Living kidney donors with HIV: experience and outcomes from a case series by the HOPE in Action Consortium

HOPE in Action Investigators

doi:10.1016/j.lana.2023.100553

Living kidney donors with HIV: experience and outcomes from a case series by the HOPE in Action Consortium

HOPE in Action Investigators

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4 Scopus citations

Abstract

Background: Living kidney donation is possible for people living with HIV (PLWH) in the United States within research studies under the HIV Organ Policy Equity (HOPE) Act. There are concerns that donor nephrectomy may have an increased risk of end-stage renal disease (ESRD) in PLWH due to HIV-associated kidney disease and antiretroviral therapy (ART) nephrotoxicity. Here we report the first 3 cases of living kidney donors with HIV under the HOPE Act in the United States. Methods: Within the HOPE in Action Multicenter Consortium, we conducted a prospective study of living kidney donors with HIV. Pre-donation, we estimated the 9-year cumulative incidence of ESRD, performed genetic testing of apolipoprotein L1 (APOL1), excluding individuals with high-risk variants, and performed pre-donation kidney biopsies (HOPE Act requirement). The primary endpoint was ≥grade 3 nephrectomy-related adverse events (AEs) in year one. Post-donation, we monitored glomerular filtration rate (measured by iohexol/Tc-99m DTPA [mGFR] or estimated with serum creatinine [eGFR]), HIV RNA, CD4 count, and ART. Findings: There were three donors with two-four years of follow-up: a 35 year-old female, a 52 year-old male, and a 47 year-old male. Pre-donation 9-year estimated cumulative incidence of ESRD was 3.01, 8.01, and 7.76 per 10,000 persons, respectively. In two donors with APOL1 testing, no high-risk variants were detected. Biopsies from all three donors showed no kidney disease. Post-donation, two donors developed nephrectomy-related ≥grade 3 AEs: a medically-managed ileus and a laparoscopically-repaired incisional hernia. GFR declined from 103 to 84 mL/min/1.73 m² at four years (mGFR) in donor 1, from 77 to 52 mL/min/1.73 m² at three years (eGFR) in donor 2, and from 65 to 39 mL/min/1.73 m² at two years (eGFR) in donor 3. HIV RNA remained <20 copies/mL and CD4 count remained stable in all donors. Interpretation: The first three living kidney donors with HIV under the HOPE Act in the United States have had promising outcomes at two-four years, providing proof-of-concept to support living donation from PLWH to recipients with HIV. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Original language	English (US)
Article number	100553
Journal	The Lancet Regional Health - Americas
Volume	24
DOIs	https://doi.org/10.1016/j.lana.2023.100553
State	Published - Aug 2023

