Landmark Study Proves Effectiveness of Kidney Transplants from HIV-positive Donors to HIV-positive Recipients
Article Summary
- Results from the HIV Organ Policy Equity (HOPE) study shows kidney transplants from HIV-positive donors to HIV-positive recipients are just as safe and effective as those from HIV-negative donors.
- The HOPE study has examined the risks and benefits of using kidneys from HIV-positive donors for HIV-positive recipients for more than 10 years.
- Dr. Michele Morris says the study will expand the pool of potential donors for both HIV-positive and HIV-negative transplant candidates.
Patients living with HIV and in need of kidney transplants now have more donor options, as shown by the HIV Organ Policy Equity (HOPE) study.
Published in the New England Journal of Medicine, the research, conducted in collaboration with the University of Miami Miller School of Medicine, demonstrates that kidney transplants from HIV-positive donors to HIV-positive recipients are just as safe and effective as those from HIV-negative donors.
Since its inception in 2013, the HOPE study has examined the risks and benefits of using kidneys from HIV-positive donors for HIV-positive recipients. Michele Morris, M.D., professor in the Division of Infectious Diseases and director of the Immunocompromised Host Section at the Miller School, co-authored the study and emphasized its significance.
“Patients with HIV and end-stage kidney disease are two to three times more likely to die on the transplant waiting list than kidney failure patients without HIV,” Dr. Morris said. “Participants in the HOPE study experienced shorter wait times and higher transplant rates. This study will expand the pool of potential donors for both HIV-positive and HIV-negative transplant candidates by including donor kidneys from HIV-positive patients.”
A New Era in Kidney Transplantation
The need for this research was first identified in South Africa when Elmi Muller, M.D., a transplant surgeon, observed healthy organs being discarded solely because the donors had HIV. Determined to save the lives of HIV-positive patients on dialysis, Dr. Muller led a pilot study involving four kidney transplants using HIV-positive donors and recipients, with successful outcomes.
“The primary concern was the potential transmission of antiretroviral-resistant HIV, as well as hepatitis B and C,” Dr. Morris said. “Organ recipients already require immunosuppressive medications to prevent rejection, so the introduction of additional infectious risks was a critical concern.”
The success of South Africa’s pioneering efforts spurred interest in similar studies in the U.S., culminating in the signing of the HOPE Act during the Obama administration. Dr. Morris saw the importance of the study in South Florida, which has some of the highest HIV infection rates in the nation.
“After years of planning, the Miami Transplant Institute was recognized for its dedication to transplanting HIV-negative organs into HIV-positive recipients and was invited to participate in the HOPE study,” Dr. Morris said. “This project allowed me to focus on expanding access to lifesaving transplants for patients with HIV, a cause close to my heart.”
Ensuring Viable Organs in the HOPE Study
The HOPE study required consent from HIV-positive donors or their next of kin. HOPE donor organ screening included standard screening for infection, malignancy and other conditions that could be transmitted through transplantation. In addition, information about the donor’s HIV treatment history was obtained whenever possible to guide subsequent treatment of the organ recipient. Miami’s Life Alliance Organ Recovery Agency (LAORA) was a leading participant in the HOPE study. LAORA donor organs were transplanted to matched donors in Florida and throughout the U.S.
This study will expand the pool of potential donors for both HIV-positive and HIV-negative transplant candidates by including donor kidneys from HIV-positive patients..
Dr. Michele Morris
Donors fell into three categories: those not in treatment or unaware they were HIV-positive, individuals with false-positive tests and HIV-positive donors in care. On the recipient side, Dr. Morris and HOPE leaders enrolled patients awaiting transplant before an organ offer, conducting pre-research meetings to explain the study, organ source and post-care. Patients were required to meet with independent transplant clinicians, such as social workers or nurses, to ensure voluntary participation.
“Study patients had access to a shorter waiting list and a younger pool of donor organs,” Dr. Morris said. “Recipients were also supported by an experienced health care team that closely monitored their care. Additionally, the HOPE Act mandated that the principal investigator ensure effective HIV treatment was available to manage the donor’s HIV strain in the recipient.”
A New Standard in Transplant Care
Post-transplant care involved intensive follow-up to ensure the success of the procedure. During the first month after surgery, patients were monitored weekly to confirm that the transplanted kidney was functioning properly. Subsequent follow-ups occurred every few months over several years, with attention to any signs of infection or hospital admissions.
“Transplantation is an immunosuppressive procedure, so careful monitoring was essential at all participating centers nationwide,” Dr. Morris said. “Our findings showed that outcomes for recipients of HIV-positive donor kidneys were not inferior to those receiving kidneys from HIV-negative donors.”
Thanks to the success of the HOPE study, the U.S. implemented a groundbreaking rule on November 26, 2024, allowing people with HIV to receive kidney or liver transplants from HIV-positive donors as part of routine clinical practice, no longer limited to research studies. Just over a month later, on December 30, 2024, the U.S. Department of Health and Human Services expanded this rule to simplify the research requirements for transplantation of non-kidney and non-liver HIV-positive donor organs, such as heart, lung, and intestine transplants.
“HIV-positive transplant candidates for heart, lung, intestine, and other organs now have access to both HIV-positive and HIV-negative donor organs under revised research criteria informed by the HOPE study,” Dr. Morris said. “The HOPE study has truly transformed the standard of care for HIV-positive transplant candidates, donors, and recipients.”
Tags: Dr. Michele Morris, HIV, HIV infection, HIV research, kidney transplantation, New England Journal of Medicine