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In late November, HHS issued a final rule updating transplant regulations to enable every U.S. transplant center to transplant kidneys and livers from donors with HIV into recipients with HIV — this is a milestone to be recognized and celebrated. Previous regulations had restricted such transplants to medical centers with established research protocols, limiting patient access. In tandem with the final HHS rule, NIH issued proposed revisions to remove the strict criteria for other HIV Organ Policy Equity Act (HOPE Act) solid organ transplants, such as heart, hung, and pancreas.
These developments are welcome steps that benefit all patients with advanced organ disease. But much work remains to be done to build systems of care that ensure everyone with HIV who has end-stage organ disease receives the treatment they need. This will require building capacity across specialties and health systems so that all transplant centers are able and willing to offer transplant from a donor with HIV to a recipient with HIV.
Background on Transplantation in People Living With HIV
Modern medication regimens have transformed HIV from a deadly disease into a chronic disease, with some patients now surviving more than 40 years after diagnosis. Most people living with HIV (PLWH) only require one pill per day, or an injection every 2 months, and may only need to see a physician twice annually.
However, PLWH face end stage organ disease at rates several-fold higher than people without HIV. Solid organ transplantation of the heart, liver, lung, or kidney may be the best therapeutic option for a patient with advanced organ disease, but this treatment requires lifelong immunosuppression to avoid rejection of the transplanted organ.
While it may seem dangerous to give powerful immunosuppression to people with a condition known for weakening the immune system, studies in the first two decades of the 2000s showed that PLWH could safely receive kidney and liver transplants. However, the management was highly complex due to the overlapping toxicities of post-transplant immunosuppressive drugs and the HIV medications available at the time. Many centers did not feel they had the expertise to take on the challenge, posing a major barrier to access to transplant for PLWH.
Advances in medication management for HIV and for hepatitis C have greatly simplified post-transplant care for PLWH, removing one barrier to transplant and enabling more centers to offer kidney and liver transplants to PLWH. Over the last decade, several centers launched programs to expand heart and lung transplants from HIV-negative patients to PLWH.
Expanding the Donor Pool
More recently, landmark multicenter trials have demonstrated that liver and kidney transplants from PLWH to other PLWH are safe, and also lead to patients spending significantly less time on the waitlist for an organ. The newly released HHS regulations reflect the results of these studies.
The NIH-proposed relaxation of the criteria for other organ transplants would eliminate a critical roadblock for centers to offer heart, lung, and pancreas transplant under HOPE protocols. Improving access to HOPE transplant benefits all patients, not just those with HIV, by allowing people to move up on waiting lists and decreasing competition for scarce organs.
The Need for Cooperation With Community Providers
PLWH often have complex care needs, and even before requiring a transplant, they must learn to navigate a complicated system. Compounding the barriers to traditional care, additional challenges for PLWH can prevent them from accessing transplant.
Patients must first be referred by a community provider to a transplant center, but who is responsible for this referral is itself an open question. Furthermore, many HIV providers may not know the indications for transplant referral, the process for arranging a transplant evaluation, or even which centers will and will not offer a transplant. Providers in general may also be reluctant to refer patients to a center that has declined a patient with HIV in the past, even if that center’s policy has changed.
Then patients must be able to actually make it to a transplant center. There are major geographic disparities in access to transplant generally, which are only magnified for PLWH given the smaller number of centers currently offering HOPE transplant. While expanding the number of centers offering HOPE transplant will reduce this barrier, we still need to better understand the socioeconomic barriers — like transportation, finances, and psychosocial factors — that prevent patients from even undergoing transplant evaluation.
Finally, transplant centers must have the capacity and willingness to evaluate and list patients with HIV for transplant. A survey our center conducted a decade ago identified numerous barriers transplant centers felt they faced when starting programs for PLWH. Innovations in medicine typically take years to disseminate, but this timeline may be significantly prolonged due to the unique history of HIV and the stigma PLWH often face.
HOPE Is Possible
Since the HOPE regulations were last revised by HHS in 2020, only one center — my own, Montefiore Einstein in the Bronx, New York — had successfully transplanted a heart from a donor with HIV into a recipient with HIV (2022). We were one of the rare centers to meet the previously strict research protocol standards. (To date, no center has accepted a lung or pancreas from a patient with HIV.) After demonstrating that our team had sufficient experience transplanting organs in PLWH under the HOPE protocols, it took us another year of navigating red tape and regulatory requirements before we were permitted to perform an HIV-positive-to-HIV-positive heart transplant. It took only 6 days for our first recipient to get the heart transplant she so desperately needed.
It is a promising step that governing agencies are enabling more transplant centers to provide these lifesaving surgeries. But health systems will need support to ensure they have the proper infrastructure in place, and the capacity to evaluate donors and care for PLWH after transplant.
In order to build this capacity and confidence at our medical center, we held monthly meetings to review donor offers and determine which donors would be appropriate for our patients. Confidence-building is a gradual process. We were fortunate to have partners at other institutions who we could consult at short notice. Our mission now is to transfer the knowledge and capabilities built at our institution to others around the country.
The change in federal regulations is welcome, but much work remains to ensure that the scientific advances enabled through the HOPE Act are available to all PLWH.
Vagish Hemmige, MD, MS, is an infectious disease specialist at Montefiore Einstein in New York City.