A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action

the HOPE in Action Investigators

doi:10.1111/ajt.16205

A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action

the HOPE in Action Investigators

Medicine, Infectious Diseases Division

Research output: Contribution to journal › Article › peer-review

58 Scopus citations

Abstract

HIV-positive donor to HIV-positive recipient (HIV D+/R+) transplantation is permitted in the United States under the HIV Organ Policy Equity Act. To explore safety and the risk attributable to an HIV+ donor, we performed a prospective multicenter pilot study comparing HIV D+/R+ vs HIV-negative donor to HIV+ recipient (HIV D−/R+) kidney transplantation (KT). From 3/2016 to 7/2019 at 14 centers, there were 75 HIV+ KTs: 25 D+ and 50 D− (22 recipients from D− with false positive HIV tests). Median follow-up was 1.7 years. There were no deaths nor differences in 1-year graft survival (91% D+ vs 92% D−, P =.9), 1-year mean estimated glomerular filtration rate (63 mL/min D+ vs 57 mL/min D−, P =.31), HIV breakthrough (4% D+ vs 6% D−, P >.99), infectious hospitalizations (28% vs 26%, P =.85), or opportunistic infections (16% vs 12%, P =.72). One-year rejection was higher for D+ recipients (50% vs 29%, HR: 1.83, 95% CI 0.84-3.95, P =.13) but did not reach statistical significance; rejection was lower with lymphocyte-depleting induction (21% vs 44%, HR: 0.33, 95% CI 0.21-0.87, P =.03). In this multicenter pilot study directly comparing HIV D+/R+ with HIV D−/R+ KT, overall transplant and HIV outcomes were excellent; a trend toward higher rejection with D+ raises concerns that merit further investigation.

Original language	English (US)
Pages (from-to)	1754-1764
Number of pages	11
Journal	American Journal of Transplantation
Volume	21
Issue number	5
DOIs	https://doi.org/10.1111/ajt.16205
State	Published - May 2021

Funding

The authors of this manuscript have conflict of interests to disclose as described by the . CM Durand reports serving on a grant review committee for Gilead Sciences as well as research grants paid to the institution from Abbvie, Bristol Meyers Squibb, GlaxoSmithKline, Merck Dome & Sharp Corporation, and Viiv Healthcare. DLSegev reports speaking honoraria from Novartis and Sanofi and consulting for Sanofi, Novartis, and CSL Behring. Fizza Naqvi has received grant funding from CareDx. Shikha Mehta has received grant funding from and honoraria from CareDx. Catherine B. Small has received grants paid to her institution from GlaxoSmithKline, ViiV, Abbott, Merck, Gilead, Chimerix, Shire, Schering, Ablynx, and Janssen. Jennifer Husson has received grant funding through Merck, Sharpe & Dohme, and Intercept Pharmaceuticals. The American Journal of Transplantation This work was supported by the by NIH’s National Institute of Allergy and Infectious Diseases grant numbers 1P30AI094189 (Johns Hopkins Center for AIDS Research), 1R01AI120938 (Tobian), U01AI138897 (Durand/Segev), and U01AI134591 (Durand/Segev) and in part by the Division of Intramural Research, NIAID, NIH (Quinn and Redd) and the Regional Oncology Research Center, 3P30CA006973 NCI/NIH (Nelson). The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. This work was supported by the by NIH’s National Institute of Allergy and Infectious Diseases grant numbers 1P30AI094189 (Johns Hopkins Center for AIDS Research), 1R01AI120938 (Tobian), U01AI138897 (Durand/Segev), and U01AI134591 (Durand/Segev) and in part by the Division of Intramural Research, NIAID, NIH (Quinn and Redd) and the Regional Oncology Research Center, 3P30CA006973 NCI/NIH (Nelson). The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. From Johns Hopkins University School of Medicine/Johns Hopkins Hospital: Oyinkansola Kusemiju MPH, Charles Kirby BS, Jernelle Miller BA, Gilad Bismut BA, Ethan Klock BS, Haley Schmidt BA, Willa V. Cochran CRNP, Michelle Morrison BSN, Brian Boyarsky MD, Sarah Rasmussen BA, Juli Bollinger MS, Jeremy Sugarman MD. From The Mount Sinai Hospital, Recanati-Miller Transplantation Institute: Brandy M. Haydel CCRC. From University of Alabama at Birmingham: Darnell Mompoint-Williams CRNP DNP and Jayme E. Locke MD MPH. From University of California San Diego: Saima Aslam MD MS. From University of California San Francisco: Rodney Rogers and Ada Chao. From University of California Los Angeles: Joanna Schaenman MD PhD. From Yale School of Medicine: Maricar Malinis MD and Ricarda Tomlin BS CCRP. From MedStar Georgetown Transplant Institute: Margaret Coakley RN, Aleya Akhran RN, Joseph Timpone MD, Alyssa Stucke BS. From Emory University Transplant Center: Thomas Pearson MD, Aneesh K. Mehta MD, G. Marshall Lyon MD, William Kitchens MD PhD, Jeryl Huckaby MSCRA CCRC, Rivka Elbein RN BSN, April Roberson RN, Elizabeth Ferry RN. From Northwestern University: Leah Goudy RN BSN and Lorenzo Gallon MD. From Indiana University: Jeanne M. Chen BS PharmD. From Institute of Human Virology at the University of Maryland School of Medicine: Ilise D. Marrazzo RN BSN MPH. From Columbia University Medical Center: Marcus Pereira MD MPH. From Icahn School of Medicine at Mount Sinai: Brandy M. Haydel CCRC. From Weill Cornell Medicine: Thangamani Muthukumar MD, Transplant/Oncology Infectious Diseases Clinical Research Unit, Division of Transplant Surgery Research Group. From NYU Langone Transplant Institute: Elaina P. Weldon MSN, Elizabeth Klein. From University of Pittsburgh: Kailey Hughes MPH, Diana Lynn Pakstis RN BSN MBA, Fernanda Silveira MD MS, Ghady Haidar MD. From University of Pennsylvania: Emily A. Blumberg MD, Ty Dunn MD, Deirdre Sawinski MD, Eileen Donaghy CRNP. From University of Virginia: Jamie Nagy. From Virginia Commonwealth University: Nathaniel Brigle CCRP.

