HCV Positive Heart Donors

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret

Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.

Inclusion Criteria:

• Listed for an isolated heart transplant at NYU Langone Health
• Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
• No active illicit substance abuse
• Weight at least 50kg
• Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
• Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
• Able and willing to provide informed consent

Exclusion Criteria:

• HIV positive
• HCV RNA positive or history of previously treated HCV
• Hepatitis B surface antigen positive or on active antiviral treatment for HBV
• Pregnant or nursing (lactating) women
• Use of strong CYP3A inducers