Comments

Infinite Legacy | 04/22/2025

Infinite Legacy welcomes this chance to provide the following comments and recommendations in support and furtherance of these proposed updates to OPTN’s HIV policies. As an organization that is deeply engaged in community outreach and education, we believe clear, consistent public education about these changes is essential to fostering community understanding and trust—particularly in historically marginalized communities. Many of the same communities that are disproportionately impacted by HIV are also disproportionately affected by end-stage organ failure and face consequences and challenges resulting from longstanding myths, misconceptions, and systemic barriers related to both healthcare in general, and donation specifically.
As these policy revisions move forward, we encourage OPTN to:
1. Ensure that education and outreach efforts are culturally responsive, accessible, and tailored to meet the needs of the marginalized communities most impacted by HIV and organ failure.
2. Provide resources and guidance to OPOs to support transparent, community-centered education—including tools to help navigate conversations with donor families, transplant candidates, and the general public about HIV-positive to HIV-positive transplantation practices.
3. Prioritize transparency and clarity in public messaging to reduce stigma, address misconceptions, and build trust within diverse communities.

Cleveland Clinic | 04/22/2025

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Carrie Foote | 04/22/2025

I have been living with HIV since 1988. I was diagnosed when there were no treatments and stigma was rampant. Today, I live a full life. Not only does my treatment keep me alive and well but it also prevents me from passing on HIV sexually. My life, and others living with HIV, have normalized over the years because of advances in treaments and prevention. The ability to be an organ donor and to save a life is another step forward in not only normalizing HIV but also is a win for everyone as it increases the donor pool. I full support this proposal as it will further dismantel HIV stigma and improve lives as well as save lives of those who need life saving organs.

American Society of Transplant Surgeons | 04/22/2025

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OPTN Kidney Transplantation Committee | 04/22/2025

The OPTN Kidney Transplantation Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for its efforts on the Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates proposal. The Committee welcomes and appreciates this much needed proposal, which will expand access to organ transplant for more individuals living with HIV. The Committee looks forward to the proposal's implementation.

OPTN Patient Affairs Committee | 04/22/2025

The OPTN Patient Affairs Committee supports the proposal, and emphasizes the importance of clear communication pathways, especially for candidates at transplant programs not previously covered under the OPTN variance. Members suggested providing a summary version of the proposal to aid candidates and recipients in understanding. Additionally, they recommended including a clearly defined policy outlining when and how candidates at newly impacted programs will be notified of the changes.

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North American Transplant Coordinators Organization (NATCO) | 04/22/2025

NATCO strongly supports the revision to HIV policies to remove the research requirement for HIV positive patients to have access to these HIV positive organs, to align with Federal Regulatory Updates. The outcomes reported in the literature from the HOPE Act support the safety and efficacy of these types of transplants and patients are able to get transplanted faster than anticipated.

There have been no patient safety concerns identified for the 500 patients transplanted under the HOPE Act. There have been concerns raised regarding the patient safety with the potential increase of transplants in centers that have less experience with this special population. NATCO believes that the well-established OPTN safety reporting structure and the additional safety measures proposed by DTAC are adequate.

By utilizing these organs for these select patients, the pool of transplantable organs increases, allowing more patients to be transplanted overall. Transplant centers will need to amend informed consent policies and on-call practices to ensure compliance with the new requirements, but the work effort does not appear to be large enough to require additional staffing. OPO’s would need to ensure documentation and practices are in place, but again, does not appear to affect staffing after initial education of staff has taken place.

The Association for Multicultural Affairs in Transplantation (AMAT) | 04/22/2025

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American Society of Nephrology | 04/21/2025

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UC Davis Transplant Center | 04/21/2025

We strongly support the proposed revisions to OPTN policies eliminating the research requirement for kidney and liver transplants from HIV-positive donors to recipients living with HIV. While the policy applies to both organs, our clinical focus is on kidney transplantation, and our comments are specifically informed by the kidney literature.

There is now a robust body of evidence supporting the safety and efficacy of transplanting organs from HIV-negative donors into recipients living with HIV, where recipients have had good graft survival rates, and no increased risk of opportunistic infections or HIV progression. This was followed by the South African experience with HIV-positive donor to HIV-positive recipient transplantation, which preceded the U.S. practice by many years. Both of these have enabled the safe exploration of kidney transplantation from HIV-positive donors to people living with HIV in the U.S. Subsequently, data from the HOPE in Action study with participating U.S. transplant centers indicates that graft outcomes for HIV-positive donor to HIV-positive recipient are comparable to those of HIV-negative donor to HIV-positive recipient, with no increase in infection risk and no concerns with HIV control. The HOPE Act, which removed the ban on the use of organs from HIV-positive donors in the U.S., helped make these studies possible.

These proposed policy changes have been vital not only for people living with HIV but also for their community counterparts who may wish to pursue living donation. The OPTN policy changes are timely, evidence-driven, and will expand access to kidney transplantation for people living with HIV, while maintaining necessary safeguards.

