Kidney transplantation between HIV-positive donors and HIV-positive recipients is not dangerous

Media Advisory

Wednesday October 16, 2024

The NIH-funded study provides information on transplantation practices currently performed only in research settings.

Transmission electron microscope of HIV-1 particles.

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In a large observational study conducted in the United States, kidney transplants from deceased HIV-positive donors to HIV R+ recipients were safe and similar to transplants from HIV D- donors. This study was funded by the National Institutes of Health and compared clinical outcomes to smaller pilot studies. However, this clinical trial, a statistically powered clinical trial, is the first to demonstrate noninferiority. Noninferiority means that an experimental approach can be as effective as current clinical practice. The results were published in today's issue of New England Journal of Medicine.

A kidney transplant can provide survival benefits to HIV-positive patients with end-stage kidney disease. However, a shortage of organs limits access. People with HIV are at higher risk of dying while waiting for an organ and have less access to transplants. In 2015, to help reduce these disparities, the HIV Organ Policy Equity Act was passed. This law legalized transplants from HIV-positive donors and recipients. Currently, this is only allowed in research settings to assess outcomes. The HOPE Act currently limits this practice to research settings in order to carefully assess outcomes. Researchers have also assessed the unique risks associated with this procedure, including the possibility of acquiring an additional, genetically different strain of HIV that could impact HIV disease in the recipient.

In the current study, 198 adult patients with HIV who were in end-stage kidney failure received kidney transplants at 26 different centers. The study evaluated 99 participants with HIV-positive donors versus 99 with HIV-negative donors. Transplants took place between April 2018 and September 2021, and recipients were followed for approximately three years.

The two groups had similar outcomes in terms of overall survival, graft success, and rejection events. During the first year after transplantation, 94 % of HIV D+/R+ recipients survived and 95 % of HIV D-/R+ recipients. Three years later, the recipient survival rate was 85 % for HIV D+/R+ versus 87 % for HIV D-/R+. Graft survival rates were 93 % for HIV D+/R+ at one year and 90 % for HIV D-/R+. Three years after transplantation, graft survival rates for HIV D+/R+ were 84 % and 80 % for HIV D-/R+. One year after transplantation, the rejection rate was 13 % for HIV D+/R+ and 21 % for HIV D+/R+. And at three years, it was 13 % for HIV D+/R+ and 21 % for HIV D+/R+. Rates of cancer, serious adverse events, and surgical site infection were comparable in the two groups. A recipient may have received a genetically different strain of HIV from the donor. However, there were no clinical consequences.

The results indicate that kidney transplantation between HIV-positive donors and HIV-positive recipients is safe and not inferior to that from HIV-negative donors. These results, according to the authors of this study, provide evidence that supports the expansion of kidney transplantation outside of research settings.

The Johns Hopkins University School of Medicine in Baltimore led the study, which was funded by the NIH's National Institute of Allergy and Infectious Diseases.

Please visit ClinicalTrials.gov and enter the study ID to learn more about this study. NCT03500315.

ARTICLE :
Durand The et all. The HOPE Act: Safety of Kidney Transplantation from Donors with HIV NEJM. DOI: 10.1056/NEJMoa2403733 (2024).

WHO:
Andrew Redd Ph.D. Chief, International Virology Unit, Immunoregulation Laboratory at the National Institute of Allergy and Infectious Diseases.

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The National Institutes of Health: The NIH is the medical research agency of the U.S. Department of Health and Human Services. It is comprised of 27 institutes and centers. The NIH, the nation's medical research agency, is comprised of 27 institutes and centers and is part of the U.S. Department of Health and Human Services. Visit the NIH for more information about its programs and services. www.nih.gov.

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