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Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates

eye iconAt a glance

Current Policy

The 2013 HIV Organ Policy Equity (HOPE) Act has allowed organ transplantation from donors with HIV (human immunodeficiency virus) to candidates living with HIV. These transplants could only be performed by transplant programs that met and followed research protocol guidelines published by the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH). In 2024, the HHS modified the OPTN Final Rule to remove research requirements for transplantation of kidneys, livers, and liver-kidneys from donors with HIV to candidates living with HIV.

Proposed changes

  • Removes variance requirements for kidney, liver, and liver-kidney HIV transplants.
  • Adds additional patient safety measures for kidney, liver, and liver-kidney HIV transplants.
  • Ensures that policy language consistently and appropriately refers to individuals with HIV.
  • Eliminates an exception to HIV screening that may be inconsistent with patient safety goals and unnecessary because of improved organ preservation techniques.
  • Clarifies that the OPTN may request data safety monitoring reports from transplant programs participating in the HOPE Act variance.

Anticipated impact

  • What it's expected to do
    • Expand organ access to candidates living with HIV.
    • Maintain patient safety for all candidates regardless of HIV status.
  • What it won't do
    • Organs from donors with HIV will still only be available to candidates living with HIV.
    • Participation in the HOPE Act variance is still required for programs in order for their non-kidney and non-liver candidates living with HIV to receive offers for organs from donors with HIV.

Terms to know

  • HIV: Human immunodeficiency virus. The virus destroys cells in the immune system, which makes it difficult for the body to fight off infections; toxins, or poisons; and diseases. HIV causes AIDS, a late stage of the virus characterized by serious infections, malignancies and neurologic dysfunctions.
  • NIAID: National Institute of Allergy and Infections Diseases. Federal agency that conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.
  • NIH: National Institutes of Health. The primary federal agency for conducting and supporting medical research.
  • Final Rule: A federal regulation that either creates a new regulation or removes or modifies existing federal regulation.
  • Research Protocol: A document that establishes the parameters of a scientific study.
  • Variance: An OPTN Board-approved, time-limited experimental OPTN policy designed to test a hypothesis that the change will improve allocation by more effectively addressing fairness, utility, efficiency, need and/or supply. A variance must have a research plan that addresses performance measures, data collection and analysis.

Click here to search the OPTN glossary

Read the full proposal (PDF)

Provide feedback

eye iconComments

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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View attachment from Association of Organ Procurement Organizations

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.