Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Overview

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Full Title of Study: “Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Interventions

  • Drug: LDV/SOF
    • 90/400 mg FDC tablet administered orally once daily

Arms, Groups and Cohorts

  • Experimental: LDV/SOF
    • LDV/SOF FDC for 6 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
    • Time Frame: Posttreatment Week 12
    • SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
    • Time Frame: Up to 6 weeks

Secondary Measures

  • Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
    • Time Frame: Posttreatment Week 4
    • SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.
  • Percentage of Participants With HCV RNA < LLOQ on Treatment
    • Time Frame: Weeks 2, 4, and 6
  • Change From Baseline in HCV RNA at Weeks 2, 4, and 6
    • Time Frame: Baseline; Weeks 2, 4, and 6
  • Percentage of Participants With Virologic Failure
    • Time Frame: Up to Posttreatment Week 12
    • Virologic failure was defined as: On-treatment virologic failure confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse) Relapse 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
  • Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
    • Time Frame: Day 1; Week 6
    • Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.
  • Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
    • Time Frame: Weeks 2, 4, 6, and Posttreatment Week 4
  • Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
    • Time Frame: Baseline; Week 6; Posttreatment Week 4

Participating in This Clinical Trial

Key Inclusion Criteria:

  • Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks – Confirmed HIV-1 infection – CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART – Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner Key Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner – Chronic liver disease of a non HCV etiology – Coinfection with hepatitis B virus (HBV) – Treatment with any investigational drug or device within 60 days of the screening visit. – History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gilead Study Director, Study Director, Gilead Sciences

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