International Society for Heart and Lung Transplantation | 04/21/2025

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National Kidney Foundation | 04/21/2025

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American Society of Transplantation | 04/21/2025

The American Society of Transplantation (AST) generally supports the proposal, “Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates,” appreciating the need to align OPTN policies with the amended OPTN Final Rule and NIH Final Notice.

The AST shares the goals of expanding transplantation in this key area but believes that clinical research studies should be established for all living donors with HIV. The AST is concerned with the removal of clinical research criteria for living kidney and liver donors with HIV who donate to candidates with HIV because the patient population of living donors with HIV who have donated is small, longer term outcomes for living donors with HIV have not yet been established, and there is a need for more data and scientific evidence to protect living donors with HIV.

Verifying the transplant candidate’s willingness to accept an organ from a donor with HIV, explaining the risks and benefits, and obtaining informed consent from the recipient after the organ offer but before transplant should follow current policy for donors with risks identified pre-transplant (Table 15-1 in OPTN Policy 15.3.8 (Donors with Risk Identified Pre-Transplant)). Requiring a transplant physician to explain the risks and obtain informed consent may add unnecessary resource use and delay to the process. The AST recommends removing "A transplant physician" from the relevant wording in the second row of proposed Table 15-1 to match the first row, i.e., "Must explain the risks and obtain informed consent from the intended recipient or the intended recipient’s agent after the organ offer but before transplant."

The AST commends the use of person-first language throughout this proposal. We suggest that the phrase “with HIV” can replace instances of “living with HIV” throughout to keep the language consistent across donors, candidates, and recipients; to keep the language consistent with the federal register HHS notice, which uses “with HIV;” because “with HIV” is accepted respectful person-first language; and the addition of “living” is not necessary.

To strengthen patient safety during early adoption outside the research setting, the OPTN should consider minimum educational criteria, training criteria, or other operational expectations for transplant programs that were not previously involved in the HOPE Act variance. There is a risk that these programs may lack experience in complex case management involving HIV-positive donors and recipients.

Finally, this proposal highlights opportunities for additional education that would benefit the transplant community. First, there is an opportunity to inform the community about the risk for transmission of drug-resistant strains of HIV through transplants from a donor with HIV to a recipient with HIV. The AST suggests the OPTN should clarify that risks related to clinically significant transmitted drug-resistant strains of HIV through transplants from a donor with HIV to a recipient with HIV are exceedingly low/hypothetical only: superinfection with donor-derived strains of HIV is not demonstrated (PMID: 31577883, PMID: 32730756, PMID: 39255037, PMID: 39403922) and drug-resistance to current preferred INSTI-containing regimens is extremely rare (PMID: 34453519). Additionally, it would be beneficial if the OPTN provides guidelines for allocation and utilization of organs from donors who have a single reactive HIV test that is presumed to be and subsequently confirmed as a false positive result. For example, should these organs always be allocated to candidates with HIV? Is additional HIV testing needed, even if not confirmatory? Resources that address this scenario would help guide OPOs and transplant programs when working through offers from donors with a single reactive HIV test.

Nina Martinez | 04/21/2025

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OPTN Liver & Intestinal Organ Transplantation Committee | 04/21/2025

The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their efforts on the Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates proposal.

The Committee supports the proposal. The Committee recommends that the definition of a transplant physician be clarified and include transplant infectious disease physicians as well as other transplant providers such as Advanced Practice Providers. The Committee also recommends that the definition of HIV positive be clarified for donors in order for organ procurement organizations to operationalize the same criteria.

Brad Zerns | 04/17/2025

I have congestive heart failure and I was delisted from [redacted] because I didn't meet ethnic rules for doctors and nurses that I had no knowledge of. Social workers without names fabricated things about me. I feel that the entire transplant committee was working to take me off the list. I guess I'll die from organ failure. Happy Easter.

American Society for Histocompatibility and Immunogenetics (ASHI) | 04/17/2025

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the proposed revisions to the policies governing the transplantation of kidneys, livers, and kidney-livers from HIV-positive donors to candidates living with HIV. ASHI is in full support of these updates, which align with federal regulations and promote equitable access to transplantation for individuals living with HIV.

Tim McDermott | 04/16/2025

This is wonderful forward progress to make organ transplants available to patients living with HIV. I trust the OPTN and transplant centers to mitigate risks and help enable this patient population to benefit from this life extending and saving surgery.

The George Washington University Hospital Transplant Institute | 04/15/2025

The George Washington University Hospital Transplant Institute thanks the OPTN Disease Transmission Advisory Committee for their efforts on this proposal, which we strongly support. We also commend the handful of centers who participate in the HOPE Act Variance, which allowed this proposal to move forward, as well as the 500+ patients who participated in these research protocols. The Washington, DC area has one of the highest rates of HIV in the United States, thus this proposal deeply affects our patient population. We have had a handful of scenarios where we have a potential living donor, who is HIV positive, interested in donating to their HIV positive partner, but has unfortunately been unable to do so due to the stringent requirements set surrounding this issue. Although an IRB process can be completed, for smaller centers like ours, the overhaul of completing an in-depth IRB is not realistic, as it is a lengthy and time-consuming process.
This policy is extremely overdue. We believe that the proposed safety requirements are both adequate and appropriate, but encourage the Committee to be prepared to adjust, once this policy goes into effect. The feasibility of this policy will be easier to assess upon the review of the monitoring reports and therefore, we encourage the Committee to continuously share this data with transplant centers. We urge the OPTN to move quickly in enacting this policy, as it will tremendously increase access to transplant to a historically marginalized population. The George Washington University Hospital Transplant Institute again thanks the Committee for this work on this proposal, especially focusing on increasing access to donor organs.

