Kidney transplantation from deceased donors with HIV to recipients with HIV is thus considered as safe as transplantation from donors without HIV by this multicenter observational study conducted in the United States. The clinical results observed appear more consistent with those of smaller pilot studies.
The clinical trial is thus the first to statistically demonstrate non-inferiority,
meaning that the tested approach is “as good” as current standard clinical practice.
Kidney transplants can provide a great survival benefit to people with HIV and end-stage kidney disease, but organ shortages limit access to transplantation. In addition, people with HIV are at higher risk of death while on the waiting list, and as a result their access to transplant is often more limited, than people without HIV.
To address these disparities, the HIV Organ Policy Equity Act (HOPE) was implemented in the United States in 2015 and legalized transplants between donors and recipients suffering from HIV. However, currently the HOPE Act limits this practice to research settings in order to carefully evaluate results. Among the main criteria monitored are post-transplant survival, post-transplant renal function and kidney rejection. Possible risks associated with this practice are also monitored, including the acquisition of a second strain of HIV genetically distinct from the donor which could affect the recipient’s HIV disease.
The study is conducted among 198 adults with HIV and end-stage kidney disease who received kidney transplants in 26 centers and 99 of whom had people living with HIV as donors. The transplants were carried out between April 2018 and September 2021 and the recipients were then followed for 3 years. The analysis reveals that:
- the results in terms of overall survival, graft survival and rejection events are similar between the 2 groups;
- 1 year after the transplant, recipient survival reached 94% in the intervention group, vs. 95% in the controls;
- at 3 years, survival rates remain comparable.
- 1 year after transplantation, the incidence of rejection was 13% in patients in the intervention group vs. 21% in control patients;
- Only 1 case of a recipient “who could have acquired a second genetically distinct strain of HIV” is recorded.
Taken together, these results confirm that kidney transplantation between HIV-infected donors and recipients is safe and not inferior to transplantation from uninfected donors.
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