The Biden administration has announced a significant policy change, now allowing individuals with HIV to receive life-saving kidney and liver transplants from donors who are also HIV-positive. This decision, revealed by the Department of Health and Human Services (HHS) on Tuesday, November 26, 2024, is grounded in robust evidence confirming the safety and efficacy of such transplants. The new rule aims to broaden access to organ transplantation and reduce waiting times for HIV-positive patients in need.
Policy Shift Based on Solid Evidence
Prior to this change, HIV-positive to HIV-positive transplants were permitted only within the confines of research studies. The updated policy eliminates the requirement for clinical research and institutional review board (IRB) approvals, streamlining the process and making these transplants more readily available.
Carole Johnson, administrator of the Health Resources and Services Administration (HRSA), emphasized the importance of this policy shift, stating, “This new policy is a significant step forward in expanding access and reducing wait times for life-saving organ transplants for people with HIV.”
Favorable Outcomes in Transplant Studies
HHS highlighted that studies have demonstrated equivalent outcomes in kidney transplants between HIV-positive donors and recipients compared to transplants from HIV-negative donors to HIV-positive recipients. This finding underscores the viability and success of HIV-positive to HIV-positive organ transplantation.
Historical Context and Expansion Considerations
Organ transplants involving HIV-positive donors have been conducted since 2010, initially in South Africa. The United States began performing these procedures as part of research studies in 2013, with over 500 such transplants completed to date. In 2019, surgeons at Johns Hopkins University performed the world’s first kidney transplant from a living HIV-positive donor to an HIV-positive recipient.
Currently, the policy change applies specifically to kidney and liver transplants. However, HHS is considering expanding the scope to include other organs such as the heart, lung, and pancreas. The department is soliciting public feedback on potential revisions to research rules governing HIV-to-HIV organ transplants for these additional organs.