Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Chro

Brief Summary: 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.

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Proportion of participants with sustained virologic response 12 weeks after completion of treatment (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Incidence of any adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 6 weeks ]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Proportion of participants with sustained virologic response 4 weeks after discontinuation of study treatment (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.
  • The proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 6 Weeks ]
  • HCV RNA change from Day 1 [ Time Frame: Up to 6 Weeks ]
  • The proportion of participants with virologic failure [ Time Frame: Up to Posttreatment Week 12 ]

    • 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 [ Time Frame: Day 1; Week 6 ]
  • Proportions of participants that maintain HIV-1 RNA < 50 copies/mL while on HCV treatment and at Posttreatment Week 4 [ Time Frame: Up to Posttreatment Week 4 ]
    This endpoint will be measured for participants who are receiving antiretroviral therapy for HIV-1.
  • Change from baseline on CD4 T-cell count at the end of treatment and at Posttreatment Week 4 [ Time Frame: Baseline; Week 6; Posttreatment Week 4 ]


Information By: Gilead Sciences

Dates:
Date Received: May 27, 2015
Date Started: June 2015
Date Completion:
Last Updated: January 6, 2017
Last Verified: January 2017