HCV Positive Heart Donors
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/17/2019 |
| Start Date: | January 5, 2018 |
| End Date: | October 22, 2019 |
| Contact: | Alex Reyentovich, MD |
| Email: | Alex.Reyentovich@nuymc.org |
| Phone: | 646-501-0119 |
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.
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
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