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

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ClinicalTrials.gov Identifier: NCT01701401
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : March 27, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Drug: LDV/SOF Drug: RBV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)

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: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants With HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
  3. Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
  4. Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
  5. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  6. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  7. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  8. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701401


  Hide Study Locations
Locations
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United States, Alabama
Birmingham, Alabama, United States
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
United States, Colorado
Aurora, Colorado, United States
Englewood, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maryland
Baltimore, Maryland, United States
Lutherville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States
Saint Paul, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, New Jersey
Hillsborough, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
United States, New York
Bronx, New York, United States
Manhasset, New York, United States
New York, New York, United States
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
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Germantown, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
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
Birmingham, Wstmid, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Jenny Yang, Pharm D Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01701401     History of Changes
Other Study ID Numbers: GS-US-337-0102
2012-003387-43 ( EudraCT Number )
First Posted: October 5, 2012    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: November 16, 2018
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

Keywords provided by Gilead Sciences:
HCV genotype 1 (GT-1)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
GS-5885
Ribavirin
Open Label
Sofosbuvir
Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:
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Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Sofosbuvir
Ledipasvir
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents