Individuals with HIV will no longer be prohibited from donating organs in the U.S. HHS on Friday lifted a regulatory hurdle that has prevented use of organs from infected patients in research since 1988, the height of the HIV epidemic.
The policy, which goes into effect June 8, means kidneys and livers from donors infected with the human immunodeficiency virus can be collected and transplanted into HIV-infected recipients through specified clinical research studies.
The hope is that by expanding the organ donor list to HIV patients, wait times among those needing organs will be shorter.
A total of 109,706 people in the U.S. were on the waiting list for a kidney, and another 15,775 for a liver, according to the latest estimates from the Organ Procurement and Transplantation Network. Although patients with HIV can receive organs and have a high life-expectancy as a result of advancements in HIV treatments, there was no mechanism through which patients with HIV could become donors.
Use of HIV-positive donor organs for HIV-positive candidates would allow more organs from HIV-negative donors to be used for HIV-negative candidates, explained the United Network for Organ Sharing, the group that holds the federal contract to run the nation's organ procurement program.
The Centers for Disease Control estimates that 1.2 million people in the United States are living with HIV. Up to 30% of those patients have abnormal kidney function, which can lead to kidney failure and require a transplant, according to the HHS. The agency also notes that liver disease that is related to progression of hepatitis B and C is among the leading causes of non-AIDS related death among people living with HIV.
The new rule fulfills a mandate of the HIV Organ Policy Equity, or HOPE, Act, a law signed in 2013 which allowed for research into organ transplants between people already living with HIV.
Next month, members of the UNOS/OPTN board of directors plan to consider an additional set of policies on specific patient-safety measures to assure the organs are only used for HIV-positive candidates.
"Clearly that's everyone's concern, to make sure this is done as safely as possible," says Dr. Dan Kaul, director of the Transplant Infectious Disease Service at the University of Michigan. The discussions, he says, will focus on safeguards regarding the way organs are labeled, a two-step verification process, and algorithms that match HIV-positive organs only to HIV-positive donors, among others.