Keywords

clinical research/practice
clinical trial
donors and donation: deceased
ethics and public policy
infection and infectious agents
infection and infectious agents – viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
infectious disease
kidney transplantation/nephrology
law/legislation
rejection

ASJC Scopus subject areas

Transplantation
Pharmacology (medical)
Immunology and Allergy

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1111/ajt.16205

Cite this

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title = "A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action",

abstract = "HIV-positive donor to HIV-positive recipient (HIV D+/R+) transplantation is permitted in the United States under the HIV Organ Policy Equity Act. To explore safety and the risk attributable to an HIV+ donor, we performed a prospective multicenter pilot study comparing HIV D+/R+ vs HIV-negative donor to HIV+ recipient (HIV D−/R+) kidney transplantation (KT). From 3/2016 to 7/2019 at 14 centers, there were 75 HIV+ KTs: 25 D+ and 50 D− (22 recipients from D− with false positive HIV tests). Median follow-up was 1.7 years. There were no deaths nor differences in 1-year graft survival (91% D+ vs 92% D−, P =.9), 1-year mean estimated glomerular filtration rate (63 mL/min D+ vs 57 mL/min D−, P =.31), HIV breakthrough (4% D+ vs 6% D−, P >.99), infectious hospitalizations (28% vs 26%, P =.85), or opportunistic infections (16% vs 12%, P =.72). One-year rejection was higher for D+ recipients (50% vs 29%, HR: 1.83, 95% CI 0.84-3.95, P =.13) but did not reach statistical significance; rejection was lower with lymphocyte-depleting induction (21% vs 44%, HR: 0.33, 95% CI 0.21-0.87, P =.03). In this multicenter pilot study directly comparing HIV D+/R+ with HIV D−/R+ KT, overall transplant and HIV outcomes were excellent; a trend toward higher rejection with D+ raises concerns that merit further investigation.",

keywords = "clinical research/practice, clinical trial, donors and donation: deceased, ethics and public policy, infection and infectious agents, infection and infectious agents – viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), infectious disease, kidney transplantation/nephrology, law/legislation, rejection",

