Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results

Christine M. Durand; William Werbel; Brianna Doby; Diane Brown; Niraj M. Desai; Maricar Malinis; Jennifer Price; Peter Chin-Hong; Shikha Mehta; Rachel Friedman-Moraco; Nicole A. Turgeon; Alexander Gilbert; Michele I. Morris; Valentina Stosor; Nahel Elias; Saima Aslam; Carlos A.Q. Santos; Jonathan M. Hand; Jennifer Husson; Timothy L. Pruett; Avinash Agarwal; Oluwafisayo Adebiyi; Marcus Pereira; Catherine B. Small; Senu Apewokin; Dong Heun Lee; Ghady Haidar; Emily Blumberg; Sapna A. Mehta; Shirish Huprikar; Sander S. Florman; Andrew D. Redd; Aaron A.R. Tobian; Dorry L. Segev

doi:10.1111/ajt.15681

Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results

Christine M. Durand, William Werbel, Brianna Doby, Diane Brown, Niraj M. Desai, Maricar Malinis, Jennifer Price, Peter Chin-Hong, Shikha Mehta, Rachel Friedman-Moraco, Nicole A. Turgeon, Alexander Gilbert, Michele I. Morris, Valentina Stosor, Nahel Elias, Saima Aslam, Carlos A.Q. Santos, Jonathan M. Hand, Jennifer Husson, Timothy L. PruettAvinash Agarwal, Oluwafisayo Adebiyi, Marcus Pereira, Catherine B. Small, Senu Apewokin, Dong Heun Lee, Ghady Haidar, Emily Blumberg, Sapna A. Mehta, Shirish Huprikar, Sander S. Florman, Andrew D. Redd, Aaron A.R. Tobian, Dorry L. Segev

School of Medicine

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

2 Scopus citations

Original language	English (US)
Pages (from-to)	617-619
Number of pages	3
Journal	American Journal of Transplantation
Volume	20
Issue number	2
DOIs	https://doi.org/10.1111/ajt.15681
State	Published - Feb 1 2020

Keywords

United Network for Organ Sharing (UNOS)
clinical research/practice
donors and donation: deceased
ethics and public policy
infection and infectious agents - viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
infectious disease
kidney disease: infectious
kidney transplantation/nephrology
liver disease: infectious
liver transplantation/hepatology

ASJC Scopus subject areas

Immunology and Allergy
Transplantation
Pharmacology (medical)

Access to Document

10.1111/ajt.15681

Cite this

Durand, C. M., Werbel, W., Doby, B., Brown, D., Desai, N. M., Malinis, M., Price, J., Chin-Hong, P., Mehta, S., Friedman-Moraco, R., Turgeon, N. A., Gilbert, A., Morris, M. I., Stosor, V., Elias, N., Aslam, S., Santos, C. A. Q., Hand, J. M., Husson, J., ... Segev, D. L. (2020). Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results. American Journal of Transplantation, 20(2), 617-619. https://doi.org/10.1111/ajt.15681

Durand, CM , Werbel, W, Doby, B, Brown, D, Desai, NM, Malinis, M, Price, J, Chin-Hong, P, Mehta, S, Friedman-Moraco, R, Turgeon, NA, Gilbert, A, Morris, MI, Stosor, V, Elias, N, Aslam, S, Santos, CAQ, Hand, JM, Husson, J, Pruett, TL, Agarwal, A, Adebiyi, O, Pereira, M, Small, CB, Apewokin, S, Heun Lee, D, Haidar, G, Blumberg, E, Mehta, SA, Huprikar, S, Florman, SS, Redd, AD, Tobian, AAR & Segev, DL 2020, 'Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results', American Journal of Transplantation, vol. 20, no. 2, pp. 617-619. https://doi.org/10.1111/ajt.15681

