Kidney Transplants Between Donors and Recipients with HIV is Safe; Study

By: Ranier Simons, ADAP Blog Guest Contributor

Every eight minutes, a person is added to the U.S. organ transplant waiting list.[1] Although names are added and removed daily, as of October 21st, there are 104,360 candidates on the list.[2] Daily, around seventeen people die waiting for an organ.[1] The organ transplantation landscape for people who are HIV-positive is more dire because they face a higher likelihood of dying while on the waitlist in addition to lesser access to transplants than those living without HIV.[3] This is why the resulting conclusion of a study published last week in The New England Journal of Medicine is promising news. The study data proved that kidney transplantation between donors and recipients with HIV is safe.[4]

Photo Source: The Bioethics Project

Prior to 2013, using organs from HIV-positive donors was prohibited, even If the recipient was also living with HIV. In November of 2013, the HIV Organ Policy Equity Act (HOPE Act) was passed. Its implementation began in November of 2015.[5] The HOPE Act allowed the utilization of organs from HIV-positive donors for transplantation into HIV-positive recipients for research purposes. The goal was to gather data on the safety, efficacy, and feasibility of those transplants. These types of transplants are only allowed at approved facilities observing specific research protocols developed by the National Institutes of Health (NIH).[5] The guidelines specify clinical and safety guidelines as well as study team experience and facility prerequisites.[5] The initial 2015 policy permitted kidney and liver transplants, and in 2020, it was updated to allow the utilization of all organs.

As of November 2022, 358 organs have been successfully transplanted under the HOPE Act. The organs were retrieved from a mixture of live and deceased donors. The recent study published in The New England Journal of Medicine, led by Dr. Christine Durand, is significant because it is the first of its kind to statistically prove that kidney transplantation from HIV-positive donors to HIV-positive recipients is non-inferior to transplantation from donors without HIV.[4] A non-inferior study aims to prove that one treatment is just as good as another and is not worse than what it is being compared to by a pre-determined amount. 

The study is an observational study of 198 candidates where 99 people received a kidney from an HIV-positive donor and 99 received one from a donor without HIV.[4] Its purpose was to measure the non-inferiority of the transplants as well as the risks of HIV breakthrough infection, HIV superinfection, and post-transplantation complications.[4] The primary outcome measure was a safety event 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.[4] The primary outcome is the one investigators of a study consider the most important to measure. The adjusted hazard ratio for the composite primary outcome was 1.00.[4] The adjusted hazard ratio is a measure of the frequency of an event occurrence in one group compared to another. An adjusted hazard ratio of 1.00 means that occurrences or risks are the same. 

Other secondary outcomes were also similar. Regardless of the HIV status of the donor, overall survival at one year was 94% vs. 95%, survival at 3 years was 85% vs. 87%, and survival without graft loss after one year was 93% vs. 90%.[4] HIV breakthrough infection was higher among the recipients of organs from HIV-positive donors. However, that outcome was attributed to medication non-adherence and was corrected with proper medication administration. The reversion from undetectable status was not enduring. 

Additionally, organ rejection rates are lower with more modern HIV antiretroviral medications. They have fewer adverse interactions with transplantation-required immunosuppressive drugs than older HIV medications. Previous positive outcomes from studies in South Africa were the evidence used to support the idea of kidney transplantation between HIV-positive donors and recipients as a viable option. HIV-positive patients on dialysis have a higher risk of death and less access to kidney transplantation. Due to health conditions, HIV-positive patients waiting for kidneys have lower odds of remaining active on the waiting list as well as a lower likelihood of living donor kidney transplantation.[6]

The Durand study supports expanding the availability of these types of transplants. Dr. Durand states, “allowing transplant centers to do these transplants as clinical care, outside of HOPE Act studies, will broaden the impact of this life-saving therapy.”[7] Presently, there are about 30 centers that allow HOPE Act transplants compared to a total of over 250 transplant centers nationwide.[7] Furthermore, a 2023 study showed that the wait time for an HIV-positive kidney was 10.8 months compared to 60.8 months for a non-HOPE Act transplant.[8]

