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

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ClinicalTrials.gov Identifier: NCT02081079
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : January 14, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Genotype 4 HCV Chronic Genotype 5 HCV Drug: LDV/SOF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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




Primary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]


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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:

  • 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

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): NCT02081079


Locations
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France
Clermont Ferrand, France, 63003
Clichy, France, 92110
Limoges, France, 87042
Toulouse, France, 31059
Villejuif, France, 94800
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Kathryn Kersey, MSc 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: NCT02081079     History of Changes
Other Study ID Numbers: GS-US-337-1119
2013-003978-27 ( EudraCT Number )
First Posted: March 7, 2014    Key Record Dates
Results First Posted: January 14, 2016
Last Update Posted: November 19, 2018
Last Verified: April 2016
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 GT 4
HCV GT 5

Additional relevant MeSH terms:
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Sofosbuvir
Ledipasvir
Antiviral Agents
Anti-Infective Agents