HCV Positive Heart Donors

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment. | Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia<br>* Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response After Treatment | Percentage of patients with sustained virologic response after treatment for HCV after heart transplant. | 1 year |