Observational Study

. 2024 Oct 17;391(15):1390-1401.

doi: 10.1056/NEJMoa2403733.

Safety of Kidney Transplantation from Donors with HIV

Christine M Durand¹, Allan Massie¹, Sander Florman¹, Tao Liang¹, Meenakshi M Rana¹, Rachel Friedman-Moraco¹, Alexander Gilbert¹, Peter Stock¹, Sapna A Mehta¹, Shikha Mehta¹, Valentina Stosor¹, Marcus R Pereira¹, Michele I Morris¹, Jonathan Hand¹, Saima Aslam¹, Maricar Malinis¹, Ghady Haidar¹, Catherine B Small¹, Carlos A Q Santos¹, Joanna Schaenman¹, John Baddley¹, David Wojciechowski¹, Emily A Blumberg¹, Karthik Ranganna¹, Oluwafisayo Adebiyi¹, Nahel Elias¹, Jose A Castillo-Lugo¹, Emmanouil Giorgakis¹, Senu Apewokin¹, Diane Brown¹, Darin Ostrander¹, Yolanda Eby¹, Niraj Desai¹, Fizza Naqvi¹, Serena Bagnasco¹, Natasha Watson¹, Erica Brittain¹, Jonah Odim¹, Andrew D Redd¹, Aaron A R Tobian¹, Dorry L Segev¹; HOPE in Action Investigators

Collaborators, Affiliations

Collaborators

HOPE in Action Investigators:
Brittney Destin, Marcus Pereira, Theresa Lukose, Dominque Piquant, Suphamai Bunnapradist, H Albin Gritsch, Rosemary Silva, Adreanne Rivera, Jeffrey Veale, Dong Heun Lee, Karthik Ranganna, Rivka Elbein, Elizabeth Ferry, Jeryl Huckaby, William Kitchens, G Marshall Lyon, Aneesh K Mehta, Thomas Pearson, April Roberson, Oluwafisayo Adebiyi, Margaret Adebiyi, Olivia M Akinde, Serena Bagnasco, Brittany Barnaba, Gilad Bismut, Mary Grace Bowring, Diane Brown, Maggie Chahoud, Willa Cochran, Berlie DeJen, Niraj Desai, Christine Durand, Yolanda Eby, Reinaldo Fernandez, Naqvi Fizza, Feben Habtehyimer, Sarah Hussain, Morgan Keruly, Charles Kirby, Tao Liang, Jernelle Miller, Darin Ostrander, Michelle Prizzi, Grace Rozek, Jessica Ruff, Isabella Sengsouk, Haley Schmidt, Aaron Tobian, James Wiles, William Werbel, Nahel Elias, Olivia Hess, Margaret Thomas, Kerry Crisalli, Alexander Gilbert, Karen Castro, Sander S Florman, Brandy Haydel, Shirish Huprikar, Meenakshi M Rana, Erica Brittain, Megan Morsheimer, Jonah Odim, Thomas Quinn, Andrew Redd, Natasha Watson, Rebecca Dieter, Allan Massie, Sapna Mehta, Jennifer D Motter, Henry Neumann, Dorry Segev, Michelle Callegari, Leah Goudy, Valentina Stosor, Jonathan Hand, Angela Smith, Ari Cohen, Emily Blumberg, Maryann Najdzinowicz, Brianna Doby, Mark Mall, Carlos A Santos, Katherine Basinger, Jayme Locke, Shikha Mehta, Darnell Mompoint-Williams, Sushma Bhusal, Emmanouil Giorgakis, Rebecca Wilson, Saima Aslam, Kristin Mekeel, Layla Myers, Mita Shah, Ada Chao, Monica Fung, Peter Chin Hong, Garrett Roll, Rodney Rogers, Peter Stock, Joanna Schaenman, Senu Apewokin, Madison Cuffy, Samantha Kramer, Shimul Shah, Racheal Wilkinson, Lisa Anderson, John Baddley, Shweta Anjan, Adela Mattiazzi, Lissett Moni, Michele Morris, Carlos Munoz, Jacques Simkins, Isabel Vital, Ghady Haidar, Ken Ho, Kailey Hughes Kramer, Sarah McBeth, Diana L Pakstis, Fernanda Silveira, Ricardo M La Hoz, Jarrett Hubbard, Swee-Ling L Levea, Jennifer Nixon, Parsia Vagefi, David Wojciechowski, Candace Alleyne, Anna Gwak, Thangamani Muthukumar, Catherine Small, Britta Witting, Richard Formica, Sanjay Kulkarni, Maricar Malinis, Ricarda Tomlin

Affiliation

¹ From 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).

PMID: 39413376
PMCID: PMC11606542
DOI: 10.1056/NEJMoa2403733

Observational Study

Safety of Kidney Transplantation from Donors with HIV

Christine M Durand et al. N Engl J Med. 2024.

. 2024 Oct 17;391(15):1390-1401.

doi: 10.1056/NEJMoa2403733.

