The Department of Health and Human Services amended the OPTN Final Rule on November 27, 2024 so that:

• Transplantation of kidneys, livers and liver-kidneys from donors with HIV to candidates with HIV are no longer be required to be conducted as research, subject to the 2015 Research Criteria, and is therefore no longer required to follow National Institutes of Health (NIH) research criteria or the OPTN HOPE Act variance.
• References to people, donors and recipients with HIV are updated to be more respectful and stigma-reducing.

The NIH Final Notice, adopted on December 30, 2024, removed the requirement that kidney and liver transplants from donors with HIV require IRB-approved research protocols or compliance with NIH research criteria. For all non-liver and non-kidney transplant programs, the NIH Final Notice removed the requirements for the transplant program to complete five transplants of organs from donors without HIV to candidates living with HIV in the past four years, among other revisions to the research criteria.

A description of the policy and system changes approved by the Board can be viewed here: OPTN Policy Notice: Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates

The OPTN policy changes take effect on June 26, 2025.

Transplant programs no longer need to participate in an IRB approved clinical research protocol or the OPTN HOPE Act variance to perform transplants of livers, kidneys, or liver-kidneys from donors with HIV to candidates living with HIV. There is not any specific paperwork that must be submitted to the OPTN to begin performing these types of transplants. Transplant programs should understand the additional patient safety measures and implementation changes detailed below:

• All living and deceased kidney and liver transplant programs will be updated in the OPTN Membership System to be marked as “approved” for performing transplants for candidates living with HIV if the donor also has HIV.
  • A new requirement for kidney, liver, and liver-kidney candidates will be for a transplant physician to verify and document in the medical record that the candidate is living with HIV and willing to accept an organ from a donor with HIV. This must occur prior to the two-person reporting and verification process in the OPTN Waiting List (15.7.B and 15.7.C).
• Once these programs are approved, transplant program security administrators will be able to grant permission to users at their centers to verify that a candidate is living with HIV and willing to accept an HIV organ in the OPTN Waiting List.
• Once the candidate verification process is completed, the candidate will be eligible to appear on the match run for HIV donors.

• When a candidate receives an organ offer from a donor with a positive HIV test, a transplant physician must be the individual who confirms candidate HIV status and obtains informed consent (15.3.B)
• The informed consent process is already in policy, but the fact that a transplant physician must obtain the informed consent is new.
• Prior to transplantation, a transplant surgeon and a licensed healthcare professional must attest to HIV status of donor and candidate, and that the candidate is willing to accept an organ from a donor with HIV (5.8.A and 5.8.B)
• This is a new requirement and would be documented in the medical record.
• Living kidney or liver programs must consent their living donors with HIV about the lack of data around long-term outcomes for individuals living with HIV and donating an organ

For kidney, liver, and liver-kidney candidates, if a transplant program has previously indicated in the OPTN Waiting List that a candidate is living with HIV and willing to accept an organ from a donor with HIV, then upon implementation the transplant physician must re-verify in the candidate’s medical record that the candidate has HIV and is willing to accept an organ from a donor with HIV. Confirmation that this re-verification of candidate status and willingness to accept an organ from a donor with HIV is documented in the candidate’s medical record will occur through routine site survey. If the program identifies a change in candidate status or willingness to accept an organ from a donor with HIV, the program must update the OPTN Waiting List so that the candidate no longer shows as eligible for offers of organs from donors with HIV. Put another way, no modification is needed in the OPTN Waiting List unless candidate status or willingness to accept an organ from a donor with HIV has changed.

A small number of liver and kidney candidates verified as living with HIV and willing to accept an HIV positive organ are listed at programs with previous (but not current) IRB approval. Prior to implementation, these candidates will not be receiving organ offers from donors with an HIV positive test because the program does not have a current IRB approval. For patient safety reasons, verification will be reset for each of these liver and kidney candidates to require another verification of their willingness to accept an organ from a donor with an HIV positive organ. Requiring a verification in the system will ensure that those candidates do not suddenly begin receiving organ offers from donors with an HIV positive test result when the removal of IRB approval is implemented before the program can ensure the candidates’ willingness to accept an organ from a donor with an HIV positive test. The candidates will remain active on the list while awaiting verification and will be eligible to receive organ offers from donors without an HIV positive result.

