Safety of Kidney Transplantation from Donors with HIV.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
17 Oct 2024
17 Oct 2024
Historique:
medline:
16
10
2024
pubmed:
16
10
2024
entrez:
16
10
2024
Statut:
ppublish
Résumé
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. 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. 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. 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.).
Sections du résumé
BACKGROUND
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
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
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
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.).
Identifiants
pubmed: 39413376
doi: 10.1056/NEJMoa2403733
doi:
Banques de données
ClinicalTrials.gov
['NCT03500315']
Types de publication
Journal Article
Observational Study
Multicenter Study
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1390-1401Subventions
Organisme : NIH HHS
ID : R01AI120938
Pays : United States
Organisme : NIH HHS
ID : R01DK131926
Pays : United States
Organisme : NIH HHS
ID : U01AI134591
Pays : United States
Organisme : NIH HHS
ID : U01AI138897
Pays : United States
Organisme : NIH HHS
ID : U01AI177211
Pays : United States
Investigateurs
Brittney Destin
(B)
Marcus Pereira
(M)
Theresa Lukose
(T)
Dominque Piquant
(D)
Suphamai Bunnapradist
(S)
H Albin Gritsch
(HA)
Rosemary Silva
(R)
Adreanne Rivera
(A)
Jeffrey Veale
(J)
Dong Heun Lee
(DH)
Karthik Ranganna
(K)
Rivka Elbein
(R)
Elizabeth Ferry
(E)
Jeryl Huckaby
(J)
William Kitchens
(W)
G Marshall Lyon
(GM)
Aneesh K Mehta
(AK)
Thomas Pearson
(T)
April Roberson
(A)
Oluwafisayo Adebiyi
(O)
Margaret Adebiyi
(M)
Olivia M Akinde
(OM)
Serena Bagnasco
(S)
Brittany Barnaba
(B)
Gilad Bismut
(G)
Mary Grace Bowring
(MG)
Diane Brown
(D)
Maggie Chahoud
(M)
Willa Cochran
(W)
Berlie DeJen
(B)
Niraj Desai
(N)
Christine Durand
(C)
Yolanda Eby
(Y)
Reinaldo Fernandez
(R)
Naqvi Fizza
(N)
Feben Habtehyimer
(F)
Sarah Hussain
(S)
Morgan Keruly
(M)
Charles Kirby
(C)
Tao Liang
(T)
Jernelle Miller
(J)
Darin Ostrander
(D)
Michelle Prizzi
(M)
Grace Rozek
(G)
Jessica Ruff
(J)
Isabella Sengsouk
(I)
Haley Schmidt
(H)
Aaron Tobian
(A)
James Wiles
(J)
William Werbel
(W)
Nahel Elias
(N)
Olivia Hess
(O)
Margaret Thomas
(M)
Kerry Crisalli
(K)
Alexander Gilbert
(A)
Karen Castro
(K)
Sander S Florman
(SS)
Brandy Haydel
(B)
Shirish Huprikar
(S)
Meenakshi M Rana
(MM)
Erica Brittain
(E)
Megan Morsheimer
(M)
Jonah Odim
(J)
Thomas Quinn
(T)
Andrew Redd
(A)
Natasha Watson
(N)
Rebecca Dieter
(R)
Allan Massie
(A)
Sapna Mehta
(S)
Jennifer D Motter
(JD)
Henry Neumann
(H)
Dorry Segev
(D)
Michelle Callegari
(M)
Leah Goudy
(L)
Valentina Stosor
(V)
Jonathan Hand
(J)
Angela Smith
(A)
Ari Cohen
(A)
Emily Blumberg
(E)
Maryann Najdzinowicz
(M)
Brianna Doby
(B)
Mark Mall
(M)
Carlos A Santos
(CA)
Katherine Basinger
(K)
Jayme Locke
(J)
Shikha Mehta
(S)
Darnell Mompoint-Williams
(D)
Sushma Bhusal
(S)
Emmanouil Giorgakis
(E)
Rebecca Wilson
(R)
Saima Aslam
(S)
Kristin Mekeel
(K)
Layla Myers
(L)
Mita Shah
(M)
Ada Chao
(A)
Monica Fung
(M)
Peter Chin Hong
(P)
Garrett Roll
(G)
Rodney Rogers
(R)
Peter Stock
(P)
Joanna Schaenman
(J)
Senu Apewokin
(S)
Madison Cuffy
(M)
Samantha Kramer
(S)
Shimul Shah
(S)
Racheal Wilkinson
(R)
Lisa Anderson
(L)
John Baddley
(J)
Shweta Anjan
(S)
Adela Mattiazzi
(A)
Lissett Moni
(L)
Michele Morris
(M)
Carlos Munoz
(C)
Jacques Simkins
(J)
Isabel Vital
(I)
Ghady Haidar
(G)
Ken Ho
(K)
Kailey Hughes Kramer
(K)
Sarah McBeth
(S)
Diana L Pakstis
(DL)
Fernanda Silveira
(F)
Ricardo M La Hoz
(RM)
Jarrett Hubbard
(J)
Swee-Ling L Levea
(SL)
Jennifer Nixon
(J)
Parsia Vagefi
(P)
David Wojciechowski
(D)
Candace Alleyne
(C)
Anna Gwak
(A)
Thangamani Muthukumar
(T)
Catherine Small
(C)
Britta Witting
(B)
Richard Formica
(R)
Sanjay Kulkarni
(S)
Maricar Malinis
(M)
Ricarda Tomlin
(R)
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Copyright © 2024 Massachusetts Medical Society.