Anonymous | 04/14/2025

After working closely with our HIV transplant recipients, I have truly seen the benefits of receiving HIV+ kidney. Patients are transplanted sooner than anticipated. In addition, post-transplant patients have done well, and we have not experienced HIV related issues. Working closely with our ID team has helped us to be successful thus far.

Eric Gibney | 04/14/2025

As a transplant physician and program director at a large multi-organ transplant program that has transplanted HIV+ recipients for years, I stongly support the proposed policy. The data support that HIV+ donor organs can be utilized safely with appropriate consent/safeguards in HIV+ recipients, and removing requirements for research will allow these organs to be utilized appropriately, shortening waiting times for HIV+ recipients. We appreciate the time and effort put into making this important revision of policy.

Ken Sutha | 04/10/2025

As a nephrologist and two-time kidney transplant recipient, I strongly support the proposed updates to align policy with federal regulations in removing variance requirements for HIV kidney and liver transplants.

Research under the HOPE Act has demonstrated the safety and efficacy for people with HIV to be organ donors to people living with HIV also waiting for life saving transplants. The proposed changes not only improve health equity for people living with HIV and helps combat stigma around HIV but also shortens the waiting list for all transplant candidates by increasing the pool of transplantable organs, a win for all.

Will Rubin | 04/10/2025

I strongly support these changes!

Lacy Alonzo | 04/10/2025

As a donor family member and a recipient family member, I strongly support this proposal. This will increase health equity for special groups who may already face disparity in health care. My opinions on this matter are my own and may not reflect the opinion of the organization I work for, and I am in no way representing my organization or their stance with this comment.

Association of Organ Procurement Organizations | 04/10/2025

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Eric Altneu | 04/07/2025

I support the changes as proposed. This will open up more donor and recipient options for transplantation.

Aaron Mishkin | 04/05/2025

After review of the proposal I support the revisions to HIV policies. This proposal expands the availability of organs for transplant candidates living with HIV, in a safe and appropriate manner. I hope this measure is adopted.

Christopher Bryant | 04/02/2025

I support the proposed changes to the HOPE Act policy, as they expand organ access for candidates living with HIV while maintaining patient safety. Removing variance requirements streamlines the process, and added safeguards ensure consistency and protection. These updates reflect medical advancements and improve equity in transplantation. I strongly support their implementation.

Trate DeVolld | 03/31/2025

As a pharmacy specialist with training in both HIV care and solid organ transplant, I have seen the success of these transplants firsthand. Removing the current barrier that requires programs to use a research protocol to provide these services will provide new opportunities for centers and allow them to focus more on the needs of their patients and reduce wait time for organs. Requiring these research programs are limited in many institutions due to the costs and personnel required to manage them. Revising these policies to align with the current federal regulations will help clinicians provide the services our patients need and expand access to our communities. I strongly support this proposal.

University of Arkansas for Medical Sciences | 03/27/2025

After reviewing the proposed revisions to the HIV policy, we agree with the suggested changes. We concur that the policy should be updated to align with recent federal regulatory modifications related to HIV organ transplantation. Additionally, we fully support the inclusion of enhanced patient safety measures and the clarified language outlined in the proposal, as we believe these adjustments are essential for future implementation. Ensuring continued improvement in transplant access for all patient populations should remain a primary focus, and we appreciate and support the proposed changes.

Michael Hulburt | 03/25/2025

I fully support moving donation from individuals with HIV to recipients with HIV out of research-only protocols and into open practice.

Anonymous | 03/24/2025

I agree with the proposed changes.

Anonymous | 03/21/2025

I agree with the proposed changes. I think we've seen the life-saving potential of the HOPE Act and should move forward with this important project.

Rodney Rogers | 03/21/2025

I urge the OPTN to move forward quickly with removing the research requirement to align with the federal regulatory updates. It is important to patients to have access to these organs and for the OPTN to align with the positive outcomes reported the large clinical trials and reported in the literature

Anonymous | 03/21/2025

Yes, please allow HIV positive persons who are needing organ transplantation to obtain this lifesaving procedure. I've had a kidney-pancreas transplant for 18 years, doing well, as is my donor husband. I know I would of accepted a HIV positive kidney if I'd been HIV positive and had no donor. No question!

Anonymous | 03/21/2025

I am in support of this change.
The policy language in the living donor section is a bit confusing. Worth another review to make it clearer.