HHS removes barriers for HIV-positive organ recipients
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Key takeaways:
- A change to the HOPE Act allows transplantation of HIV-positive kidneys or livers to HIV-positive recipients who are not involved in research.
- The new rule is based on favorable outcomes and the need for organs.
HHS adopted a final rule eliminating the requirement that patients with HIV in need of a kidney or liver transplant participate in a clinical study to receive an organ from a donor with HIV, according to an agency press release.
The final rule amends the HOPE Act, enacted in 2013, which allowed donation of organs from people with HIV only to HIV-positive recipients participating in clinical research overseen by an institutional review board.
“This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV,” HHS Secretary Xavier Becerra, said in the release. “This evidence-based policy update demonstrates our commitment to ensuring all Americans have access to the care they need.”
As Healio previously reported, the Organ Procurement and Transplantation Network reviewed safety and outcomes from two recent pilot studies and two ongoing studies, all NIH-funded, of kidney and liver transplants involving HIV-positive donors and recipients. The organization also considered results of a study with 150 such transplants conducted between 2003 and 2009 and data from more than 300 transplants following requirements of the HOPE Act.
“Research shows that kidney and liver transplants between donors and recipients with HIV can be performed safely and effectively,” Admiral Rachel L. Levine, MD, assistant secretary for health at HHS, said in the release. “This policy change reflects our commitment to following the evidence and updating our approaches as we learn more. By removing research requirements where they are no longer needed, we can help more people with HIV access life-saving transplants.”
Reference:
Federal Register . Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act. https://www.federalregister.gov/public-inspection/2024-27410/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act. Published Nov. 27, 2024. Accessed Nov. 27, 2024.
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