To the Editor:
The HIV Organ Policy Equity (HOPE) Act, implemented on November, 25, 2015, allows hospitals to transplant organs from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+).1 Currently, regulations stipulate that these transplants can only be performed under institutional review board-approved protocols, with an Organ Procurement and Transplantation Network (OPTN) variance, and if the transplant team meets “experience criteria,” or a “minimum combined experience of the transplant physician and HIV physician on the team [of] 5 organ-specific cases over 4 years.”1
Given the low number of programs performing HIV D+/R+ transplants, and reconsideration of HOPE research criteria by the Department of Health and Human Services Secretary, OPTN, and transplant community,2 we aimed to understand the impact of experience criteria on HIV D+/R+ transplantation.
We used the Scientific Registry of Transplant Recipients data from November, 25, 2015, to January, 1, 2022, to quantify the number of programs eligible to perform HIV D+/R+ transplantation under the current vs expanded criteria. The existing regulatory language does not specify whether experience criteria refer to new transplant surgeries from donors without HIV to recipients with HIV (HIV D−/R+) (surgical experience) or HIV D−/R+ recipients currently in care (medical experience). Thus, we determined each program’s eligibility using both surgical and medical approaches to experience. Expanded criteria included reducing minimum required cases and/or removing the organ-specific requirement. For comparison, we report the number of programs with OPTN variances to perform HIV D+/R+ transplantation as of October 31, 2022.3
As of October 2022, 11%, 18%, 1%, 0%, and 0% of kidney, liver, heart, lung, and pancreas programs have OPTN variances to perform HIV D+/R+ transplantation (Table). However, using the surgical approach, 33%, 14%, 1%, 0%, and 0% of the respective programs met the current experience criteria by January 2022 (Fig.). Using the medical approach, 40%, 26%, 1%, 3%, and 0% of the respective programs met the current experience criteria by January 2022. The medical approach allowed programs to become eligible sooner under the current and expanded criteria. If the experience criteria were expanded to ≥1 HIV D−/R+ transplant, 63%, 57%, 39%, 39%, and 5% of the respective programs would be eligible. If the organ-specific requirement was removed, 43%, 59%, 53%, 80%, and 64% of the respective programs would be eligible.
Table.
Cumulative number of kidney, liver, heart, lung, and pancreas transplant programs that would be eligible under the current and expanded HOPE Act experience criteria using surgical and medical experience by January 2022.
| HIV+ experience criteria | Kidney programs N = 251a |
Liver programs N = 147 | Heart programs N = 148 | Lung programs N = 74 | Pancreas programs N = 122 |
|---|---|---|---|---|---|
| Surgical experienceb | |||||
| Current, n (%) | |||||
| 5 organ-specific cases in 4 y | 83 (33) | 20 (14) | 1 (1) | 0 (0) | 0 (0) |
| Expanded, n (%) | |||||
| 1 organ-specific case in 4 y | 156 (62) | 80 (54) | 55 (37) | 29 (39) | 6 (5) |
| 3 organ-specific cases in 4 y | 110 (44) | 44 (30) | 13 (9) | 4 (5) | 0 (0) |
| 5 any-organ-specific cases in 4 y | 91 (36) | 77 (52) | 70 (47) | 55 (74) | 69 (57) |
| Medical experiencec | |||||
| Current, n (%) | |||||
| 5 organ-specific recipients in 4 y | 100 (40) | 38 (26) | 2 (1) | 2 (3) | 0 (0) |
| Expanded, n (%) | |||||
| 1 organ-specific recipient in 4 y | 159 (63) | 84 (57) | 58 (39) | 29 (39) | 6 (5) |
| 3 organ-specific recipients in 4 y | 122 (49) | 56 (38) | 16 (11) | 5 (7) | 0 (0) |
| 5 any-organ-specific recipients in 4 y | 109 (43) | 86 (59) | 78 (53) | 59 (80) | 78 (64) |
| Active OPTN variancesd, n (%) | 28 (11) | 26 (18) | 2 (1) | 0 (0) | 0 (0) |
HIV, human immunodeficiency virus; HIV D−/R+; transplant from donor without HIV to recipient with HIV, HOPE, HIV Organ Policy Equity; OPTN, Organ Procurement and Transplantation Network.
