The Hepatitis C Transplant Collaborative

Study Overview
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Brief Summary
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In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

Detailed Description
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Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks [1, 2]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed [3-5]. These DAAs target multiple steps in the HCV replication life cycle [6]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments. As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool [7]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last  2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Official Title
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Nationwide Hepatitis C NAT+ Cardiac Transplant Experience

Conditions
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Transplant; Failure, Heart, Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient of a proven HCV NAT+ donor heart. Re-transplant patients will be included. Exclusion Criteria: 1. Multi-organ transplantation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation | To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection. | 6.5 years | 
| Failure versus Cure Rate for HCV NAT+ Heart Transplants | sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient | 6.5 years | 
| Rate of Primary graft dysfunction (PGD) | Rate of Expected Post-Transplant Risks | 30 days | 
| 1 year mortality | Number of deaths | 1 Year | 
| Cellular graft rejection rate | Graft rejection rate | 6.5 years | 
| Antibody Mediated Rejection rate | Graft rejection rate | 6.5 years |