Organ transplants between HIV-positive (HIV+) donors and HIV+ recipients involve special ethical concerns, in addition to those encountered in all transplants, say experts from Johns Hopkins, less than a week after announcing the world’s first HIV+ to HIV+ liver transplant. They outline those ethical concerns in a commentary published in the Annals of Internal Medicine.
Obtaining organs from HIV+ donors was banned in the United States from 1988 until the passage of the HIV Organ Policy Equity (HOPE) Act in 2013. If proved safe in clinical trials, organ transplants between HIV+ individuals could benefit both HIV+ as well as HIV-uninfected recipients, by overall expansion of the donor pool.
“The HOPE Act is appropriately named, addressing current disparities in access and survival for HIV+ patients in need of transplants. Nevertheless, careful consideration of the ethical issues involved is critical to the safe and appropriate evaluation of this novel approach to transplantation,” says Jeremy Sugarman, the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics, senior author of the commentary in Annals.
“We are very thankful to Congress, the president and the entire transplant community for letting us use organs from HIV-positive patients to save lives instead of throwing them away, as we had to do for so many years,” says Dorry Segev, Director of the Epidemiology Research Group in Organ Transplantation at Johns Hopkins Medicine, and of co-author of the commentary with Sugarman and Christine Durand, Assistant Professor of Medicine and Oncology at Johns Hopkins.
In their article the authors caution that, “this historic change brings ethical opportunities and challenges. For HIV+ individuals in need of organ transplant, issues of access, risk, and consent must be considered. For potential HIV+ donors, there are additional ethical challenges of privacy, fairness and the right to donate.”
“As a clinician taking care of patients living with HIV both before and after transplants,” Durand emphasized that, “to do our jobs well it is critical to identify and address these ethical issues as we gain initial experience with HIV+ to HIV+ transplants. We owe it to our patients and society.”
The authors note that the HOPE Act currently limits transplants using HIV+ organs to approved research that follow guidelines set by the National Institutes of Health (NIH) stating, “If data from initial studies are favorable, there should be a commitment to more widespread implementation to ensure fair access to therapies.”
HIV+ individuals face disproportionately higher mortality while awaiting transplants, the commentary explains; kidney disease is common, affecting up to one-third of those infected with HIV. Liver disease is also a leading cause of death in those with HIV infection. Thus, the authors state, alongside the increasing need for organ transplantation among HIV+ patients is an ethical obligation to provide such treatments.
Among the risks of ethical importance highlighted is the increased incidence of immunologic rejection in HIV+ recipients, which is 2-4 times higher than average HIV- recipients, for unknown reasons. In addition, there is a risk of HIV superinfection (infection with a second strain of HIV), and if virus from an HIV+ donor carries drug resistance mutations, it may not be controlled by the recipient’s ART regimen.
Due to the risks and uncertainty of benefits, informed consent that takes into account HIV-specific concerns is essential, the authors state. “In addition to mandated clinical outcomes reporting, social and psychological outcomes should be assessed,” they write in Annals.