Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

October 19, 2018 updated by: Gilead Sciences

A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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

  • France
      • Clermont Ferrand, France, 63003
      • Clichy, France, 92110
      • Limoges, France, 87042
      • Toulouse, France, 31059
      • Villejuif, France, 94800

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:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic genotype 4 or 5 HCV Infection
  • Individuals may be treatment naive or treatment experienced
  • Presence or absence of cirrhosis, a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria:

  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
  • Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents

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: Genotype 4
LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection
Drug: LDV/SOF
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: Genotype 5
LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection
Drug: LDV/SOF
LDV/SOF (90/400 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 (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 LDV/SOF 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 Patients With Virologic Failure
Time Frame: Up to posttreatment Week 24

Virologic failure was defined as either:

  • 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); or

  • Relapse:

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment
Up to posttreatment Week 24
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12
Baseline; Weeks 2, 4, 8, and 12

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: Kathryn Kersey, MSc, 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

March 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1119
  • 2013-003978-27 (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
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Chronic Genotype 4 HCV

Clinical Trials on LDV/SOF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe