NIH Deems Kidney Transplantation Safe Between HIV-Positive Donors and Recipients

July 29, 2020

HIV-positive individuals with end-stage kidney disease may now have a larger pool of kidneys available to them, with recent study results from the National Institutes of Health (NIH) showing that kidneys from HIV-positive deceased donors can be used in addition to those from HIV-negative donors.

HIV-positive individuals with end-stage kidney disease (ESKD) may now have a larger pool of kidneys available to them, with recent study results from the National Institutes of Health (NIH) showing that kidneys from HIV-positive deceased donors can be used in addition to those from HIV-negative donors, despite theoretical risks that include HIV breakthrough viremia, HIV-associated renal disease, infection, rejection, and malignancy.

The odds of a person with HIV and ESKD dying while on dialysis are 3 times greater compared with HIV-negative individuals who have ESKD.

The HIV Organ Policy Equity Act, or HOPE Act, “allows organ transplants from donors with HIV to recipients with HIV in approved research studies in the United States,” noted the authors who are all part of the HOPE in Action team. “Experts concurred that kidney transplantation between people with HIV would expand the pool of available organs and save lives.”

The act also ensures that these research studies adhere to HHS HOPE Act Safeguards and Research Criteria and that they can continue but only upon review and approval by the current HHS secretary.

Seventy-five virally suppressed HIV-positive adults from 14 clinical research sites were enrolled in the prospective pilot observational study and received 25 HIV-positive donor kidneys and 50 HIV-negative donor kidneys, from 57 donors, between March 2016 and July 2019. Of the recipients in the latter group, 22 of the donors had a prior false-positive HIV test.

All participants were at least 18 years old and on antiretroviral therapy, with CD4 counts of at least 200 cells/mcL and HIV RNA below 50 copies/mL. The median (interquartile [IQR]) CD4 count was 528 cell/mcL (IQR, 348-727). Most (85%) were African American.

The results show a 100% survival rate for all transplants, but those who received HIV-negative kidneys had a 1.8-year follow-up compared with 1.4 years for those who received HIV-positive kidneys. HIV-related complications were rare, and everyone received induction treatment. Hypertension (36%) and HIV-associated renal disease (29%) were the leading causes of kidney disease.

Positive donor status was confirmed by screening for HIV antibodies or antigens and with a qualitative nucleic acid test per the Organ Procurement and Transplantation Network.

The 2 study groups also had excellent overall graft survival at the 1-year mark, as shown by 91% of the HIV-positive—kidney group and 92% (P = .9) of the HIV-negative—kidney group.

“The new findings build on research from 2019, when scientists from the University of Cape Town and NIH reported that people living with HIV who received kidney transplants from deceased donors with HIV had high overall survival and kidney graft survival after 5 years,” the NIH said in a statement about the HOPE in Action team’s findings.

Additional close results were reported between the HIV-positive— and -negative–kidney groups, respectively for the following measures:

  • Estimated glomerular filtration rate: 63 vs 57 ml/min (P = .31)
  • HIV breakthrough: 4% vs 6% (P > .99)
  • Infectious hospitalizations: 28% vs 26% (P = .85)
  • Opportunistic infections: 16% vs 12% (P= .72)

There were instances of rejection in both groups at 1 year, although the authors noted this was not statistically significant. This happened in 50% of the HIV-positive—kidney group and 29% (HR, 1.83; 95% CI, 0.84-3.95; P = .13) of the HIV-negative—kidney group, with induction treatment showing a strong association with rejection.

“Overall patient and graft survival were excellent and comparable, without evidence of increased [serious adverse events] or HIV-related complications such as breakthrough viremia, infectious hospitalizations, or opportunistic infections,” the authors concluded. “This unique donor organ source has the potential to mitigate disparities for a vulnerable population that faces lower access to transplant and higher waitlist mortality.”

They recommend future investigation of transplantation between HIV-positive donors and recipients due to the somewhat high rejection rate their study saw, as well as the immunosuppression considerations for this population.

Reference

Durand CM, Zhang W, Brown D, et al. A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action. Am J Transplant. Published online July 23, 2020. doi:10.1111/ajt.16205