Kidney, liver transplants between people with HIV get green light under new HHS rule

By Jacqueline Howard, CNN

(CNN) — People in the United States who have HIV and need kidney or liver transplants can now receive organs from donors who also have HIV without having to be part of a research study. The new federal rule is expected to reduce wait times and expand access to organ transplants, according to the Biden administration.

“This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV,” US Health and Human Services Secretary Xavier Becerra said in a news release Tuesday.

Before 2013, the United States did not permit HIV-positive organ donations. HIV, the human immunodeficiency virus, attacks the body’s immune system, and if not treated, it can lead to acquired immunodeficiency syndrome or AIDS.

The HIV Organ Policy Equity (HOPE) Act, passed in 2013, allowed researchers to conduct studies of organ transplants from donors with HIV to recipients with HIV.

With the rule that went into effect Wednesday, kidney and liver transplants involving donors and recipients with HIV are no longer required to be part of clinical research.

“This new policy is a significant step forward in expanding access and reducing wait times for life-saving organ transplants for people with HIV,” Carole Johnson, administrator of the Health Resources and Services Administration, said in Tuesday’s news release.

Research suggests that the use of antiretroviral drugs and advances in managing HIV infections have helped make solid organ transplants in people with HIV safer and more efficacious.

In 2016, the world’s first kidney and liver transplantations – involving a deceased donor with HIV and recipients with HIV – were performed. Then in 2019, an Atlanta woman became the world’s first living kidney donor with HIV. She donated her organ to someone who also had HIV.

In September, HHS proposed removing the clinical research requirements in an effort to expand access to organ transplantation for people with HIV.

The final rule applies specifically to kidney and liver transplants, “for which the evidence is robust,” according to HHS. But the National Institutes of Health is seeking public comment on a proposed revision to the research criteria for the transplantation of other types of organs, such as heart, lung and pancreas, involving donors and recipients with HIV. The comment period ends December 12.

The new change in regulations for kidney and liver transplants is based on data demonstrating that these transplants between people with HIV are safe and effective, according to HHS.

One study, published in October in the New England Journal of Medicine, found that in people with HIV, kidney transplantation using organs from deceased donors who also had HIV was comparable to transplantation using organs from donors who didn’t have HIV.

The study included data on 198 people with HIV who received a kidney from a deceased person. Half of them received a kidney from a donor with HIV and the other half from a donor without HIV.

The researchers, from Johns Hopkins University and other US institutions, found that the recipients’ survival rates, risk of rejecting the donor organ and other outcomes were similar whether the donor had HIV or not.

“The safety of organs from HIV-positive donors is no longer in question; these organs result in excellent graft survival. The introduction of a second viral strain has no clinically significant effect,” Dr. Elmi Muller of Stellenbosch University in South Africa, who has performed transplantations involving donors and recipients with HIV, wrote in an editorial that accompanied the study.

“Rejection rates are lower with newer-generation HIV drugs, which have minimal interactions with immunosuppressive drugs, than with earlier HIV drugs,” she wrote. “These results will have far-reaching effects in many countries that do not perform transplantations with these organs and will create an opportunity for patients living with HIV to become organ donors, while alive or after death. Above all, we have taken yet another step toward fairness and equality for persons living with HIV.”

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