A single-center pilot study evaluating the safety and efficacy of a preemptive short course of glecaprevir/pibrentasvir in hepatitis C positive to negative kidney transplantation

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 years - 99 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
    2. Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
    3. Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
    4. Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
    5. Able and willing to provide informed consent
    6. Receive an organ offer for a kidney from a deceased donor that is HCV NAT positive and meets all standard criteria for organ acceptability at NYU Langone Transplant Institute

You may not be eligible for this study if the following are true:

    1. HCV RNA positive or history of previously treated HCV
    2. Evidence of active hepatitis B infection or on active antiviral treatment of HBV
    3. HIV positivity
    4. Pregnant or nursing (lactacting) women
    5. Current use of atazanavir or rifampin
    6. Known hypersensitivity to glecaprevir and/or pibrentasvir
    7. Current or history of decompensated liver disease
    8. Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)
    9. Receive an organ offer for a kidney from a deceased donor that is:
      • Confirmed HIV positive
      • Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable hepatitis B virus DNA)
      • Known to have previously failed DAA therapy for treatment for HCV
      • HCV antibody positive, but NAT negative

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.