In June, the Department of Health and Human Services (HHS) and the U.S. Public Health Service (USPHS) published updated organ-transplant guidelines that remove some limitations on who can be considered as a donor. Specifically, the guidelines address donors who were previously considered high risk for having HIV, hepatitis B (HBV), or hepatitis C (HCV). The changes recognize progress in both the tests for and treatment of these viruses, and experts hope that they will lead to more organs being available for transplant and fewer people dying while on waiting lists.
The Organ Procurement and Transplantation Network (OPTN) develops policies for donor selection, organ procurement and allocation, recipient informed consent, and follow-up monitoring. OPTN works with the Centers for Disease Control and Prevention (CDC) to create policies that prevent the spread of infectious disease through the organ-donation process. All organs are tested for HIV, HBV, and HCV before being accepted for transplant, but because of the possibility that a deceased donor could have been in the “window period” between infection and a positive test result, some organs were rejected based on the donor’s behavior.
Under the previous guidelines published in 2013, certain groups were labeled as high social risk, including men who had sex with men (MSM) and women who had sex with MSM. Family members were also asked about the donor’s behavior in the past 12 months, including whether they had had sex in exchange for money or drugs, had injected drugs for non-medical reasons, or had had sex with anyone who had engaged in these behaviors. Donors could also be labeled as high risk for having been incarcerated for over 72 consecutive hours or having an unknown social history in the past 12 months.
Transplant experts argued that testing for these viruses had become so good that it no longer made sense to exclude donors based on their behavior over the past year. Jonah Odim, M.D., Ph.D., who heads the Transplantation Branch at the National Institute of Allergy and Infectious Diseases, told TheBody that improvements in both antibody tests and nucleic acid tests have significantly shortened the window period and mean that we no longer need to rely on “medical, social, and behavioral remote history from third-party family and friends in the middle of the night.”
Dorry Segev, M.D., Ph.D., director of the Epidemiology Research Group in Organ Transplantation at Johns Hopkins University, agreed. He told TheBody in an email that these donors were “never really increased risk, and in fact, often those classified as such were healthier, younger, lower risk donors who might have had a small risk of undetected HIV/HBV/HCV infection.”
The new guidelines remove what Odim called the “tainted high risk label” for donors based on social groups. Instead, they mandate that all donors and recipients be screened with both antibody and nucleic acid testing and require that all recipients be vaccinated for HBV. Donors or their families will still be asked about behavior, but only within the past three months rather the previous year.
The guidelines also change the process by which recipients give informed consent. In the past, recipients of organs from donors who had or were at risk of having any of these viruses had to sign a special consent form, but now all recipients will receive the same education about the potential risks of infection.
New Acceptance of HCV-Positive Donors
Though the bulk of the guidelines deal with procedures for donors who have not tested positive for HIV, HCV, or HBV, the document does include a discussion of using organs from donors with known HCV infection. In the past, these organs would only be used in patients who were already infected with HCV. Now that HCV can be cured with direct-acting antivirals (DAAs), however, more transplant centers are using HCV-positive organs in HCV-negative recipients. The guidelines say that this is safe and effective and suggest that transplant centers should develop a plan for educating potential recipients and getting informed consent in these situations.
Odim explained that the opioid crisis has led to an increase of potential donors who are young and have otherwise healthy organs but have HCV. These organs were being discarded when, in many cases, they were the better or only option for people on the waiting list. He described using HCV-positive organs in recipients who do not have the virus as a “small infusion into a scarce supply.”
Of course, one of the problems is that DAAs remain very expensive. Patients who receive an HCV-positive organ will inevitably become infected and require these drugs, which can cost anywhere from $24,000 to over $90,000. The guidelines recommend that transplant centers work to ensure that recipients don’t have any payment or reimbursement barriers that would delay HCV treatment after their transplant.
No Change to Rules Regarding HIV-Positive Donors
These guidelines do not change the rules about organs from living or deceased donors with HIV, which were established in 2013 through the HIV Organ Policy Equity (HOPE) Act. Until then, it was illegal to use organs from an HIV-positive individual for any kind of transplant. The HOPE Act allowed for transplants from donors with HIV to recipients who also had HIV. Researchers who championed the law, including Segev, argued that it was unethical to waste the opportunity for transplants between HIV-positive individuals and that allowing such transplants would help HIV-negative individuals in need move up the wait list faster as well.
Segev performed the first transplant in the U.S. from a deceased HIV-positive donor in 2016—giving a liver to one recipient and a kidney to another. Since then, there have been numerous other HIV-to-HIV transplants. Last year, Segev and his team performed the first transplant from a living HIV-positive donor when Nina Martinez, who had contracted HIV via a blood transfusion as an infant, offered to give a kidney to an anonymous recipient who also had HIV.
While these guidelines do not change the rules regarding donors with HIV, experts believe that they will help increase the number of HIV-to-HIV transplants because co-infection with the two viruses is so high.
Ultimately, the new guidelines mean that fewer organs will be disqualified. With more than 110,000 patients on waiting lists, experts agree that this is important. Segev said the document addresses many of the issues that the transplant community had with the earlier guidelines and described this as a “good step forward.”
And, Odim added in an email, “Even while the ongoing COVID-19 pandemic hit transplant rates across the country hard, and [they] are now slowly rebounding, the new published PHS guidance document may continue to slowly and safely increase the donor organ supply, reduce organ wastage, and improve the quantity and quality of life for our patients with terminal organ failure committed to the national transplant waiting list.”