The Hepatitis C Transplant Collaborative
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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'.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation [6.5 years]
To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection.
- Failure versus Cure Rate for HCV NAT+ Heart Transplants [6.5 years]
sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient
- Rate of Primary graft dysfunction (PGD) [30 days]
Rate of Expected Post-Transplant Risks
- 1 year mortality [1 Year]
Number of deaths
- Cellular graft rejection rate [6.5 years]
Graft rejection rate
- Antibody Mediated Rejection rate [6.5 years]
Graft rejection rate
Eligibility Criteria
Criteria
Inclusion Criteria:
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Recipient of a proven HCV NAT+ donor heart.
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Re-transplant patients will be included.
Exclusion Criteria:
- Multi-organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Scott & White Health Research Institute | Dallas | Texas | United States | 75246 |
Sponsors and Collaborators
- Baylor Research Institute
Investigators
- Principal Investigator: Shelley A Hall, MD FACC, BSWRI
Study Documents (Full-Text)
None provided.More Information
Publications
- Asselah T, Boyer N, Saadoun D, Martinot-Peignoux M, Marcellin P. Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int. 2016 Jan;36 Suppl 1:47-57. doi: 10.1111/liv.13027. Review.
- Englum BR, Ganapathi AM, Speicher PJ, Gulack BC, Snyder LD, Davis RD, Hartwig MG. Impact of donor and recipient hepatitis C status in lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):228-35. doi: 10.1016/j.healun.2015.10.012. Epub 2015 Oct 9.
- Gasink LB, Blumberg EA, Localio AR, Desai SS, Israni AK, Lautenbach E. Hepatitis C virus seropositivity in organ donors and survival in heart transplant recipients. JAMA. 2006 Oct 18;296(15):1843-50.
- Gottlieb RL, Hall SA. The New Direct Antiviral Agents and Hepatitis C in Thoracic Transplantation: Impact on Donors and Recipients. Curr Transplant Rep. 2018;5(2):145-152. doi: 10.1007/s40472-018-0192-y. Epub 2018 Apr 10. Review.
- Haji SA, Starling RC, Avery RK, Mawhorter S, Tuzcu EM, Schoenhagen P, Cook DJ, Ratliff NB, McCarthy PM, Young JB, Yamani MH. Donor hepatitis-C seropositivity is an independent risk factor for the development of accelerated coronary vasculopathy and predicts outcome after cardiac transplantation. J Heart Lung Transplant. 2004 Mar;23(3):277-83.
- Kim EY, Ko HH, Yoshida EM. A concise review of hepatitis C in heart and lung transplantation. Can J Gastroenterol. 2011 Aug;25(8):445-8. Review.
- Lee R, Kottilil S, Wilson E. Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy. Hepatol Int. 2017 Mar;11(2):161-170. doi: 10.1007/s12072-016-9776-8. Epub 2016 Dec 7. Review.
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