The U.S. Department of Health and Human Services (HHS) announced a final rule that will expand access to kidney and liver transplants for people with HIV by removing clinical research requirements for these transplants.
The final rule, which further implements the HIV Organ Policy Equity (HOPE) Act, removes the clinical research and institutional review board (IRB) approval requirements for kidney and liver transplants between donors with HIV and recipients with HIV. This change is based on research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV.
The final rule applies specifically to kidney and liver transplants, for which the evidence is robust, and shows the power of biomedical evidence to inform policy. The HOPE Act expansion was driven by a large body of evidence, much of which was funded by the National Institutes of Health (NIH) and HHS, including recent findings from an NIH-funded study demonstrating noninferiority of kidney transplants between donors and recipients with HIV compared to transplants from donors without HIV to recipients with HIV.
In tandem with the final rule, the NIH published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung, and pancreas. This effort aims to streamline the HOPE Act research requirements and continue to build an evidence base of outcomes data on HOPE Act transplants of organs other than livers and kidneys.