Funding

This research was performed as a project within the HOPE in Action clinical trial network, a collaborative clinical research project funded by National Institute of Allergy and Infectious Diseases ( U01AI134591 ). NM independently acknowledges receipt of financial assistance for non-medical ancillary donation expenses through the National Living Donor Assistance Center (NLDAC), which is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS); this assistance is available to all potential living donors in the United States without regard to HIV serostatus. The contents of this paper are those of the authors and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. National Institute of Allergy and Infectious Diseases, National Institutes of Health.This research was performed as a project within the HOPE in Action clinical trial network, a collaborative clinical research project funded by National Institute of Allergy and Infectious Diseases (U01AI134591). NM independently acknowledges receipt of financial assistance for non-medical ancillary donation expenses through the National Living Donor Assistance Center (NLDAC), which is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS); this assistance is available to all potential living donors in the United States without regard to HIV serostatus. The contents of this paper are those of the authors and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. HOPE in Action Investigators: From Cleveland Clinic Florida: Neerja Agrawal MD. From Columbia University Medical Center: Marcus Pereira MD MPH. From Drexel University: Karthik Ranganna MD MBA. From Duke University: Cameron Wolfe MBBS. From Emory University Transplant Center: Rachel Friedman-Moraco MD, William Kitchens MD PhD. From Indiana University: Oluwafisayo Adebiyi MD, Chandrashekhar Kubal MD PhD. From Johns Hopkins University: Andrew Cameron MD PhD, Niraj Desai MD, Christine Durand MD, Shane Ottmann MD, From Massachusetts General Hospital: Nahel Elias MD. From MedStar Georgetown Transplant Institute: Alexander Gilbert MD, Coleman Smith MD. From Methodist Health System Clinical Research Institute: Jose A. Castillo-Lugo MD. From Mount Sinai Hospital, Recanati-Miller Transplantation Institute: Sander Florman MD. From New York University Langone Transplant Institute: Dorry L. Segev MD PhD, Allan Massie PhD, Sapna Mehta MD. From Northwestern University: Valentina Stosor MD. From Ochsner Health: Jonathan Hand MD. From Perelman School of Medicine at the University of Pennsylvania: Emily Blumberg MD. From Rush University Medical Center: Carlos A. Q. Santos MD MPHS. From St. Barnabas Medical Center: Ryan Goldberg MD. From University of Alabama at Birmingham: Shikha Mehta MD, Robert Cannon MD. From University of Arkansas for Medical Sciences: Emmanouil Giorgakis MD MSc FRCS. From University of California, Los Angeles: Joanna Schaenman MD PhD. From University of California, San Diego: Saima Aslam MD MS. From University of California, San Francisco: Peter Stock MD PhD, Jennifer Price MD. From University of Cincinnati: Senu Apewokin MD FACP. From University of Colorado, Denver: Esther Benamu MD. From University of Illinois at Chicago: Mario Spaggiari MD. From University of Maryland, Institute of Human Virology: John Baddley, MD. From University of Miami, Miami Transplant Institute: Michele I. Morris MD, Jacques Simkins, MD. From University of Minnesota: Timothy Pruett MD. From University of Pittsburgh Medical Center: Ghady Haidar MD. From University of Texas Southwestern Medical Center: David Wojciechowski DO. From University of Virginia: Avinash Agarwal MD. From University of Tennessee Health and Science Center: Vasanthi Balaraman, MD. From Virginia Commonwealth University: Gaurav Gupta MD. From Washington University St. Louis: Will Chapman MD. From Weill Cornell Medicine: Thangamani Muthukumar MD, Catherine B. Small MD. From Yale School of Medicine: Maricar Malinis MD.

Keywords

HIV Organ Policy Equity Act
HIV donation
HIV to HIV transplantation
HOPE Act
Living kidney donation
Transplantation from donors with HIV to recipients with HIV

ASJC Scopus subject areas

Internal Medicine
Health Policy
Public Health, Environmental and Occupational Health

UN SDGs

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

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10.1016/j.lana.2023.100553

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@article{ff4c161068024a97873ee25c9e555043,

title = "Living kidney donors with HIV: experience and outcomes from a case series by the HOPE in Action Consortium",

abstract = "Background: Living kidney donation is possible for people living with HIV (PLWH) in the United States within research studies under the HIV Organ Policy Equity (HOPE) Act. There are concerns that donor nephrectomy may have an increased risk of end-stage renal disease (ESRD) in PLWH due to HIV-associated kidney disease and antiretroviral therapy (ART) nephrotoxicity. Here we report the first 3 cases of living kidney donors with HIV under the HOPE Act in the United States. Methods: Within the HOPE in Action Multicenter Consortium, we conducted a prospective study of living kidney donors with HIV. Pre-donation, we estimated the 9-year cumulative incidence of ESRD, performed genetic testing of apolipoprotein L1 (APOL1), excluding individuals with high-risk variants, and performed pre-donation kidney biopsies (HOPE Act requirement). The primary endpoint was ≥grade 3 nephrectomy-related adverse events (AEs) in year one. Post-donation, we monitored glomerular filtration rate (measured by iohexol/Tc-99m DTPA [mGFR] or estimated with serum creatinine [eGFR]), HIV RNA, CD4 count, and ART. Findings: There were three donors with two-four years of follow-up: a 35 year-old female, a 52 year-old male, and a 47 year-old male. Pre-donation 9-year estimated cumulative incidence of ESRD was 3.01, 8.01, and 7.76 per 10,000 persons, respectively. In two donors with APOL1 testing, no high-risk variants were detected. Biopsies from all three donors showed no kidney disease. Post-donation, two donors developed nephrectomy-related ≥grade 3 AEs: a medically-managed ileus and a laparoscopically-repaired incisional hernia. GFR declined from 103 to 84 mL/min/1.73 m2 at four years (mGFR) in donor 1, from 77 to 52 mL/min/1.73 m2 at three years (eGFR) in donor 2, and from 65 to 39 mL/min/1.73 m2 at two years (eGFR) in donor 3. HIV RNA remained <20 copies/mL and CD4 count remained stable in all donors. Interpretation: The first three living kidney donors with HIV under the HOPE Act in the United States have had promising outcomes at two-four years, providing proof-of-concept to support living donation from PLWH to recipients with HIV. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.",

