1. Among patients living with human immunodeficiency virus (HIV) who received deceased donor kidney transplants, kidneys from donors with HIV were noninferior to donors without HIV in composite safety outcomes.

2. The incidence of HIV breakthrough infection was higher for recipients of kidneys from donors with HIV.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Kidney transplantation is a life-saving intervention for patients with end-stage renal disease. Persons with HIV receiving dialysis have high mortality risks yet less access to transplantation than those without HIV. Organ transplantation from donors with HIV was banned before new legislation and research recommendations emerged. Early observational evidence, albeit limited, showed promising outcomes in kidney transplantations from HIV-positive donors to HIV-positive recipients. This was an observational study comparing the transplantation of kidneys from deceased donors with HIV and without HIV to recipients with HIV. Transplantation from HIV-positive donors was noninferior to that from HIV-negative donors in the composite safety outcome. Survival and graft loss outcomes at 1 year were also comparable. The incidence of breakthrough HIV infection was higher among recipients of kidneys from HIV-positive donors, including one potential HIV superinfection, with no persistent failures of antiviral treatment. The study was limited by its intrinsic non-randomized design and heterogenous immunosuppression regimens. Nevertheless, these results provided evidence of noninferiority of kidney transplantation from donors with HIV to recipients with HIV and could help inform guidelines to improve access for this patient population.

Click here to read the study in NEJM 

Relevant Reading:  HIV-Positive–to–HIV-Positive Kidney Transplantation — Results at 3 to 5 Years

In-Depth [randomized controlled trial]: This was a multicenter observational study across 26 centers in the US to compare the transplantation of kidneys from deceased HIV-positive donors and HIV-negative donors to recipients with HIV. Persons with well-controlled HIV under antiretroviral therapy and end-stage renal disease 18 years of age or older, who met local criteria for kidney transplantation and consented to receive a kidney from a donor with HIV, were eligible for inclusion. Exclusion criteria included active opportunistic infections, a history of progressive multifocal leukoencephalopathy, and central nervous system lymphoma. Participants were eligible to receive a kidney from a donor with or without HIV, whichever was available first according to national Organ Procurement and Transplantation Network guidelines. The primary outcome was a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment (beyond 90 days), or opportunistic infection. In total, 408 transplantation candidates were enrolled, with 198 eventual recipients with a 1:1 ratio of kidneys from donors with and without HIV. The adjusted hazard ratio for the primary outcome was 1.00 (95% confidence interval [CI] 0.73-1.38), demonstrating noninferiority. Secondary outcomes were also comparable across the two recipient groups (donors with HIV versus without HIV): overall survival at 1 year (94% vs. 95%) and 3 years (85% vs. 87%), survival without graft loss at 1 year (93% vs. 90%) and 3 years (84% vs. 81%), and rejection at 1 year (13% vs. 21%) and 3 years (21% vs. 24%). The incidence of serious adverse events (75% vs. 77%), opportunistic infections (8% vs. 7%), and cancer (8% vs. 6%) was also similar between the groups. Notably, HIV breakthrough infection occurred more frequently in the HIV-positive donor group (10%) than the HIV-negative donor group (4%) (incidence rate ratio 3.14, 95% CI 1.02-9.63), with one potential HIV superinfection. These results provided strong evidence of noninferiority of kidney transplantation from donors with HIV to recipients with HIV compared with donors without HIV.

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