New rules published Wednesday by the US Department of Health and Human Services (HHS) will guide research surrounding organ transplants between HIV-positive donors and recipients.
The change reflects the new reality of HIV: Antiretroviral drug cocktails have made near-normal lifespans possible for those with the virus, and as they are living longer, they are also developing the kinds of chronic diseases that necessitate organ transplants.
Federal regulations have banned people with HIV from donating organs since 1988, after several recipients of donated organs became infected. This ban extended to research on HIV-positive organ transplants as well.
The HIV Organ Policy Equity (HOPE) Act, signed in 2013, changed that policy, allowing scientists to study transplants from HIV-positive donors to HIV-positive recipients.
“As our understanding of HIV and effective treatments have grown, that [previous] policy has become outdated,” President Barack Obama said at the bill’s signing.
While HIV-positive patients do get transplants from uninfected donors, they are often disqualified from regular transplant lists because their infection can complicate the transplant process, from pre-surgical immunizations to post-surgery immunosuppression.
Studies indicate that HIV-positive organ transplantation can be life-saving for patients. A study published earlier this year in the New England Journal of Medicine followed 27 HIV-positive South African patients after they received kidney transplants from deceased HIV-positive donors. The patients had a survival rate of 84 percent at one year and 74 percent at five years. Their HIV infections remained well controlled, with undetectable virus after the transplantation.
The rules published Wednesday will guide future such clinical trials in the United States, including how patients should be informed of the procedure’s risks, where the surgery could be carried out, and whether living donors can donate. (They can.)
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, which led the development of the HHS criteria, said such clinical trials could begin as early as 2016.