ATLANTA – As a result of a three-year multicenter clinical trial, researchers at Emory University and Emory Transplant Center have successfully transplanted kidneys from deceased donors infected with human immunodeficiency virus (HIV) into recipients living with HIV. was found to be safe. new kidney. Additionally, researchers have learned that such HIV-to-HIV kidney transplants are just as effective as transplanting a donor kidney without HIV into a recipient living with HIV.
The results of this observational study, funded by the National Institutes of Health (NIH) and led by researchers at Johns Hopkins University School of Medicine. New England Medical Journal October 16th.
In the Hope in Action Phase II clinical trial, which ran from 2018 to 2021, 198 recipients living with HIV received kidney transplants from deceased donors at one of 26 transplant centers in the United States. I received it. Of these, 99 people received kidneys from people infected with HIV. Ninety-nine people received a kidney from an HIV-uninfected donor.
Researchers found that recipients who received kidneys from donors who were infected with HIV had similar outcomes as recipients who received kidneys from donors who did not have HIV. did.
“Multiple studies have shown that people living with HIV face disproportionately many barriers to receiving a transplant,” said Dr. Mitchell, associate professor in the Division of Infectious Diseases at Emory University School of Medicine and director of Hope in Medicine. said Dr. Rachel Friedman Moraco, who is also the site's principal investigator. Action Clinical Trials at Emory.
“This study shows that we can safely expand the donor pool and improve equity for people with HIV who need kidney transplants. And we hope this study will help reduce the stigma surrounding HIV. We would like to thank the donors and their families for willingly allowing us to donate these life-saving organs, and the recipients for willingly participating in this research.” say.
The study found that kidneys from HIV-infected donors were “noninferior,” or not as bad, as those from donors without HIV.
Furthermore, overall survival between the two groups was significantly lower at 1 year post-transplant (94% for HIV-infected donor kidneys and 95% for HIV-uninfected donor kidneys) and at 3 years post-transplant (85% for HIV-infected donor kidneys and 95% for HIV-infected donor kidneys). 85% of kidneys and 95% of HIV-uninfected donor kidneys). 87% for donor kidneys without HIV). Organ rejection rates at 3 years were also similar (21% for HIV-infected donor kidneys and 24% for non-HIV donor kidneys). The incidence of serious adverse events, infections, or surgical complications was also similar between the two groups.
According to the Organ Procurement and Transplant Network, more than 90,000 people are currently waiting for a kidney transplant. That's why studies like the “Hope in Action” clinical trial are so important, experts say.
In 2013, due to a shortage of domestic organ donors, the U.S. Congress passed the HIV Organ Policy Equity Act (HOPE) Act, which allows HIV-infected kidney and liver donors to safely donate their kidneys and livers to recipients living with HIV. They called for a study to find out whether this is possible.
Emory Transplant Center participated in the Hope in Action pilot trial and performed the first kidney transplant in Georgia in 2017 from a deceased HIV-infected donor to a recipient living with HIV.
“Based on research at the Emory facility and 25 other transplant centers in the United States through Hope in Action, the U.S. Department of Health and Human Services is amending current regulations to ensure that kidney and liver transfers from HIV-infected donors to recipients are prohibited. We hope to remove the research requirement for transplants,” said Stephanie Porch, MD, director of Transplant Infectious Diseases at Emory Healthcare and associate professor of medicine in the Division of Infectious Diseases at Emory University.
“This policy change recognizes the incredible work of our research teams and our donors who have sought to push the boundaries to save lives, while contributing to improving equity and access to transplants for people living with HIV.” “It's a testament to the generosity of the donor family,” Porch said.
These new policy updates may not become effective until 15 months after publication of the final policy rule. People living with HIV can continue to enroll in the continuation phase of the Hope in Action trial, which is being conducted at multiple centers.
“People living with HIV and suffering from organ failure of any kind may receive a transplant from an HIV-uninfected donor outside of research studies and may be referred for organ transplant evaluation. It is also important to note that
“The results of the Hope in Action study are an example of how high-quality clinical research can improve care and access for patients in need of transplantation,” said Renal Transplant Surgeon and Executive Director of the Emory Transplant Center. says Thomas Pearson, M.D., Ph.D. . “There is a large disconnect between the supply and demand of donor kidneys in the United States, so these findings will help increase the availability of donor organs for these specific populations and for all patients with end-stage kidney disease,” Pearson said. He is also the Livingston Professor of Surgery at Emory School of Medicine.
As for donating other organs, such as hearts and lungs, from HIV-infected donors to HIV-infected recipients, experts say more research is needed in these areas.
Funding for this research was provided by the following NIH grants: R01AI120938, R01DK131926, U01AI134591, U01AI138897, U01AI177211, and R01DK101677.
