HHS proposes rule change for HIV-positive organ recipients
Click Here to Manage Email Alerts
Key takeaways:
- The proposed change would allow transplantation of HIV-positive kidneys or livers to HIV-positive recipients who are not involved in research.
- The proposal is based on favorable outcomes and the need for organs.
Patients with HIV in need of a kidney or liver transplant may no longer be required to participate in a clinical study to receive an organ from a donor with HIV, according to a proposed federal rule change published in the Federal Register.
HHS posted notice of the proposed change to the HOPE Act, enacted in 2013, which currently allows transplantation of organs from donors with HIV only to recipients who have HIV and who also are involved with clinical research overseen by an institutional review board.
The proposal is based on favorable outcomes and the need for organs. Image: Adobe Stock.
The Organ Procurement and Transplantation Network (OPTN) 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.
The HHS proposed rule change was based on the favorable OPTN review and “a recognition that the removal of the general research and [institutional review board] requirements for HOPE Act transplants could expand access to organ transplantation for all patients regardless of their HIV status,” according to the announcement.
The agency will take comments on the rule from the public until Oct. 15 at https://www.regulations.gov.
Reference:
Federal Register. Organ procurement and transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act. https://www.federalregister.gov/documents/2024/09/12/2024-20643/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-hope-act. Published Sept. 12. 2024. Accessed Sept. 12, 2024.
Read more about
Click Here to Manage Email Alerts