Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

October 19, 2018 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

870

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

  • France
      • CHRU Lille, France
      • Clichy, France
      • Creteil, France
      • La Tronche, France
      • Lyon, France
      • Marseille, France
      • Nice, France
      • Paris, France
  • Germany
      • Berlin, Germany
      • Dusseldorf, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Koln, Germany
      • Mainz, Germany
  • Italy
      • Bologna, Italy
      • Brescia, Italy
      • Milan, Italy
      • Padova, Italy
      • Palermo, Italy
      • Roma, Italy
      • San Giovanni Rotondo, Italy
      • Torino, Italy
  • Puerto Rico
      • San Juan, Puerto Rico
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Santander, Spain
      • Sevilla, Spain
  • United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Plymouth, United Kingdom
    • Wstmid
      • Birmingham, Wstmid, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • La Jolla, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • Sacramento, California, United States
      • San Diego, 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
      • Tampa, 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
    • Maryland
      • Baltimore, Maryland, United States
      • Lutherville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • New Jersey
      • Hillsborough, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
      • Santa Fe, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • Manhasset, New York, United States
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Durham, North Carolina, United States
      • Fayetteville, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Falls Church, 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
  • Cirrhosis determination; a liver biopsy may be required
  • 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
  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • 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 12 weeks
LDV/SOF administered for 12 weeks
Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF+RBV 12 weeks
LDV/SOF+RBV administered for 12 weeks.
Drug: RBV
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)
Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF 24 weeks
LDV/SOF administered for 24 weeks
Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: LDV/SOF+RBV 24 weeks
LDV/SOF+RBV administered for 24 weeks.
Drug: RBV
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)
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 Study Drug (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.
Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
Time Frame: Up to 24 weeks
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Up to 24 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 SVR at 4 and 24 Weeks After Discontinuation of Study Drug
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Time Frame: Baseline to posttreatment Week 24

On-treatment virologic failure was defined as:

  • Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR
  • Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR
  • Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Baseline 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: Jenny Yang, Pharm D, 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

September 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-0102
  • 2012-003387-43 (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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