Cross-posted from NIAID Now Blog

Organ donation saves lives. Tragically, many patients are waiting for a life-saving transplant, and there are not enough people registering as organ donors. As a result, 20 people die each day waiting for a transplant—including people living with HIV, who are more likely than HIV-negative people to develop end-stage kidney and liver disease. The HOPE Act of 2013 allows for research into organ transplantation from one person with HIV to another, ultimately benefitting all people waiting for transplants by increasing the number of people eligible to become organ donors.

To learn more about how researchers are leveraging this legislation, NIAID Now spoke to two HIV transplantation experts. Beverly Alston-Smith, M.D., serves as the chief of the Complication and Co-infections Research Branch in NIAID’s Division of AIDS, and Jonah Odim, M.D., Ph.D., is chief of the Clinical Transplantation Section in NIAID’s Division of Allergy, Immunology and Transplantation. Both experts oversee organ transplantation studies among people with HIV.

Q: How does the HOPE Act of 2013 change research into organ transplantation for people living with HIV?

JO: The HOPE Act of 2013 was an important milestone in HIV and solid organ transplantation research. This legislation permits transplant teams with an approved research protocol to transplant kidneys and livers from donors with HIV to appropriate candidates with well-controlled HIV and end-stage organ failure. For a person living with HIV who needs a transplant, this means they may not wait as long for a transplant if an organ from a donor with HIV is available. It also means that people with HIV may now sign up to become organ donors and potentially give the gift of life when they pass away.

Q: At the height of the AIDS crisis, people with HIV were not considered good candidates for organ transplantation, and federal law prohibited HIV-exposed organs from being transplanted to anyone in any circumstance. What has changed since then to make the HOPE Act possible?

BAS: The old policies were implemented before HIV could be effectively treated and when organ transplantation itself was not as safe and effective as it is today. Back then, doctors feared people with HIV would not survive an organ transplant because of a weakened immune system. Today, HIV is a chronic condition managed by highly effective medications. People with HIV are living longer and reaching advanced ages where end-stage organ failure is more common. In fact, people with HIV are at a higher risk for kidney and liver disease than their HIV-negative peers because of co-infections like viral hepatitis and long-term damage to organs from HIV itself. On the other hand, because of effective treatment, more people with HIV do seem to have organs healthy enough to be donated to someone in need of one. Successful kidney transplants between people with HIV in other countries such as South Africa also have shown that this practice may be both safe and effective.

Q: The federal Organ Procurement and Transplantation Network (OPTN) estimates that every 10 minutes, someone is added to the national transplant waiting list, and many people die before a potentially life-saving organ becomes available—including many people with HIV. Can the HOPE Act help change this?

JO: That is absolutely the goal. Both people with and without HIV are on organ waiting lists. Because of the HOPE Act, people living with HIV can now also accept organs from donors with HIV who were previously excluded from the organ donor pool.  This also means people without HIV may then move up on the list for an HIV-negative organ if people with HIV receive organs from this new alternative source—thereby shortening waiting times for people regardless of HIV status.

Q: Why do organ transplants between people with HIV need to occur under a research protocol?

BAS: All new medical procedures need to be rigorously tested for safety and efficacy before they are widely implemented, and this is no exception. Since the enactment of the HOPE Act, many transplant centers in the United States are assessing transplant- and HIV-related outcomes after transplantation between people with HIV to establish safety and efficacy for recipients over the long term.

Q: In 2017 and 2018, NIH launched the HOPE in Action studies. What are they, and what do these large-scale trials hope to accomplish?

JO: While there are many ongoing small pilot studies since enactment of the Act, the HOPE in Action Multicenter Kidney Study and the HOPE in Action Multicenter Liver Study are the largest safety and efficacy clinical trials underway, to date, in the United States. As their names imply, these studies are putting the intent and motivation behind the HOPE Act into clinical practice under the oversight of an Internal Review Board, or IRB, and NIH-sponsored clinical research. This oversight gives research participants robust protection as we aim to answer these scientific questions.

The Kidney Study is evaluating the clinical outcomes of 160 transplants of kidneys into people living with HIV and end-stage kidney disease. Each kidney will come from a deceased donor; half of them will come from donors with HIV and the other half from donors without HIV for comparison. In the Liver Study, 80 transplants will occur, in which half of the livers will originate from donors with HIV and half from HIV-negative deceased donors for comparison. Both study teams are chaired by investigators at Johns Hopkins University.  Researchers will follow all recipients for up to four years to monitor the success of the transplant, and the health and quality of life of participants.  In addition, the researchers hope to gain further insight and understanding of HIV strains, antiretroviral therapy, and immunosuppression in the unique context of solid organ transplantation. The results from these studies will determine the safety and efficacy of this practice and may hopefully expand this approach to transplantation centers throughout the country as standard of care.

Q: Will the HOPE in Action studies evaluate interventions beyond assessing the safety and efficacy of transplants of HIV-positive kidneys and livers into people with HIV?

BAS: Yes! This large study will provide a wealth of information on transplants between people with HIV and transplantation science in general. HOPE in Action participants are also eligible to enroll in a study evaluating the use of the antiretroviral drug maraviroc to prevent organ rejection, a finding that may translate to HIV-negative people undergoing organ transplants.

Q: If you are a healthy person with HIV, can you donate your organs to participants in HOPE in Action or similar studies?

JO: The bottom line is that anyone can sign up to become an organ donor regardless of health conditions and HIV status. Ultimately, representatives from a local Organ Procurement Organization (OPO), the transplant hospital teams, and recipients on the waiting list determine whether potential organs, as they become available, are suitable for transplantation in willing and appropriately consented recipients. In fact, all organs from deceased and living donors are routinely screened for HIV, as well as other infections and cancers. So, if you are living with HIV and want your organs to be eligible for donation to others with HIV when you pass away, sign up to become an organ donor.

In a landmark case this March, surgeons at Johns Hopkins University successfully transplanted a kidney from a living donor with well-controlled HIV into a recipient also living with well-controlled HIV. This procedure was performed under a specialized clinical protocol. (Read a related blog post from HIV.gov.)

Q: If you are a person with HIV in need of an organ transplant, how can you enroll in HOPE in Action?

BAS: Participants in HOPE in Action are enrolled when an organ becomes available. However, it is important to note that HOPE in Action participants are not given priority over others on the organ waiting list. If you are living with HIV and currently on an organ waiting list, ask your doctor about participating in HOPE in Action. A list of participating centers is available here, along with further information for clinicians. You can also reach out to the clinical trial team for information on eligibility and learn more about the trial by visiting ClinicalTrials.gov and entering identifiers NCT03500315 (kidney study) or NCT03734393 (liver study).

Learn more about organ donation and sign up to become an organ donor at www.OrganDonor.gov.

Read more about the HOPE in Action Multicenter Kidney Study and the HOPE in Action Multicenter Liver Study.