HHS Proposes Rule to Increase Access to Kidney, Liver Transplants in HIV Patients

A proposed rule from the Biden administration seeks to eliminate barriers to organ transplantation in the HIV community.

If finalized, the proposed rule, announced by the administration on Thursday, would remove clinical research and institutional review board (IRB) requirements for transplanting kidneys and livers from donors with HIV to recipients who also have the virus.

“All across this country there are HIV-positive Americans who need an organ transplant and HIV-positive Americans who are ready and willing to donate,” said HHS Secretary Xavier Becerra in a press release. “Unfortunately, the process of approving those transplants is too slow and too few transplant centers participate due to burdensome requirements, resulting in unnecessary suffering for all involved.”

“Our new policy removes these requirements for HIV-positive kidney and liver transplants and will expand access to organ transplantation for people with HIV and increase overall transplant volumes for all Americans irrespective of their HIV status,” he added. “This is another important step by the Biden-Harris administration to reduce stigma and health disparities around organ transplantation, and lower healthcare costs for Americans.”

This proposed rule applies only to HIV Organ Policy Equity (HOPE) Act liver and kidney transplants. A paucity of data on HOPE Act transplants of other organs has made it more challenging to assess their safety and outcomes. Only three HOPE Act heart transplants have been granted approval, and only one has been conducted, the draft rule noted.

The NIH plans to gather experts for a working group to reconsider the research criteria used for other organs, the press release said.

Background

According to the proposed rule, the National Organ Transplant Act of 1984 was amended in 1988 to prohibit the transplantation of organs from donors with HIV.

Up until 1997, only 32 kidney transplants were completed in recipients who had HIV, all from donors without HIV. As treatment for HIV advanced, including the development of antiretroviral therapies, people with HIV lived longer and with fewer complications. Over time, stakeholders in the U.S. took notice of transplantations occurring outside the country from donors with HIV to recipients with HIV, which sparked interest in specialized HIV transplant programs here.

In 2013, the HOPE Act was signed into law, allowing organs from HIV-positive donors to be transplanted into candidates with HIV.

As noted in the proposed rule, the HOPE Act requires the HHS Secretary in partnership with the Organ Procurement and Transplantation Network (OPTN) to routinely review clinical research to determine whether the results warrant revision of the OPTN standards of quality regarding organs from donors with HIV.

In 2018, the OPTN began a review of research results relevant to HOPE Act transplants. This assessment was based on a review of studies showing the safety and outcomes of organ transplantation in recipients with HIV and the recognition that removing research and IRB requirements could increase access to organ transplantation for all patients.

An NIH-funded pilot study of 14 transplantation centers that began in 2016 found “no major differences between HOPE Act transplants of a kidney from a donor with HIV to a recipient with HIV and non-HOPE Act kidney transplants from a donor without HIV to a recipient with HIV,” the proposed rule noted.

While donors with HIV were more likely to have co-infections, “these were manageable in the larger clinical context,” the researchers found. Rejection was more common in recipients of kidneys from donors with HIV, and while the difference was not statistically significant, such concerns “merited further investigation,” they concluded.

Another NIH-funded pilot study that compared HOPE Act transplants of livers from a donor with HIV to a recipient with HIV versus non-HOPE Act liver transplants from a donor without HIV to a recipient with HIV also found no differences in 1-year graft survival, rejections, HIV breakthrough, or severe adverse events.

Those who received HOPE Act liver transplants presented with more opportunistic infections, infectious hospitalizations, and cancer, in comparison with non-HOPE Act liver transplants, prompting the study authors to suggest that these results “warrant further investigation and perhaps consideration of additional donor and recipient infection and malignancy monitoring.”

Prior to sharing its recommendations with the HHS Secretary, the OPTN also reviewed data from over 300 HOPE Act patients and found that no cases were cut short, paused, or amended due to safety concerns.

In 2021, the OPTN called for the removal of the research and IRB requirements of the HOPE Act for all organs, stating that they “present a barrier to fully realizing the potential of organ transplantation from donors with HIV to recipients with HIV.”

Public comments regarding the proposed rule are due 30 days after the publication in the Federal Register on October 15.