A meaningful change long in the works may soon be in store for some of the more than 90,000 Americans wait-listed for a kidney. The U.S. Department of Health and Human Services proposed to lift current rules mandating research and Institutional Review Board (IRB) requirements for the transplantation of HIV-positive kidneys to HIV-positive recipients, a change ASN strongly supports. 

More than 10 years ago, ASN advocated vociferously for the passage of the HIV Organ Policy Equity (HOPE) Act, which lifted the existing federal ban on the transplantation of any HIV-positive organs. According to this law, these HIV-positive kidney transplants were rigorously studied in the IRB-approved research environment, with extensive monitoring from the Organ Procurement and Transplant Network (OPTN) as well as numerous National Institutes of Health (NIH)-funded multi-center research consortium. More recently, ASN supported a 2022 recommendation from the HHS Advisory Committee on Blood and Tissue Safety and Availability to proceed with removing the research and IRB requirements, which built on input from OPTN and NIH. 

With over 300 HOPE Act transplants conducted and studied in recipients with HIV under the research requirements, no patient safety concerns have been identified, and no HOPE Act research has been halted, paused, or substantially amended to address recipient safety concerns. Crucially, there are no recorded accidental or inadvertent transmission events in the data reviewed by the OPTN, and no reports have been made to the OPTN of safety issues regarding HOPE Act transplants among OPO, hospital, or transplant center personnel or in patients, in donor hospitals, or transplant hospitals. 

This robust body of safety findings corroborate earlier research in other countries that pioneered HIV positive organ transplantation and helped inspire enactment of the HOPE Act in the United States

Advancing health equity is a top ASN priority. Gay, bisexual. and transgender people have disproportionally high rates of HIV relative to their representation in the general population, and Black and Hispanic populations are disproportionally affected by both kidney failure and by HIV. ASN believes that full HOPE Act implementation will increase access to kidney transplantation to people with kidney failure who are HIV positive, an outcome that is consistent with both ASN and HHS’ commitment to equity. 

One recent HOPE Act consortium study, which found that 70 percent of eligible HIV-positive people received an HIV-positive kidney transplant versus 43 percent of non-eligible transplant candidates, suggests the benefits of HOPE Act kidneys could substantially increase access for eligible recipients.ⁱ  Together with the finding in this study that people who received an HIV positive kidney through a HOPE Act trial had much shorter wait times (median 10.3 months versus 60.8 months) and overall higher likelihood (3.3 times greater) of transplantation, the availability of kidneys from donors with HIV clearly has the potential to increase access to transplantation among people with HIV.ⁱⁱ 

If the proposal is approved by HHS, the likely next step would be an OPTN public comment period to update OPTN rules regarding HIV-positive kidney and liver transplants, which ASN would look forward to continuing to support, together with other efforts to advocate for equitable access to kidney transplantation.

To learn more, visit www.asn-online.org/policy.

ⁱMotter JD, et al for the HOPE in Action Investigators. Wait Time Advantage for Transplant Candidates With HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act. Transplantation. March 2024.
ⁱⁱ Ibid.