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Safety of Kidney Transplantation from Donors with HIV
Christine M Durand1, Allan Massie1, Sander Florman1
1From the Departments of Medicine (C.M.D., T.L., D.B., D.O., Y.E., F.N., A.D.R.), Surgery (N.D.), and Pathology (S.B., A.A.R.T.), Johns Hopkins University School of Medicine, Baltimore, the Department of Medicine, University of Maryland School of Medicine (J.B.), and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda (N.W., E.B., J.O., A.D.R.) - all in Maryland; the Department of Population Health, New York University (NYU) Grossman School of Medicine (A.M., D.L.S.), the Recanati-Miller Transplantation Institute, Mount Sinai Hospital (S.F.), the Department of Medicine, Icahn School of Medicine at Mount Sinai (M.M.R.), NYU Langone Transplant Institute (S.A.M., D.L.S.), the Department of Medicine, Columbia University Irving Medical Center (M.R.P.), and the Department of Medicine, Weill Cornell Medicine (C.B.S.) - all in New York; the Department of Medicine, Emory University, Atlanta (R.F.-M.); the Department of Medicine, Georgetown University, Washington, DC (A.G.); the Department of Surgery, University of California, San Francisco, San Francisco (P.S.), the Division of Infectious Diseases and Global Public Health, University of California, San Diego, La Jolla (S. Aslam), and the Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles (J.S.) - all in California; the Section of Transplant Nephrology, University of Alabama at Birmingham, Birmingham (S.M.); the Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine (V.S.), and the Division of Infectious Diseases, Rush University Medical Center (C.A.Q.S.) - both in Chicago; the Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami (M.I.M.); the Department of Medicine, Ochsner Health, New Orleans (J.H.); the Section of Infectious Diseases, Yale School of Medicine, New Haven, CT (M.M.); the Department of Medicine, University of Pittsburgh, Pittsburgh (G.H.), and the Department of Medicine, Perelman School of Medicine at the University of Pennsylvania (E.A.B.), and the Department of Medicine, Drexel University College of Medicine (K.R.), Philadelphia - all in Pennsylvania; the Department of Medicine, University of Texas Southwestern Medical Center (D.W.), and the Department of Medicine, Methodist Health System Clinical Research Institute (J.A.C.-L.) - both in Dallas; the Department of Medicine, Indiana University Health, Indianapolis (O.A.); the Department of Surgery, Massachusetts General Hospital, Boston (N.E.); the Department of Surgery, University of Arkansas for Medical Sciences, Little Rock (E.G.); and the Department of Medicine, University of Cincinnati College of Medicine, Cincinnati (S. Apewokin).
Background:
Kidney transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV is an emerging practice. It has been performed since 2016 under the U.S. congressional HIV Organ Policy Equity Act and is currently approved for research only. The Department of Health and Human Services is considering expanding the procedure to clinical practice, but data are limited to small case series that did not include donors without HIV as controls.
Methods:
In an observational study conducted at 26 U.S. centers, we compared transplantation of kidneys from deceased donors with HIV and donors without HIV to recipients with HIV. The primary outcome was a safety event (a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection), assessed for noninferiority (margin for the upper bound of the 95% confidence interval, 3.00). Secondary outcomes included overall survival, survival without graft loss, rejection, infection, cancer, and HIV superinfection.
Results:
We enrolled 408 transplantation candidates, of whom 198 received a kidney from a deceased donor; 99 received a kidney from a donor with HIV and 99 from a donor without HIV. The adjusted hazard ratio for the composite primary outcome was 1.00 (95% confidence interval [CI], 0.73 to 1.38), which showed noninferiority. The following secondary outcomes were similar whether the donor had HIV or not: 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, infections, surgical or vascular complications, and cancer was similar in the groups. The incidence of HIV breakthrough infection was higher among recipients of kidneys from donors with HIV (incidence rate ratio, 3.14; 95%, CI, 1.02 to 9.63), with one potential HIV superinfection among the 58 recipients in this group with sequence data and no persistent failures of HIV treatment.
Conclusions:
In this observational study of kidney transplantation in persons with HIV, transplantation from donors with HIV appeared to be noninferior to that from donors without HIV. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT03500315.).
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