A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health

Criteria

Inclusion Criteria:

• At least 18 years of age

• Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs

• Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation

• Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage

• Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange

• Able and willing to provide informed consent

• Receive an organ offer for a kidney from a deceased donor that:

• Is HCV NAT positive

• Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute

Exclusion Criteria:

• HCV RNA positive or history of previously treated HCV

• Evidence of active hepatitis B infection or on active antiviral treatment of HBV

• HIV positivity

• Pregnant or nursing (lactacting) women

• Current use of atazanavir or rifampin

• Known hypersensitivity to glecaprevir and/or pibrentasvir

• Current or history of decompensated liver disease

• Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)

• 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