Johns Hopkins ready to begin organ transplants between HIV-positive donors, recipients

The slow approval process for green-lighting HIV-positive organ transplants has finally reached its end for Johns Hopkins University. The institution is prepared to be the first in the U.S. to perform an HIV-positive kidney transplant, and the first ever to do such a liver transplant.

HOPE for patients

The whole process started with the HIV Organ Policy Equity Act (HOPE Act) (P.L. 113-51), signed into law in 2013. This law directed HHS and the Organ Procurement and Transplantation Network (OPTN) to establish standards involving HIV-positive organ transplants. Prior to this act, the use of HIV-positive organs in transplants was a federal crime.

The HOPE Act was created after South Africa began pursuing HIV-positive to HIV-positive organ donation and experienced success. A 2012 article in the South African Medical Journal emphasized that emerging economies were not able to provide dialysis to all patients who needed it, and noted that the availability of deceased donor organs at a major South African hospital had decreased by half over the most previous decade. The authors, one a transplant surgeon and the other a specialist in HIV medicine, found that HIV-positive donor kidney transplants for HIV-infected recipients was a viable alternative to dialysis or seeking organs from donors who were not HIV-positive.

The authors responded to concerns that donor kidneys could infect the patients with a slightly different strain of the virus by noting that highly active antiretroviral therapy (HAART) is effective at suppressing all clades of HIV. They agreed that drug-resistance rates would inevitably increase, and that there was a concern about transmission of a drug-resistant virus. However, they noted that they would eventually use donor virus genotyping in an effort to suppress resistant viruses.

National Institutes of Health criteria

Following the passage of the HOPE Act, HHS published safeguards and criteria developed by the National institutes of Health (NIH) (Notice80 FR 73785, November 25, 2015). The criteria established that these transplants must be done under institutional review board (IRB)-approved protocol, and must comply with regulations governing human research. The hospital transplant team must have HIV program expertise, experience with HIV-negative to HIV-positive organ transplants, and standard operating procedures and training for handling HIV-positive patients, organs, and tissues. All HIV-positive deceased donors must show no evidence of invasive opportunistic complications of HIV infection, and a pre-implant donor organ biopsy must be completed. If an HIV-positive living donor wishes to participate, the HIV infection must be well-controlled (as further defined in the criteria). The criteria also specifies certain aspects for the required health status for all donors, as well as wait list candidates.

Despite commenter concerns that living donors infected with HIV would be at a higher risk for renal and/or liver disease, HHS noted that the decision should be left up to the living donor/recipient pair following a “rigorous, transparent education and informed consent process.” HHS also identified various questions that could be addressed through future research, such as HIV superinfection, incidence of opportunistic infections, reasons for increased rates of kidney rejection, and outcomes of living donors.

Johns Hopkins

Johns Hopkins is ready to begin finding answers to these questions. An associate professor of surgery at the Johns Hopkins School of Medicine estimated that about 500-600 HIV-positive organ donors could save over 1,000 lives each year. The impact of the implementation of the HOPE Act is significant for many HIV-positive patients, as increased organ availability decreases the likelihood that they will die while on the waiting list or become too sick to survive a transplant. CNN reports that 121,000 patients were on a transplant list in 2014, and only one in four received a needed organ.