In the United States, individuals living with Human immunodeficiency virus (HIV)who need kidney or liver transplants can now receive organs from donors with HIV without being part of a research study. This new federal rule is expected to shorten waiting periods and broaden access to organ transplants, according to the Biden administration.
Expanding the organ donor pool
U.S. Health and Human Services Secretary Xavier Becerra stated in a news release on Tuesday, “This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with Human immunodeficiency virus.”
Prior to 2013, HIV-positive organ donations were prohibited in the U.S. HIV, which stands for human immunodeficiency virus, weakens the immune system and, if untreated, can lead to acquired immunodeficiency syndrome (AIDS). The Human immunodeficiency virus Organ Policy Equity (HOPE) Act, enacted in 2013, permitted research on organ transplants involving donors and recipients with Human immunodeficiency virus.
With the rule that took effect on Wednesday, the requirement for clinical research participation for kidney and liver transplants involving donors and recipients with HIV has been removed.
Improved management of HIV infections
Studies indicate that advances in antiretroviral drug therapy and improved management of HIV infections have made organ transplants for individuals with HIV safer and more effective.
The first successful kidney and liver transplants using organs from deceased donors with Human immunodeficiency viruswere carried out in 2016. Additionally, in 2019, a woman in Atlanta became the first living kidney donor with HIV, donating her organ to another person with the virus.
In September, the Department of Health and Human Services (HHS) proposed removing the clinical research requirement as part of its efforts to increase organ transplant access for people with Human immunodeficiency virus.
The final rule specifically addresses kidney and liver transplants, “for which the evidence is robust,” according to HHS. Meanwhile, the National Institutes of Health (NIH) is seeking public input on a proposed update to research standards for transplants involving other organs, such as heart, lung, and pancreas, from donors to recipients with HIV. The public comment period closes on December 12.
Are transplants between people with HIV safe?
The change in regulations for kidney and liver transplants is supported by data showing that these transplants between people with HIV are both safe and effective, as per HHS.
An October study published in the New England Journal of Medicine found that kidney transplantation using organs from deceased donors with HIV had similar outcomes to those using organs from donors without Human immunodeficiency virus. The research included 198 people with Human immunodeficiency viruswho received kidneys from deceased donors. Half received kidneys from donors with HIV, while the other half received kidneys from donors without the virus.
The study, conducted by researchers from Johns Hopkins University and other U.S. institutions, indicated that recipient survival rates, organ rejection risks, and other outcomes were comparable, regardless of whether the donor had Human immunodeficiency virus.
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