Authors

Collaborators

HOPE in Action Investigators:
Brittney Destin, Marcus Pereira, Theresa Lukose, Dominque Piquant, Suphamai Bunnapradist, H Albin Gritsch, Rosemary Silva, Adreanne Rivera, Jeffrey Veale, Dong Heun Lee, Karthik Ranganna, Rivka Elbein, Elizabeth Ferry, Jeryl Huckaby, William Kitchens, G Marshall Lyon, Aneesh K Mehta, Thomas Pearson, April Roberson, Oluwafisayo Adebiyi, Margaret Adebiyi, Olivia M Akinde, Serena Bagnasco, Brittany Barnaba, Gilad Bismut, Mary Grace Bowring, Diane Brown, Maggie Chahoud, Willa Cochran, Berlie DeJen, Niraj Desai, Christine Durand, Yolanda Eby, Reinaldo Fernandez, Naqvi Fizza, Feben Habtehyimer, Sarah Hussain, Morgan Keruly, Charles Kirby, Tao Liang, Jernelle Miller, Darin Ostrander, Michelle Prizzi, Grace Rozek, Jessica Ruff, Isabella Sengsouk, Haley Schmidt, Aaron Tobian, James Wiles, William Werbel, Nahel Elias, Olivia Hess, Margaret Thomas, Kerry Crisalli, Alexander Gilbert, Karen Castro, Sander S Florman, Brandy Haydel, Shirish Huprikar, Meenakshi M Rana, Erica Brittain, Megan Morsheimer, Jonah Odim, Thomas Quinn, Andrew Redd, Natasha Watson, Rebecca Dieter, Allan Massie, Sapna Mehta, Jennifer D Motter, Henry Neumann, Dorry Segev, Michelle Callegari, Leah Goudy, Valentina Stosor, Jonathan Hand, Angela Smith, Ari Cohen, Emily Blumberg, Maryann Najdzinowicz, Brianna Doby, Mark Mall, Carlos A Santos, Katherine Basinger, Jayme Locke, Shikha Mehta, Darnell Mompoint-Williams, Sushma Bhusal, Emmanouil Giorgakis, Rebecca Wilson, Saima Aslam, Kristin Mekeel, Layla Myers, Mita Shah, Ada Chao, Monica Fung, Peter Chin Hong, Garrett Roll, Rodney Rogers, Peter Stock, Joanna Schaenman, Senu Apewokin, Madison Cuffy, Samantha Kramer, Shimul Shah, Racheal Wilkinson, Lisa Anderson, John Baddley, Shweta Anjan, Adela Mattiazzi, Lissett Moni, Michele Morris, Carlos Munoz, Jacques Simkins, Isabel Vital, Ghady Haidar, Ken Ho, Kailey Hughes Kramer, Sarah McBeth, Diana L Pakstis, Fernanda Silveira, Ricardo M La Hoz, Jarrett Hubbard, Swee-Ling L Levea, Jennifer Nixon, Parsia Vagefi, David Wojciechowski, Candace Alleyne, Anna Gwak, Thangamani Muthukumar, Catherine Small, Britta Witting, Richard Formica, Sanjay Kulkarni, Maricar Malinis, Ricarda Tomlin

Affiliation

¹ From 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).

PMID: 39413376
PMCID: PMC11606542
DOI: 10.1056/NEJMoa2403733

Abstract

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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Figures

**Figure 1.**
Panel A shows the cumulative incidence of recipients with the primary outcome composite event of all-cause-mortality, graft failure, serious adverse event (SAE), HIV-breakthrough, persistent HIV failure, or opportunistic infection. 79/99 recipients in HIV D+/R+ had the primary outcome composite event, with 71 attributed to SAEs, 6 HIV-breakthroughs, 1 opportunistic infection, and 1 death. 77/99 recipients in HIV D−/R+ had the primary outcome composite event, with 70 attributed to SAEs, 3 graft failures, 2 HIV-breakthroughs, and 2 opportunistic infections. Median outcome-free time was 0.36 years (IQR, 0.05–2.08) in HIV D+/R+ and 0.34 years (IQR, 0.05–2.02) in HIV D−/R+. Panel B shows the adjusted relative risk (hazard ratio or incidence rate ratio) for each outcome. The shaded area indicates the pre-specified noninferiority margin of 3.0. Kaplan-Meier estimates of the subcomponents are shown in the Figure S2.

**Figure 2.**
Shown are the Kaplan-Meier estimates of patient survival (Panel A), all-cause graft survival (Panel B), and rejection-free survival (Panel C). Patient survival was 94% (95% CI, 87–97) in HIV D+/R+ vs. 95% (95% CI, 88–98) HIV D−/R+ at 1 year, and 85% (95% CI, 74–92) in HIV D+/R+ vs. 87% (95% CI, 77–93) in HIV D−/R+ at 3 years. 12 deaths were observed in HIV D+/R+ and 11 in HIV D−/R+. All-cause graft survival was 93% (95% CI, 86–97) in HIV D+/R+ vs. 90% (95% CI, 82–94) HIV D−/R+ at 1 year, and 84% (95% CI, 73–91) in HIV D+/R+ vs. 80% (95% CI, 70–87) in HIV D−/R+ at 3 years. Rejection was 13% (95% CI, 8–22) in HIV D+/R+ vs. 21% (95% CI, 14–31) HIV D−/R+ at 1 year, and 21% (95% CI, 13–31) in HIV D+/R+ vs. 24% (95% CI, 16–34) in HIV D−/R+ at 3 years.

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Comment in

Safety of Kidney Transplantation from Donors with HIV Infection.
Chen T, Shang G. Chen T, et al. N Engl J Med. 2025 Jan 9;392(2):204. doi: 10.1056/NEJMc2414602. N Engl J Med. 2025. PMID: 39778177 No abstract available.
Safety of Kidney Transplantation from Donors with HIV Infection. Reply.
Durand CM, Segev DL, Redd AD. Durand CM, et al. N Engl J Med. 2025 Jan 9;392(2):204-205. doi: 10.1056/NEJMc2414602. N Engl J Med. 2025. PMID: 39778178 No abstract available.

References

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Safety of Kidney Transplantation from Donors with HIV

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Safety of Kidney Transplantation from Donors with HIV

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