People with HIV will soon be permitted to receive transplanted kidneys and livers from donors who are also infected with the virus under a new rule approved by the Biden administration.
The final rule, announced Tuesday by the Department of Health and Human Services (HHS), removes the requirement that such transplants be conducted as part of clinical research. HHS initially proposed the rule change in September.
Since 2013, when the HIV Organ Procurement Equity (HOPE) Act was signed into law, HIV-positive organ transplants have been permitted in the U.S. under certain mandated criteria for conducting research. Before that legislation was implemented, there was a federal ban on transplanting organs from donors infected with the virus.
Health officials say they hope the final rule will expand access to critical organs and reduce stigma associated with HIV, “by increasing the pool of available organs and streamlining the transplantation process,” according to a press release.
“We continue to do everything in our power to increase access to life-saving organs while addressing health inequities faced by people with HIV,” HHS Secretary Xavier Becerra said in a statement.
“This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV,” he continued. “This evidence-based policy update demonstrates our commitment to ensuring all Americans have access to the care they need.”
The rule change is supported by “robust” evidence that demonstrates the “noninferiority of kidney transplants between donors and recipients with HIV compared to transplants from donors without HIV to recipients with HIV, the release states.
While the rule change applies only to livers and kidneys, the National Institutes of Health (NIH) published a notice seeking public comment on its proposal to revise research criteria for other HOPE Act transplants of organs including heart, lung and pancreas.