People with HIV are now living healthier, longer lives thanks to advances in antiretroviral therapy, but they can still have chronic diseases like diabetes and hypertension. Eventually, they might need organ replacements, like kidneys, but this group of people has been at a disadvantage.
Patients with HIV have been known to receive lower priority on waitlists given the shortage of organs and misconceptions about the patients’ ability to receive them. But what if we could increase the pool of available organs by allowing the use of organs from donors with HIV for recipients with HIV?
A new milestone was achieved in a first-of-its-kind study in the United States in which Mount Sinai was a major player. The HOPE study, published in The New England Journal of Medicine, showed that not only are kidney transplants from HIV+ donors safe and effective, they are just as much so as transplants from HIV- donors.
“It had been illegal, by federal law, to use HIV+ organs,” says Sander Florman, MD, Director of the Recanati/Miller Transplantation Institute at Mount Sinai and an author of the paper. “Prior to the HOPE Act signed by then-President Obama, organs with HIV had to be discarded. But if we can show it is safe to use organs from people with HIV, why not use them, so that HIV+ people can get transplanted quicker?”
“Eventually, the goal of this study is to move HIV-to-HIV kidney transplants out of just research and into a standard of care,” says Meenakshi Rana, MD, Associate Professor of Medicine (Infectious Diseases) and an author of the paper. “This has larger implications not just for people with HIV, but for everyone who’s on a waitlist—if a person with HIV can receive an organ faster from a donor with HIV, then everyone on the list also moves up.”
Drs. Florman and Rana discuss the importance of the HOPE study, how it could destigmatize organ transplants for people with HIV, and future impacts.
What’s the history of organ transplantation for people who are HIV+?
In the past, people with HIV were considered not medically suitable for organ transplants. It was thought that the immune-suppressing drugs required to prevent organ rejection might cause the HIV to develop into AIDS, says Dr. Florman.
In the late 1990s, Mount Sinai showed that it was possible to do a living liver donation to a patient with HIV. “It was extremely controversial,” says Dr. Florman. “At the time, nobody was doing HIV transplants. And second of all, very few centers in the country were doing living-donor liver transplants.”
Sandy Florman, MD, Director of the Recanati/Miller Transplantation Institute at Mount Sinai (left) and Meenakshi Rana, MD, Associate Professor of Medicine, Infectious Diseases (right).
What is the current law on use of organs from donors with HIV?
In regulations dating to 1988, it was made illegal to transplant or even study organs from donors with HIV. In 2013, President Obama signed the HIV Organ Policy Equity (HOPE) Act, which lifted the research ban.
On November 26, 2024, the U.S. Department of Health and Human Services announced a final rule stating kidney and liver transplants involving donors and recipients with HIV no longer need to be done under the auspices of a clinical trial. The decision was motivated by evidence from studies enabled by the HOPE Act that showed such procedures were safe and effective.
In the 2000s, Mount Sinai participated in another trial that showed it was possible to transplant kidneys from donors without HIV to recipients with HIV—a trial that was the predecessor to the HOPE study.
However, people with HIV faced more than just medical skepticism—they also faced social stigma.
What does having an undetectable HIV load mean?
Having an undetectable load, or simply being undetectable, means HIV levels in a person are so low that they cannot transmit the virus to another person sexually. This is typically achieved through antiretroviral therapy.
“Even with the advent of the medications, where your HIV can be well controlled and you could live a normal life, there is stigma among some medical professionals about getting a needlestick or getting splashed in the eye with blood,” says Dr. Florman. “The reality is that part of the criteria for doing these transplants is that the candidates need to have well-controlled HIV, even undetectable viral load. And so the risk of getting HIV from a needlestick or a splash is actually very low, although not zero.”
What were the HOPE study results?
The HOPE study transplanted 198 kidneys into recipients with HIV. Half of those kidneys were from donors with HIV and the other half from donors without. Mount Sinai was the largest enroller of the trial, transplanting 55 patients.
- There was no significant difference in outcomes between both groups, including overall survival at one year and three years, survival without graft loss at one year and three years, and rejection at one year.
- Adverse events, infections, and complications were similar between both groups, and any HIV-related infection events were able to be treated.
What impacts could this study have?
“Even though we’ve had previous findings that people with HIV could receive transplants, historically, people with HIV have had longer wait times in terms of access to an organ, and higher mortality rates,” says Dr. Rana. “So one of the huge implications of this study is that it could really reduce the wait time of access to organ transplantation for people with HIV, and that’s really important for reducing disparities in transplant.”
That goal is one step closer to becoming reality. On November 26, 2024, the U.S. Department of Health and Human Services announced a final rule stating that after a decade of studies enabled by the HOPE Act, kidney and liver transplants between donors and recipients with HIV are now permitted, and no longer have to be done as clinical trials.
This announcement will hopefully encourage organ procurement organizations (OPOs) to be more inclusive of donors with HIV. “Some OPOs have been good and pursued donors with HIV. Others have not been interested for a variety of reasons. Hopefully, as more HIV patients are able to access transplants, these OPOs would follow the demand and seek more donors with HIV,” says Dr. Florman.
Additionally, the study could expand awareness among patients with HIV and providers that access to life-saving transplantation is more a possibility than ever, says Dr. Rana.
Does this mean people with HIV should consider becoming donors?
“I would definitely want to encourage people with HIV to become donors,” says Dr. Rana. “This would help destigmatize what it means to be a person living with HIV.”
“The patients we helped transplant have always been very grateful, especially because other centers often wouldn’t offer them the procedure,” says Dr. Florman. “But I was surprised that people with HIV who don’t need transplants are grateful that they can now be organ donors. Because now they feel a sense of pride in the idea that they, too, can be organ donors and help save other lives.”