HIV-Positive Donors Safe for Kidney Transplants

Kidney transplant recipients with HIV who receive organs from HIV-positive donors show no worse safety outcomes compared with those receiving organs from donors without HIV, supporting a proposed change to allow such transplants beyond the current restrictions of research-only settings.

“These results will have far-reaching effects in many countries that do not perform transplantations with these organs and will create an opportunity for patients living with HIV to become organ donors, while alive or after death,” reported the authors of an editorial published along with the study, published this week in The New England Journal of Medicine.

“Above all, we have taken yet another step toward fairness and equality for persons living with HIV.”

In the observational study of 198 kidney transplant recipients with HIV, half (99) received a kidney from a deceased donor who was HIV-positive, and the other half from a deceased donor who didn’t have HIV.

For the primary outcome, a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection, the adjusted hazard ratio was an even 1.00, representing non-inferiority, with no significant differences in the composite outcomes between the groups based on the donor’s HIV status.

The findings are particularly important considering the heightened risk that people with HIV have when awaiting kidneys for transplant, first author Christine Durand, MD, an associate professor of medicine and oncology and member of the Johns Hopkins Kimmel Cancer Center in Baltimore, told Medscape Medical News.

“The organ shortage is a public health crisis; every day, nearly 20 people die while waiting for an organ; [however], people with HIV are even more likely to die while waiting, due to higher risk of death on the wait list and lower access to transplant.”

Transplantation of organs from donors with HIV to recipients with HIV was previously banned until 2013, when the HIV Organ Policy Equity (HOPE) Act was passed, making such transplants legal — but only research, not clinical practice.

To further investigate the issue, Durand and her colleagues conducted the current study, which included patients from 26 centers in the United States between April 2018 and September 2021.

The characteristics between the donors who did and did not have HIV were similar, with the exception that donors with HIV were more commonly Black, had a lower median Kidney Donor Profile Index score, and were more often seropositive for hepatitis B and cytomegalovirus than donors without HIV.

In addition to the non-inferior primary outcome observed, secondary outcomes were also similar regardless of whether the donor had HIV, including overall survival at 1 year (94% vs 95%) and 3 years (85% vs 87%), survival without graft loss at 1 year (93% vs 90%) and 3 years (84% vs 81%), and rejection at 1 year (13% vs 21%) and 3 years (21% vs 24%).

In terms of safety, there were also no significant differences between the HIV and no-HIV groups in terms of serious adverse events, infections, surgical or vascular complications, and cancer.

Of note, the incidence of HIV breakthrough infection was higher among recipients of kidneys from donors with HIV (incidence rate ratio, 3.14), and there was one potential HIV superinfection among the 58 recipients who had sequence data, with no persistent failures of HIV treatment.

“Most of the HIV breakthroughs were attributed to patients interrupting their HIV treatment,” Durand noted.

“In all cases, the HIV breakthroughs resolved and did not have any clinical impact,” she said.

Furthermore, the potential superinfection was only detected as the result of in-depth studies done in the research lab and did not involve any signs or symptoms in the patient.

“As far as we know, HIV superinfection is very rare and does not seem to have any clinical impact,” Durand added.

“Clinicians can reassure patients that in the cases of breakthrough, there were no clinical effects reported by study participants or providers.”

In light of the current findings and other studies, the Health and Human Services (HHS) secretary recently proposed a rule to remove the research requirement to perform kidney and liver transplants from donors with HIV to recipients with HIV.

Based on the authors’ previous research of patients involved in the HOPE Act studies, the change cannot come soon enough.

In a 2023 study, the authors found that the wait time for a HOPE Act kidney (from a donor with HIV) was only 10.8 months compared with as much as 60.8 months for a non-HOPE Act transplant — a 3.3-fold higher rate of kidney transplant, Durand said.

“Allowing transplant centers to do these transplants as clinical care, outside of HOPE Act studies, will broaden the impact of this life-saving therapy,” she said.

Only about 30 centers currently offer HOPE Act transplants, while there are more than 250 transplant centers in the United States, Durand noted.

“Limited participation is likely due in part to the administrative infrastructure, time, and effort required to do research,” she said. “Allowing [the HIV donor transplants] as clinical care will remove barriers.”

Further commenting on the research, the editorial author Elmi Muller, MD, PhD, of the Department of Surgery, Stellenbosch University, Stellenbosch, South Africa, noted that a key factor in the favorable results is that newer drug regimens have advanced to better prevent rejection.

“Rejection rates are lower with newer-generation HIV drugs, which have minimal interactions with immunosuppressive drugs than with earlier HIV drugs,” Muller explained.

“Taken together, these outcomes support the expansion of kidney transplantation involving donors and recipients with HIV from research to clinical care.” Muller said.

“The safety of organs from HIV-positive donors is no longer in question; these organs result in excellent graft survival.”

Furthermore, “the introduction of a second viral strain has no clinically significant effect, as shown in the [current] study and in a previous study.”

Durand’s disclosures are detailed in the published study. Muller had no disclosures to report.