The Hepatitis C Transplant Collaborative
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transplant; Failure, Heart, Hepatitis C. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nationwide Hepatitis C NAT+ Cardiac Transplant Experience
Overview
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
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'.
Primary outcome measures
- Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation [Time frame: 6.5 years]
- Failure versus Cure Rate for HCV NAT+ Heart Transplants [Time frame: 6.5 years]
- Rate of Primary graft dysfunction (PGD) [Time frame: 30 days]
- 1 year mortality [Time frame: 1 Year]
- Cellular graft rejection rate [Time frame: 6.5 years]
- Antibody Mediated Rejection rate [Time frame: 6.5 years]
Eligibility criteria
Inclusion criteria
- Recipient of a proven HCV NAT+ donor heart.
- Re-transplant patients will be included.
Exclusion criteria
1\. Multi-organ transplantation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Baylor Scott & White Health Research Institute — Dallas
Publications
- 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. doi: 10.1155/2011/947838. PMID 21912770
- 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. PMID 26615769
- 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. doi: 10.1001/jama.296.15.1843. PMID 17047214
- 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. doi: 10.1016/S1053-2498(03)00148-7. PMID 15019636
- 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. PMID 27928718
- 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. PMID 26725897
- 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. PMID 29774177
Identifiers
NCT: NCT04493385 · 019-297