HCV Positive Heart Donors

NYU Langone Health25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Transplant with HCV positive donor, followed by surveillance and treatment of viremiaCOMBINATION_PRODUCT

Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Transplant Institute

New York, New York, United States

Outcomes

Primary Outcomes

Sustained Virologic Response After Treatment

Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.

Time frame: 1 year

Data from ClinicalTrials.gov

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