HCV Positive Heart Donors

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia

Study type: Interventional

Funder types: Other

Identifiers

NCT03382847

17-01775

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intervention arm

Experimental group

Description:

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.

Treatment:

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