A new federal rule allows people living with HIV in the United States to receive kidney or liver transplants from HIV-positive donors without participating in research studies. The policy, announced by the Biden administration, is a landmark step aimed at reducing wait times and increasing access to life-saving transplants.
“This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV,” stated Xavier Becerra, Secretary of Health and Human Services (HHS).
Until 2013, HIV-positive organ donations were prohibited in the U.S. due to concerns about transmission and health outcomes. The passing of the HIV Organ Policy Equity (HOPE) Act in 2013 allowed researchers to study the feasibility and safety of organ transplants between HIV-positive donors and recipients. However, such transplants were restricted to clinical research trials.
Effective this week, the new rule eliminates that restriction for kidney and liver transplants, reflecting advancements in HIV treatment and transplant medicine. According to Carole Johnson, Administrator of the Health Resources and Services Administration, “This policy is a significant step forward in expanding access and reducing wait times for life-saving transplants for people with HIV.”
Modern antiretroviral therapies and improved HIV management have made these transplants not only viable but also safe and effective. Research has consistently shown comparable outcomes between organ recipients with HIV who receive organs from HIV-positive donors and those receiving organs from HIV-negative donors.
A pivotal study published in The New England Journal of Medicine in October assessed the outcomes of 198 kidney transplant recipients with HIV. Half received kidneys from HIV-positive donors, and the other half from HIV-negative donors. The results revealed no significant differences in survival rates, rejection risks, or other key outcomes.
These findings align with international experiences. Dr. Elmi Muller of Stellenbosch University in South Africa, a pioneer in HIV-positive organ transplants, noted that modern HIV treatments reduce rejection rates and ensure excellent graft survival. “The safety of organs from HIV-positive donors is no longer in question,” she wrote, emphasizing the broader implications for global organ donation practices.
While the current regulation focuses on kidney and liver transplants due to robust evidence, the National Institutes of Health is exploring expanding this policy to include other organs such as the heart, lungs, and pancreas. Public comments on this proposal are open until December 12.
This rule marks a critical step in addressing disparities in healthcare access and underscores a commitment to equity for individuals living with HIV. It also opens doors for HIV-positive individuals to contribute as organ donors, either during their lifetime or after death, further strengthening the transplant system.