Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

October 19, 2018 updated by: Gilead Sciences

An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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, 2050
  • France
      • Clichy, France, 92110
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • Spain
      • Barcelona, Spain, 08028
  • United States
    • California
      • Beverly Hills, California, United States, 90210
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90069
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92103
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32256
      • Miami, Florida, United States, 33136
      • Orlando, Florida, United States, 32803
      • Wellington, Florida, United States, 33414
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Downers Grove, Illinois, United States, 60515
    • Indiana
      • Indianapolis, Indiana, United States, 46237
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Maryland
      • Baltimore, Maryland, United States, 21229
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Springfield, Massachusetts, United States, 01105
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
    • Missouri
      • Kansas City, Missouri, United States, 64131
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Binghamton, New York, United States, 13903
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10029
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Germantown, Tennessee, United States, 38138
    • Texas
      • San Antonio, Texas, United States, 78215
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23226
    • Washington
      • Seattle, Washington, United States, 98111

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
  • Infection with HCV genotype 1
  • HCV RNA > LLOQ at screening
  • Participation in a prior Gilead-sponsored study
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male
  • Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
  • Hepatocellular carcinoma (HCC)
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDV/SOF+RBV 12 weeks (Group 1)
Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: 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)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.
Experimental: LDV/SOF 24 weeks (Group 2)
Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF+RBV 24 weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
Drug: LDV/SOF
Tablet(s) administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: 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)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.

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: Post-treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Post-treatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 Weeks
Up to 24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 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 treatment, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in HCV RNA From Baseline
Time Frame: Baseline to Week 8
Baseline to Week 8
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 confirmed with 2 consecutive values or last available posttreatment 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

July 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1118
  • 2014-001245-24 (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

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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