In a notice published in the Federal Register on May 8, 2015, the U.S. Department of Health and Human Services announced it will amend the OPTN Final Rule (42 CFR Part 121) to allow the recovery of transplantable organs from HIV-positive donors. This is a milestone 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 organs from HIV-positive donors to be used for HIV-positive candidates. The OPTN fully supports the HOPE Act in the interest of increasing the number of transplants, a primary strategic goal for the national transplant network.
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. Many transplant-related and HIV advocacy organizations have endorsed the HOPE Act.
At its June 1-2 meeting, in further action to support the measure, the OPTN/UNOS Board of Directors will consider a set of OPTN policies to allow the recovery and transplantation of kidneys and livers from HIV-positive donors, with specific patient safety measures intended to assure that these organs are only used for HIV-positive candidates. In addition, the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health, is leading the development of the research criteria for programs that plan to transplant HIV-positive organs into HIV-positive recipients. These additional measures will provide the framework for clinical studies to begin possibly as early as 2016.