keywords = "HIV Organ Policy Equity Act, HIV donation, HIV to HIV transplantation, HOPE Act, Living kidney donation, Transplantation from donors with HIV to recipients with HIV",

author = "{HOPE in Action Investigators} and Durand, {Christine M.} and Nina Martinez and Karl Neumann and Benedict, {Reed C.} and Baker, {Arthur W.} and Wolfe, {Cameron R.} and Valentina Stosor and Aneesha Shetty and Dietch, {Zachary C.} and Leah Goudy and Callegari, {Michelle A.} and Massie, {Allan B.} and Diane Brown and Willa Cochran and Abimereki Muzaale and Derek Fine and Tobian, {Aaron A.R.} and Winkler, {Cheryl A.} and {Al Ammary}, Fawaz and Segev, {Dorry L.} and Neerja Agrawal and Marcus Pereira and Karthik Ranganna and Cameron Wolfe and Rachel Friedman-Moraco and William Kitchens and Oluwafisayo Adebiyi and Chandrashekhar Kubal and Andrew Cameron and Niraj Desai and Christine Durand and Shane Ottmann and Nahel Elias and Alexander Gilbert and Coleman Smith and Castillo-Lugo, {Jose A.} and Sander Florman and Allan Massie and Sapna Mehta and Jonathan Hand and Emily Blumberg and Santos, {Carlos A.Q.} and Ryan Goldberg and Shikha Mehta and Robert Cannon and Emmanouil Giorgakis and Joanna Schaenman and Saima Aslam and Peter Stock and Jennifer Price",

note = "Publisher Copyright: {\textcopyright} 2023 The Author(s)",

year = "2023",

month = aug,

doi = "10.1016/j.lana.2023.100553",

language = "English (US)",

volume = "24",

journal = "The Lancet Regional Health - Americas",

issn = "2667-193X",

publisher = "Elsevier Ltd",

}

TY - JOUR

T1 - Living kidney donors with HIV

T2 - experience and outcomes from a case series by the HOPE in Action Consortium

AU - HOPE in Action Investigators

AU - Durand, Christine M.

AU - Martinez, Nina

AU - Neumann, Karl

AU - Benedict, Reed C.

AU - Baker, Arthur W.

AU - Wolfe, Cameron R.

AU - Stosor, Valentina

AU - Shetty, Aneesha

AU - Dietch, Zachary C.

AU - Goudy, Leah

AU - Callegari, Michelle A.

AU - Massie, Allan B.

AU - Brown, Diane

AU - Cochran, Willa

AU - Muzaale, Abimereki

AU - Fine, Derek

AU - Tobian, Aaron A.R.

AU - Winkler, Cheryl A.

AU - Al Ammary, Fawaz

AU - Segev, Dorry L.

AU - Agrawal, Neerja

AU - Pereira, Marcus

AU - Ranganna, Karthik

AU - Wolfe, Cameron

AU - Friedman-Moraco, Rachel

AU - Kitchens, William

AU - Adebiyi, Oluwafisayo

AU - Kubal, Chandrashekhar

AU - Cameron, Andrew

AU - Desai, Niraj

AU - Durand, Christine

AU - Ottmann, Shane

AU - Elias, Nahel

AU - Gilbert, Alexander

AU - Smith, Coleman

AU - Castillo-Lugo, Jose A.

AU - Florman, Sander

AU - Massie, Allan

AU - Mehta, Sapna

AU - Hand, Jonathan

AU - Blumberg, Emily

AU - Santos, Carlos A.Q.

