Resources

Published 21 April 2025

• OPTN Comment

The International Society for Heart and Lung Transplantation (ISHLT) welcomes the opportunity to review the OPTN Proposal " Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates.”

ISHLT recognizes the importance of aligning transplant policies with evolving regulatory frameworks while ensuring both patient safety and equitable access to life-saving transplantation. Our comments focus on the proposed elimination of experience requirements for heart and lung transplant centers performing HIV-positive organ transplants and the potential implications of expanded consent and documentation requirements.

We strongly support the amended Final Rule and revised NIH research criteria which are intended to expand access and provide benefits to people living with HIV, while continuing to ensure safety and data collection to enhance practice. These revisions will remove the requirement for thoracic transplant programs to meet previous NIH regulations of the requirement of five transplants of organs from donors who do not have HIV to candidates living with HIV over a four-year period. This restrictive criteria was not based on medical evidence and in practice has meant that very few centers have been eligible, greatly reducing access to HIV +/+ thoracic transplant only to those living with HIV who live in close proximity to participating centers1. In alignment with this trajectory, ISHLT supports the removal of experience requirements as a means to broaden access to transplantation for patients living with HIV. This expansion should be accompanied by appropriate safeguards to ensure optimal patient outcomes.

We note that the proposed consent and documentation requirements for kidney and liver transplants introduce multiple levels of verification, potentially creating administrative burdens without evidence to support the safety benefits. We understand the need for additional safety measures as we are expanding access, however, with over 500 kidney and liver HIV donor +/HIV recipient + performed, there have not been any safety events 2,3. While this proposal does not yet impact thoracic transplantation, ISHLT advises caution against implementing similarly stringent measures for heart and lung programs in the future, as these could deter center participation without demonstrable improvements in patient safety.

We believe the policy document should clarify that for thoracoabdominal dual organ transplants a center must have an open variance for thoracic transplantation under the HOPE Act in order to perform a Heart-Kidney or Heart-Liver transplant, for example. If a patient is listed for kidney transplantation and consented to accept HIV+ donors, and was subsequently listed for heart transplant, HIV+ donors could only be utilized at a center with an open variance for heart transplantation. Clarification of this in the policy may avoid any confusion.

Additionally, we would urge the OPTN to ask the NIH and HRSA to be transparent with the thoracic community with regards to the clinical endpoints they believe they need to see from HOPE Act thoracic transplants, that would allow centers to perform thoracic HIV +/+ transplantation outside of the research umbrella in the future. Historically, thoracic transplant research has been limited by lower volume compared to liver and kidney transplantation. Consequently, clinical decision making has relied more heavily on observational data, expert consensus, and institutional experience. We hope this would not limit and prolong the eventual elimination of the requirement for HOPE Act Variance for thoracic transplantation.

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1. Bowring MG, Ruck JM, Bryski MG, Werbel W, Tobian AAR, Massie AB, Segev DL, Durand CM Impact of expanding HOPE Act experience criteria on program eligibility for transplantation from donors with human immunodeficiency virus to recipients with human immunodeficiency virus. Am J Transplant. 2023 Jun;23(6):860-864.
2. Durand CM, Zhang W, Brown DM, Yu S, Desai N, Redd AD, Bagnasco SM, Naqvi FF, Seaman S, Doby BL, Ostrander D, Bowring MG, Eby Y, Fernandez RE, Friedman-Moraco R, Turgeon N, Stock P, Chin-Hong P, Mehta S, Stosor V, Small CB, Gupta G, Mehta SA, Wolfe CR, Husson J, Gilbert A, Cooper M, Adebiyi O, Agarwal A, Muller E, Quinn TC, Odim J, Huprikar S, Florman S, Massie AB, Tobian AAR, Segev DL; HOPE in Action Investigators. A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action. Am J Transplant. 2021 May;21(5):1754-1764. doi: 10.1111/ajt.16205. Epub 2020 Aug 8. PMID: 32701209; PMCID: PMC8073960.
3. Durand CM, Florman S, Motter JD, Brown D, Ostrander D, Yu S, Liang T, Werbel WA, Cameron A, Ottmann S, Hamilton JP, Redd AD, Bowring MG, Eby Y, Fernandez RE, Doby B, Labo N, Whitby D, Miley W, Friedman-Moraco R, Turgeon N, Price JC, Chin-Hong P, Stock P, Stosor V, Kirchner VA, Pruett T, Wojciechowski D, Elias N, Wolfe C, Quinn TC, Odim J, Morsheimer M, Mehta SA, Rana MM, Huprikar S, Massie A, Tobian AAR, Segev DL; HOPE in Action Investigators. HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV. Am J Transplant. 2022 Mar;22(3):853-864. doi: 10.1111/ajt.16886. Epub 2021 Nov 25. PMID: 34741800.