Denominator of kidney, liver, heart, lung, and pancreas programs determined by the number of programs that performed at least one transplant of that organ type during the study period irrespective of recipient HIV status.
Surgical experience based on the number of HIV D−/R+ transplant procedures performed over the previous 4 years.
Medical experience based on the number of living HIV D−/R+ transplant recipients ever transplanted at that hospital and cared for over the previous 4 years.
Determined from the published list of transplant programs with active OPTN variances as of October 31, 2022.3
Figure.
Number of eligible transplant programs under the current and expanded HOPE Act experience criteria using the surgical and medical experience to determine eligibility; November 2015–January 2022. Total number of kidney, liver, heart, lung, and pancreas programs (maroon horizontal line) determined by the number of programs that performed at least one transplant, irrespective of recipient HIV status, of that organ type during the study period. Surgical experience based on the number of HIV D−/R+ transplant procedures performed over the previous four years at that hospital. Medical experience based on the number of HIV D−/R+ transplant recipients ever transplanted at that hospital and alive at any point over the previous four years. Surgical and medical experience counted for each program for each day from 11/25/2015 to 1/1/2022. For the context of this study, once a program met the requirements for a given criterion, the program remained eligible according to that criterion.
In this study of US transplant programs, we found the following aspects: (1) 28%, 68%, 100%, and 0% of currently eligible kidney, liver, heart, and lung programs have OPTN variances to perform HIV D+/R+ transplantation, (2) lowering the HOPE experience criteria threshold to ≥1 HIV D−/R+ transplant of the same organ would allow the largest number of kidney and liver programs to become eligible, and (3) removing the organ-specific component would allow the largest number of heart, lung, liver, and pancreas programs to become eligible.
Early results of HIV D+/R+ kidney and fiver transplantation are encouraging.4,5 Accordingly, a federal advisory committee recommended removal of research requirements for kidney and fiver transplantation and reconsideration of requirements for heart, lung, and pancreas transplantation. These recommendations are under review by the Secretary of the Department of Health and Human Services.2
Our findings highlight the role of experience criteria in limiting participation in HIV D+/R+ transplantation, particularly for cardiothoracic transplantation with a single HIV D+/R+ heart transplant performed to date.6 We also highlight the gap between eligible and participating programs, suggesting that additional barriers remain. As the transplant community moves forward, we must continue to identify and address barriers along the care continuum for people with end-stage organ disease and HIV.
Acknowledgments
The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. The data reported here have been supplied by the Hennepin Healthcare Research Institute as the contractor for the Scientific Registry of Transplant Recipients (SRTR). The Health Resources and Services Administration, US Department of Health and Human Services, provides oversight to the activities of the Organ Procurement and Transplantation Network and SRTR contractors. The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy of or interpretation by the SRTR or the US government.
Funding
This work was supported by grant T32GM13677 (Bowring) from the National Institute of General Medical Scientists Medical Scientist Training Program, U01AI134591 (Durand/Segev), U01AI138897 (Durand/Segev), and R01AI120938 (Tobian), K23AI157893 (Werbel) from the National Institute of Allergy and Immunology, and K24DK101828 (Segev) and R01DK132395 (Massie) from the National Institute of Diabetes and Digestive and Kidney Diseases.
Footnotes
Disclosure
The authors of this manuscript have conflicts of interest to disclose as described by the The American Journal of Transplantation. C.M. Durand reports serving on a grant review committee for Gilead Sciences. D.L. Segev reports speaking honoraria from Novartis and Sanofi and consulting for Sanofi, Novartis, and CSL Behring. The remaining authors have no conflicts of interest to disclose as described by The American Journal of Transplantation.
References
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