percentage of Participants With Sustained Virologic Response at 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 Experiencing Virologic Failure
Time Frame: Baseline to posttreatment Week 24

Virologic failure was defined as on-treatment virologic failure or virologic relapse.

  • On-Treatment 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) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Baseline 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

May 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-0108

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

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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