AU - Goldberg, Ryan

AU - Mehta, Shikha

AU - Cannon, Robert

AU - Giorgakis, Emmanouil

AU - Schaenman, Joanna

AU - Aslam, Saima

AU - Stock, Peter

AU - Price, Jennifer

PY - 2023/8

Y1 - 2023/8

N2 - Background: Living kidney donation is possible for people living with HIV (PLWH) in the United States within research studies under the HIV Organ Policy Equity (HOPE) Act. There are concerns that donor nephrectomy may have an increased risk of end-stage renal disease (ESRD) in PLWH due to HIV-associated kidney disease and antiretroviral therapy (ART) nephrotoxicity. Here we report the first 3 cases of living kidney donors with HIV under the HOPE Act in the United States. Methods: Within the HOPE in Action Multicenter Consortium, we conducted a prospective study of living kidney donors with HIV. Pre-donation, we estimated the 9-year cumulative incidence of ESRD, performed genetic testing of apolipoprotein L1 (APOL1), excluding individuals with high-risk variants, and performed pre-donation kidney biopsies (HOPE Act requirement). The primary endpoint was ≥grade 3 nephrectomy-related adverse events (AEs) in year one. Post-donation, we monitored glomerular filtration rate (measured by iohexol/Tc-99m DTPA [mGFR] or estimated with serum creatinine [eGFR]), HIV RNA, CD4 count, and ART. Findings: There were three donors with two-four years of follow-up: a 35 year-old female, a 52 year-old male, and a 47 year-old male. Pre-donation 9-year estimated cumulative incidence of ESRD was 3.01, 8.01, and 7.76 per 10,000 persons, respectively. In two donors with APOL1 testing, no high-risk variants were detected. Biopsies from all three donors showed no kidney disease. Post-donation, two donors developed nephrectomy-related ≥grade 3 AEs: a medically-managed ileus and a laparoscopically-repaired incisional hernia. GFR declined from 103 to 84 mL/min/1.73 m2 at four years (mGFR) in donor 1, from 77 to 52 mL/min/1.73 m2 at three years (eGFR) in donor 2, and from 65 to 39 mL/min/1.73 m2 at two years (eGFR) in donor 3. HIV RNA remained <20 copies/mL and CD4 count remained stable in all donors. Interpretation: The first three living kidney donors with HIV under the HOPE Act in the United States have had promising outcomes at two-four years, providing proof-of-concept to support living donation from PLWH to recipients with HIV. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

AB - Background: Living kidney donation is possible for people living with HIV (PLWH) in the United States within research studies under the HIV Organ Policy Equity (HOPE) Act. There are concerns that donor nephrectomy may have an increased risk of end-stage renal disease (ESRD) in PLWH due to HIV-associated kidney disease and antiretroviral therapy (ART) nephrotoxicity. Here we report the first 3 cases of living kidney donors with HIV under the HOPE Act in the United States. Methods: Within the HOPE in Action Multicenter Consortium, we conducted a prospective study of living kidney donors with HIV. Pre-donation, we estimated the 9-year cumulative incidence of ESRD, performed genetic testing of apolipoprotein L1 (APOL1), excluding individuals with high-risk variants, and performed pre-donation kidney biopsies (HOPE Act requirement). The primary endpoint was ≥grade 3 nephrectomy-related adverse events (AEs) in year one. Post-donation, we monitored glomerular filtration rate (measured by iohexol/Tc-99m DTPA [mGFR] or estimated with serum creatinine [eGFR]), HIV RNA, CD4 count, and ART. Findings: There were three donors with two-four years of follow-up: a 35 year-old female, a 52 year-old male, and a 47 year-old male. Pre-donation 9-year estimated cumulative incidence of ESRD was 3.01, 8.01, and 7.76 per 10,000 persons, respectively. In two donors with APOL1 testing, no high-risk variants were detected. Biopsies from all three donors showed no kidney disease. Post-donation, two donors developed nephrectomy-related ≥grade 3 AEs: a medically-managed ileus and a laparoscopically-repaired incisional hernia. GFR declined from 103 to 84 mL/min/1.73 m2 at four years (mGFR) in donor 1, from 77 to 52 mL/min/1.73 m2 at three years (eGFR) in donor 2, and from 65 to 39 mL/min/1.73 m2 at two years (eGFR) in donor 3. HIV RNA remained <20 copies/mL and CD4 count remained stable in all donors. Interpretation: The first three living kidney donors with HIV under the HOPE Act in the United States have had promising outcomes at two-four years, providing proof-of-concept to support living donation from PLWH to recipients with HIV. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

KW - HIV Organ Policy Equity Act

KW - HIV donation

KW - HIV to HIV transplantation

KW - HOPE Act

KW - Living kidney donation

KW - Transplantation from donors with HIV to recipients with HIV

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DO - 10.1016/j.lana.2023.100553

M3 - Article

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VL - 24

JO - The Lancet Regional Health - Americas

JF - The Lancet Regional Health - Americas

M1 - 100553

ER -

Living kidney donors with HIV: experience and outcomes from a case series by the HOPE in Action Consortium

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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