author = "{the HOPE in Action Investigators} and Durand, {Christine M.} and Wanying Zhang and Brown, {Diane M.} and Sile Yu and Niraj Desai and Redd, {Andrew D.} and Bagnasco, {Serena M.} and Naqvi, {Fizza F.} and Shanti Seaman and Doby, {Brianna L.} and Darin Ostrander and Bowring, {Mary Grace} and Yolanda Eby and Fernandez, {Reinaldo E.} and Rachel Friedman-Moraco and Nicole Turgeon and Peter Stock and Peter Chin-Hong and Shikha Mehta and Valentina Stosor and Small, {Catherine B.} and Gaurav Gupta and Mehta, {Sapna A.} and Wolfe, {Cameron R.} and Jennifer Husson and Alexander Gilbert and Matthew Cooper and Oluwafisayo Adebiyi and Avinash Agarwal and Elmi Muller and Quinn, {Thomas C.} and Jonah Odim and Shirish Huprikar and Sander Florman and Massie, {Allan B.} and Tobian, {Aaron A.R.} and Segev, {Dorry L.}",

note = "Publisher Copyright: {\textcopyright} 2020 The American Society of Transplantation and the American Society of Transplant Surgeons",

year = "2021",

month = may,

doi = "10.1111/ajt.16205",

language = "English (US)",

volume = "21",

pages = "1754--1764",

journal = "American Journal of Transplantation",

issn = "1600-6135",

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T1 - A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation

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AU - Durand, Christine M.

AU - Zhang, Wanying

AU - Brown, Diane M.

AU - Yu, Sile

AU - Desai, Niraj

AU - Redd, Andrew D.

AU - Bagnasco, Serena M.

AU - Naqvi, Fizza F.

AU - Seaman, Shanti

AU - Doby, Brianna L.

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AU - Bowring, Mary Grace

AU - Eby, Yolanda

AU - Fernandez, Reinaldo E.

AU - Friedman-Moraco, Rachel

AU - Turgeon, Nicole

AU - Stock, Peter

AU - Chin-Hong, Peter

AU - Mehta, Shikha

AU - Stosor, Valentina

AU - Small, Catherine B.

AU - Gupta, Gaurav

AU - Mehta, Sapna A.

AU - Wolfe, Cameron R.

AU - Husson, Jennifer

AU - Gilbert, Alexander

AU - Cooper, Matthew

AU - Adebiyi, Oluwafisayo

AU - Agarwal, Avinash

AU - Muller, Elmi

AU - Quinn, Thomas C.

AU - Odim, Jonah

AU - Huprikar, Shirish

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AB - HIV-positive donor to HIV-positive recipient (HIV D+/R+) transplantation is permitted in the United States under the HIV Organ Policy Equity Act. To explore safety and the risk attributable to an HIV+ donor, we performed a prospective multicenter pilot study comparing HIV D+/R+ vs HIV-negative donor to HIV+ recipient (HIV D−/R+) kidney transplantation (KT). From 3/2016 to 7/2019 at 14 centers, there were 75 HIV+ KTs: 25 D+ and 50 D− (22 recipients from D− with false positive HIV tests). Median follow-up was 1.7 years. There were no deaths nor differences in 1-year graft survival (91% D+ vs 92% D−, P =.9), 1-year mean estimated glomerular filtration rate (63 mL/min D+ vs 57 mL/min D−, P =.31), HIV breakthrough (4% D+ vs 6% D−, P >.99), infectious hospitalizations (28% vs 26%, P =.85), or opportunistic infections (16% vs 12%, P =.72). One-year rejection was higher for D+ recipients (50% vs 29%, HR: 1.83, 95% CI 0.84-3.95, P =.13) but did not reach statistical significance; rejection was lower with lymphocyte-depleting induction (21% vs 44%, HR: 0.33, 95% CI 0.21-0.87, P =.03). In this multicenter pilot study directly comparing HIV D+/R+ with HIV D−/R+ KT, overall transplant and HIV outcomes were excellent; a trend toward higher rejection with D+ raises concerns that merit further investigation.

KW - clinical research/practice

KW - clinical trial

KW - donors and donation: deceased

KW - ethics and public policy

KW - infection and infectious agents

KW - infection and infectious agents – viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)

KW - infectious disease

KW - kidney transplantation/nephrology

KW - law/legislation

KW - rejection

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A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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