media advisory
Wednesday, October 16, 2024
The NIH-funded study provides evidence regarding transplantation practices that are currently limited to research settings.
A U.S. multicenter observational study found that kidney transplants from deceased HIV-infected (HIV D+) donors to HIV-infected (HIV R+) donors are safe and are as safe as kidney transplants from HIV-free donors (HIV D-). It was equivalent. Although the observed clinical outcomes were consistent with small pilot studies, this National Institutes of Health (NIH)-funded clinical trial is the first to statistically detect non-inferiority. , which means that the approach under study is as good as standard clinical practice. The result is today. New England Medical Journal.
Kidney transplants provide survival benefits for patients with HIV and end-stage renal disease, but access is limited due to organ shortages. Additionally, people with HIV have a higher risk of dying while on the organ waiting list and have lower access to transplants than people with HIV. To address these disparities, the HIV Organ Policy Equity Act (HOPE) of 2015 legalized transplants between donors and HIV-infected recipients. Currently, the HOPE Act limits this practice to research settings in order to carefully evaluate the results. These include post-transplant survival, post-transplant renal function (also called graft survival), and kidney rejection. The study also evaluated the potential risks inherent in this practice, such as acquiring a second, genetically distinct strain of HIV from the donor, which could affect the recipient's HIV disease.
The study enrolled 198 adults with HIV and end-stage renal disease who had undergone kidney transplants at 26 sites, including 99 study participants with HIV-infected donors and 99 participants with HIV-uninfected donors. We compared the research results of 99 people with Transplants were completed between April 2018 and September 2021, and recipients were then monitored for approximately three years.
Results regarding overall survival, graft survival, and rejection were similar between the two groups. Recipient survival 1 year after transplantation was 94% for HIV D+/R+ and 95% for HIV D-/R+. Recipient survival at 3 years was 85% for HIV D+/R+ and 87% for HIV D-/R+. One year after transplantation, graft survival was 93% for HIV D+/R+ and 90% for HIV D-/R+. At 3 years post-transplant, graft survival was 84% in HIV D+/R+ and 80% in HIV D-/R+. Finally, at 1 year posttransplant, rejection rates were 13% for HIV D+/R+ and 21% for HIV D-/R+, and at 3 years, 13% for HIV D+/R+ and 21% for HIV D-/R+ . Rates of serious adverse events, surgical site infections, surgical/vascular complications, and cancer were also similar between the two groups. One case of a recipient who may have acquired a second genetically distinct HIV strain from the donor was observed, but there was no appreciable clinical impact.
Overall, our findings indicate that kidney transplants between HIV-infected donors and recipients are safe and noninferior to transplants from donors without HIV. According to the authors, these findings provide evidence to support expanding the practice outside of research settings.
The study was led by Johns Hopkins University School of Medicine in Baltimore and funded by NIH's National Institute of Allergy and Infectious Diseases (NIAID).
For more information about this trial, please visit ClinicalTrials.gov using the study identifier. NCT03500315.
article
Durand others. Safety of kidney transplants from HIV-infected donors under the HOPE Act. NEJM. DOI: 10.1056/NEJMoa2403733 (2024).
who
Dr. Andrew Red, Director, International Virology Unit, National Institute of Allergy and Infectious Diseases, Immunomodulation Laboratory.
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