Photo Source: Clinical Advisor

Based on research such as this study, the Biden Administration proposed a new rule in September 2024, entitled: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act.[9] The proposed rule, if approved, will expand the number of centers eligible to offer transplantation between HIV-positive donors and recipients. It removes the clinical research and institutional review board requirements currently under the HOPE Act, specifically for kidney and liver transplants.[9] This is because those two organs are the only two with an abundance of data supporting their usage. The NIH also plans to put together a group to study the criteria for other organs under the HOPE Act with the goal of strengthening data on the utilization of other organs besides kidneys and livers. HHS stated in their press release that “HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV.”[9]

People living with HIV/AIDS face multiple barriers to achieving health equity. In synergy with evidence-based policy responses such as the Biden-Harris proposed rule change, studies such as these are steps towards judicious improvements of the status quo. Increasing the availability of organs from HIV-positive donors not only increases the available organ pool for HIV-positive candidates but potentially increases the availability of organs for transplant candidates without HIV from donors who are not HIV-positive.

[1] Health Resources and Services Administration. (2024, October). Organ Donation Statistics. Retrieved from https://www.organdonor.gov/learn/organ-donation-statistics 

[2] Organ Procurement and Transplantation Network. (2024, October 21). National Data. Retrieved from https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/#

[3] National Institutes of Health. (2024, October 16). Kidney transplantation between donors and recipients with HIV is safe. Retrieved from https://www.nih.gov/news-events/news-releases/kidney-transplantation-between-donors-recipients-hiv-safe#:~:text=Kidney%20transplants%20offer%20a%20survival,transplants%20than%20people%20without%20HIV.

[4] Durand, C. M., Massie, A., Florman, S., Liang, T., Rana, M. M., Friedman-Moraco, R., Gilbert, A., Stock, P., Mehta, S. A., Mehta, S., Stosor, V., Pereira, M. R., Morris, M. I., Hand, J., Aslam, S., Malinis, M., Haidar, G., Small, C. B., Santos, C. A. Q., … Segev, D. L. (2024). Safety of kidney transplantation from donors with HIV. New England Journal of Medicine, 391(15), 1390–1401. https://doi.org/10.1056/nejmoa2403733

[5] Organ Procurement and Transplantation Network. (2020, April). HOPE Act. Retrieved from https://optn.transplant.hrsa.gov/professionals/by-topic/hope-act/

[6] Locke, J. E., Mehta, S., Sawinski, D., Gustafson, S., Shelton, B. A., Reed, R. D., MacLennan, P., Bolch, C., Durand, C., Massie, A., Mannon, R. B., Gaston, R., Saag, M., Overton, T., & Segev, D. L. (2017). Access to Kidney Transplantation among HIV-Infected Waitlist Candidates. Clinical Journal of the American Society of Nephrology: CJASN, 12(3), 467–475. https://doi.org/10.2215/CJN.07460716

[7] Melville, N. (2024, October 17). HIV-Positive Donors Safe for Kidney Transplants. Retrieved from https://www.medscape.com/viewarticle/hiv-positive-donors-safe-kidney-transplants-2024a1000izf?form=fpf

[8] Motter, J. D., Hussain, S., Brown, D. M., Florman, S., Rana, M. M., Friedman-Moraco, R., Gilbert, A. J., Stock, P., Mehta, S., Mehta, S. A., Stosor, V., Elias, N., Pereira, M. R., Haidar, G., Malinis, M., Morris, M. I., Hand, J., Aslam, S., Schaenman, J. M., . . . Durand, C. M. (2023). Wait time advantage for transplant candidates with HIV who accept kidneys from donors with HIV under the HOPE Act. Transplantation. https://doi.org/10.1097/tp.0000000000004857

[9] U.S. Department of Health and Human Services. (2024, September 12). Biden-Harris Administration Issues Proposed Rule to Expand Access to Life-Saving Organs for People with HIV. Retrieved from https://www.hhs.gov/about/news/2024/09/12/biden-harris-administration-issues-proposed-rule-expand-access-life-saving-organs-people-hiv.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.