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OPTN policies and procedures implemented to support HOPE Act

Published on: Saturday, November 21, 2015

Effective Nov. 21, 2015, OPTN policies and data systems have been updated in support of the federal HIV Organ Policy Equity Act (also known as the HOPE Act), which calls for study of the feasibility, effectiveness and safety of allowing transplantable kidneys and livers from HIV-positive donors to be used for HIV-positive candidates.

Previously no organs from donors identified as HIV-positive could be used for transplant, despite the fact that a number of candidates awaiting and receiving transplants are HIV-positive. The use of HIV-positive donor organs for HIV-positive candidates is, in turn, expected to allow more organs from HIV-negative donors to be used for HIV-negative candidates.

On May 8, 2015, the U.S. Department of Health and Human Services amended the OPTN Final Rule (42 CFR Part 121) to allow the recovery of transplantable organs from HIV-positive donors. The OPTN/UNOS Board of Directors approved revisions to applicable OPTN policies on June 2, 2015, with specific patient safety measures intended to assure that these organs are only used for HIV-positive candidates.

The OPTN created a variance to ensure that HIV-positive organs are considered only for HIV-positive candidates at transplant hospitals who have received institutional review board (IRB) approval consistent with final research criteria published by the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health.

Transplant programs who receive IRB approval must submit a request to the OPTN to participate in the variance. Participating programs must specifically indicate the HIV status of each transplant candidate on their waiting list and their willingness to accept an HIV-positive kidney or liver.

Organ procurement organizations will be able to run matches for HIV- positive donors. The only candidates who will appear on match runs for these donor offers will be those listed at transplant programs that have an IRB-approved protocol, and whose HIV status and willingness to accept an HIV positive kidney or liver has been double-verified.

Access more HOPE Act information.