Kidney transplantation from donors with HIV appeared to be noninferior to donors without HIV in terms of safety for recipients with HIV, an observational study indicated.

Among 198 patients with HIV who received a kidney from a deceased donor, risk of a safety event within a median of 2.2 years was similar between the two groups (adjusted HR 1.00, 95% CI 0.73-1.38), reported Christine Durand, MD, medical director of the Transplant Research Center at Johns Hopkins Medicine in Baltimore, and colleagues.

A safety event was defined as a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection, they noted in the New England Journal of Medicine.

Secondary outcomes and adverse events were also similar between the two transplant groups.

“As someone who cares for people with HIV and sees firsthand the achievements we’ve made in treatment, I was not personally surprised by our finding that kidney transplants from donors with HIV to recipients with HIV were as safe and effective as those from donors without HIV, but I suspect that many people may be surprised, because fear and misperceptions about HIV remain,” Durand told MedPage Today, adding that she hopes these findings “counter any remaining doubts about the safety of this practice.”

Up until the HIV Organ Policy Equity (HOPE) Act was signed into law by President Obama in 2013, there was a federal ban on transplantation from donors with HIV to recipients with HIV. The procedure is now allowed for research purposes only.

In an accompanying editorial, Elmi Muller, MD, PhD, MBA, of Stellenbosch University in South Africa, noted that this practice may soon move beyond the confines of a research setting.

“We can now take procedures that were previously experimental and implement them as standard of care,” wrote Muller. “These results will have far-reaching effects in many countries that do not perform transplantations with these organs.”

Durand noted that the Biden administration recently proposed a rule that would remove clinical research and institutional review board requirements for transplanting kidneys and livers from donors with HIV to recipients with HIV.

“If that rule is approved, the benefits of this practice will become more accessible across the country and more lives will be saved,” she said.

“HIV-to-HIV transplantation is safe and saves lives,” she added. “It provides a benefit for people with HIV and that’s important because currently people with HIV face a higher risk of death on dialysis and face inequities in access to transplant.”

The practice also benefits people without HIV who are on the kidney transplant waiting list, Durand pointed out. “When there are more organs available for transplant, everyone has a better chance of moving up on the list.”

For this study, Durand and colleagues included adults from 26 transplantation centers across the U.S. All had HIV, end-stage renal disease, and met local criteria for kidney transplantation and consented to consider receiving a kidney from a deceased donor with HIV. They also had to have a CD4+ cell count of at least 200 cells/μL, be taking active antiretroviral therapy, and have an HIV RNA level of less than 50 copies/mL. Those with an active opportunistic infection, previous progressive multifocal leukoencephalopathy, and central nervous system lymphoma were excluded.

Donor characteristics were generally similar between the two groups, but donors with HIV were more often Black, had a lower median Kidney Donor Profile Index score, and were more often seropositive for hepatitis B and cytomegalovirus compared with donors without HIV.

Looking at secondary outcomes, there were no significant differences between the patients who had donors with and without HIV for:

• Overall survival at 1 year (94% vs 95%) and at 3 years (85% vs 87%)
• Survival without graft loss at 1 year (93% vs 90%) and 3 years (84% vs 81%)
• Rejection at 1 year (13% vs 21%) and 3 years (21% vs 24%)

The incidence of serious adverse events, infections, surgical or vascular complications, and cancer was also similar between the groups. However, the incidence of HIV breakthrough infection was significantly higher among recipients of kidneys from donors with HIV (incidence rate ratio 3.14, 95% CI 1.02-9.63). The most common reason for HIV breakthrough infection was nonadherence to antiretroviral therapy.

There was also one potential HIV superinfection reported in the group who had donors with HIV. This is a rare event associated with HIV-to-HIV kidney transplant, which could contribute to HIV breakthrough infection or persistent failure of HIV treatment. No cases of persistent HIV treatment failure occurred in this study.

While the observational nature of the study was a limitation, the researchers emphasized that all patients were equally eligible for a kidney from a donor with or without HIV.

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