Waiting time is not dependent on the reverification, and once reverified, these patients will receive organ offers without impact to waiting time or their position on the match. Outreach by the OPTN Contractor will ensure the transplant programs and their candidates are aware of the verification requirement ahead of implementation.

Transplant programs recovering livers and kidneys from living donors will no longer need to meet in NIH research criteria or participate in the OPTN Hope Act variance. However, these living donors would need to be consented according to Policy 14.3: Informed Consent Requirements regarding the fact that the long-term impact of donating a kidney or liver while living with HIV is unknown. Additionally, candidate consent would need to be documented in the candidate’s medical record by a transplant physician according to Policy 15.7.B: Transplant Program Requirements for Transplantation of Organs from Donors with HIV. Candidate consent must also be reconfirmed pre-transplant by a transplant surgeon and licensed healthcare provider, according to Policy 5.8.A and 5.8.B.

Yes. Only transplants involving livers and kidneys from donors with HIV are no longer required to meet NIH research criteria or participate in the OPTN HOPE Act variance. Transplant programs must be IRB approved, comply with NIH research criteria, and meet the requirements in Policy 15.7.D to perform transplants of organs other than kidneys or livers from donors with HIV.

The OPTN created an open variance (Policy 15.7.D) to evaluate HOPE Act transplants performed within a specific timeframe, as outlined in Policy 1.3: Variances. The variance has been extended from its original expiration date of January 1, 2018 to January 15, 2026, to allow more time to study the feasibility and safety of performing transplants of organs from donors with HIV to recipients with HIV.

The variance no longer applies to kidney and liver programs –it only applies to non-liver and non-kidney programs. It also no longer requires a schedule of data safety monitoring reports (DSMBs); instead, policy notes that the OPTN has the authority to collect DSMBs from transplant programs participating in the variance upon request.

The HOPE Act variance request form can be submitted by email to HOPEAct.VarianceRequest@unos.org.

A program’s approval to participate in the open variance will expire with the expiration of their IRB approval. To continue to participate, the program will need to send in a new IRB approval letter before the expiration date. Programs who lose IRB approval before the expiration date must notify the OPTN.

Any non-liver or non-kidney organ that may be recovered from a living donor with HIV would still fall under clinical research requirements. The NIH Final Notice provides updated research criteria for an intended living donation from a person with HIV if the person is donating an organ other than a liver or kidney. The revised criteria provides that deceased donor eligibility criteria apply to such transplants.

Multi-organ transplants that contain any organ other than a liver or kidney (e.g heart-kidney) must be done by a transplant program that has HOPE Act approval for the organ(s) that are not liver or kidney. These transplants must be done following NIH research criteria.

When matches are re-executed after HIV test results change to positive, only candidates from liver or kidney programs, or non-liver / non-kidney programs that are participating in the OPTN HOPE Act will be included in the match results.

Rapid screen testing for HIV, HBV, HCV

• Blood for serology testing should be drawn as early as possible at the start of a case.
• Results typically in 20-40 minutes.
• If rapid screening results are positive, a match run can be delayed until serology results are available.

In-house laboratory

• Serology results typically available within 4-6 hours.
• Automated platform expedites process.

Multiple verifications

• Multiple staff members verify test results before generating match run.
• Verifiers include supervisor on-call.

When these effective practices are not an option and it is necessary to re-execute a match run, review the following process steps, as they outline appropriate decision-making points to comply with policy.

When OPO gets new positive donor HIV test results:

• OPO stops allocation process.
• OPO enters positive test results in the OPTN Donor Data and Matching System.
• OPO withdraws any pending offers.
• OPO re-executes match run for kidney and liver only.
• OPO allocates organ.

• Review candidate or living donor's medical history and medications
• Any prior history of any opportunistic infections
• Ensure health screening and monitoring practices are up to date
• Update vaccinations
• Establish any plans for transplant immunosuppression would need to be part of the transplant discussion, considering potential pharmacokinetic interactions, i.e. protease inhibitor interactions
• Determine the need for any additional post-transplant antimicrobial prophylaxis beyond what is indicated per the transplant center’s standard post-transplant protocols
• Periodic review of candidate HIV lab results and any changes in HIV medications

• Review organ offer and consider whether changes to plan for immunosuppression are required
• Construct a contingency post-exposure antiretroviral prophylactic regimen to administer to medical staff in the event of inadvertent exposure

• Review any time HIV drugs are prescribed or changed
• Review any changes in medication to monitor potential drug interactions with HIV medications