Modify HOPE Act Variance to Include Other Organs Ad Hoc Disease Transmission Advisory Committee

What problem will the proposal solve? Current variance (2015) limited to liver and kidney recipients Proposal will allow additional organs to be transplanted from HIV positive donors Still ensures patient safety by adherence to policy requirements and federal research criteria Increases the number of transplants with broader use of HIV positive organs The HIV Organ Policy Equity Act was enacted on November 21, 2013, permitting use of organs from HIV- positive donors for transplantation into HIV-positive candidates under approved research protocols. Policy variance created by OPTN/UNOS in 2015 did put this law into practice for liver and kidney only. Programs must apply to the OPTN/UNOS and adhere to research protocol created by the National Institutes of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH).  The NIH statement specifically indicated that the intention was not to limit the practice to only liver and kidney. In the last few years, members have been requesting expansion of the program. No clinical outcomes have been reported that would prevent expansion.

What are the proposed solutions? Include additional organs in infectious disease screening and verification process for donors that are HIV positive Ensure adherence to federal research criteria and patient safety HIV positive extra vessels: clarifies use and storage prohibition This proposal is essentially applying existing policy to all other organs. The policy itself remains unchanged. Any language that was specific to “liver and kidney” was changed to include all organs. Additionally, language was added to clarify use of and prohibition of storage of vessels for HIV-positive donor to HIV positive recipients. ---------------------------------------------------------------------------------------------------------------------------------------------------------------- **If there are questions, here are the policy language references: 5.3B Infectious Disease Criteria, 5.4E Allocations to Candidates Not on the Match Run 5.5C OPO Requirements for Positive HIV Results, 15.7C Transplant Hospital Requirements for Transplantation of HIV Positive Organs 16.6 Extra Vessels Transplant and Storage

How will members implement this proposal? Transplant Hospitals (requirements have not changed): Must continue to meet required experience and participate in research study; Must develop protocol and submit data to the OPTN/UNOS OPOs: Train staff to expand pool of organs evaluated and potentially recovered Requirements for transplant hospitals participating in an IRB-approved research protocol remain, as does submission of data to the OPTN/UNOS. Experience requirements in performing transplants into HIV-positive recipients also remain. Additional reporting and protocol development many be required to expand programs to additional organ types. OPOs may need to modify to accommodate expansion of program and volume of offers which should still be a small percentage in comparison to all transplants.

How will the OPTN implement this proposal? System programming changes include: Allow candidates to indicate willingness to accept HIV positive organs in WaitlistSM (beyond liver or kidney) Modify DonorNet® to allow HIV positive donor to HIV positive recipient matches beyond liver and kidney Continue to monitor candidates added, donors recovered, and transplants occurring under the HOPE Act OPTN/UNOS Programing is considered a “large” implementation effort, as additional options must be added to Waitlist and DonorNet.

Questions?

Supporting Evidence 2017: 19 transplants (12 kidney and 7 liver) under the HOPE Act variance, compared to 19,849 kidney and 8,082 liver transplants (deceased and living transplants total) overall These 19 transplants represent less than 1% of all transplants in 2017; this proposal allows the program to contribute to a greater percentage of HIV positive transplants to annual overall transplants NO reported clinical outcomes so far indicate safety concerns that would prevent expansion of the variance