@article{141239f41f6441889ef9072293c1d9c0,

title = "Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results",

keywords = "United Network for Organ Sharing (UNOS), clinical research/practice, donors and donation: deceased, ethics and public policy, infection and infectious agents - viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), infectious disease, kidney disease: infectious, kidney transplantation/nephrology, liver disease: infectious, liver transplantation/hepatology",

author = "Durand, {Christine M.} and William Werbel and Brianna Doby and Diane Brown and Desai, {Niraj M.} and Maricar Malinis and Jennifer Price and Peter Chin-Hong and Shikha Mehta and Rachel Friedman-Moraco and Turgeon, {Nicole A.} and Alexander Gilbert and Morris, {Michele I.} and Valentina Stosor and Nahel Elias and Saima Aslam and Santos, {Carlos A.Q.} and Hand, {Jonathan M.} and Jennifer Husson and Pruett, {Timothy L.} and Avinash Agarwal and Oluwafisayo Adebiyi and Marcus Pereira and Small, {Catherine B.} and Senu Apewokin and {Heun Lee}, Dong and Ghady Haidar and Emily Blumberg and Mehta, {Sapna A.} and Shirish Huprikar and Florman, {Sander S.} and Redd, {Andrew D.} and Tobian, {Aaron A.R.} and Segev, {Dorry L.}",

note = "Funding Information: Christine M. Durand William Werbel Brianna Doby Diane Brown Niraj M. Desai Maricar Malinis Jennifer Price Peter Chin‐Hong Shikha Mehta Rachel Friedman‐Moraco Nicole A. Turgeon Alexander Gilbert Michele I. Morris Valentina Stosor Nahel Elias Saima Aslam Carlos A.Q. Santos Jonathan M. Hand Jennifer Husson Timothy L. Pruett Avinash Agarwal Oluwafisayo Adebiyi Marcus Pereira Catherine B. Small Senu Apewokin Dong Heun Lee Ghady Haidar Emily Blumberg Sapna A. Mehta Shirish Huprikar Sander S. Florman Andrew D. Redd Aaron A.R. Tobian Dorry L. Segev Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland Department of Surgery Johns Hopkins University School of Medicine Baltimore Maryland Department of Medicine Yale School of Medicine New Haven Connecticut Department of Medicine University of California, San Francisco San Francisco California Department of Medicine University of Alabama School of Medicine Birmingham Alabama Department of Surgery Emory University Atlanta Georgia Medstar Georgetown Transplant Institute Medstar Georgetown University Hospital Washington DC Division of Infectious Diseases University of Miami Miller School of Medicine Miami Florida Department of Medicine Northwestern University Feinberg School of Medicine Chicago Illinois Department of Surgery Massachusetts General Hospital Harvard Medical School Boston Massachusetts Department of Medicine University of California, San Diego San Diego California Department of Medicine Rush University Medical Center Chicago Illinois Department of Medicine University of Queensland School of Medicine Ochsner Clinical School New Orleans Louisiana Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland Department of Surgery University of Minnesota Medical Center Minneapolis Minnesota Department of Surgery University of Virginia Medical Center Charlottesville Virginia Department of Medicine Indiana University School of Medicine Indianapolis Indiana Department of Medicine Columbia University Irving Medical Center New York New York Department of Medicine Weill Medical College of Cornell University New York New York Division of Infectious Diseases Department of Medicine University of Cincinnati Cincinnati Ohio Department of Medicine Drexel University Philadelphia Pennsylvania Division of Infectious Diseases University of Pittsburgh Medical Center Pittsburgh Pennsylvania Division of Infectious Diseases Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania Department of Medicine New York University School of Medicine New York New York Department of Medicine Icahn School of Medicine New York New York Recanati‐Miller Transplantation Institute The Mount Sinai Hospital New York New York Division of Intramural Research NIAID NIH Bethesda Maryland Department of Pathology Johns Hopkins University School of Medicine Baltimore Maryland clinical research/practice donors and donation: deceased ethics and public policy infection and infectious agents ‐ viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) infectious disease kidney disease: infectious kidney transplantation/nephrology liver disease: infectious liver transplantation/hepatology United Network for Organ Sharing (UNOS) National Institute of Allergy and Infectious Diseases 1R01AI120938 U01AI134591 U01AI138897 To the Editor: We represent a group of investigators funded by the National Institutes of Health (R01AI120938, U01AI134591, U01AI138897) to conduct a prospective multicenter study of the landscape of HIV‐infected (HIV+) donors and 2 prospective multicenter trials comparing outcomes between HIV+ recipients of HIV+ and non‐HIV+ donor kidneys and livers. These clinical trials are ongoing (NCT02602262, NCT03500315, NCT03734393). The study utilized data from the Organ Procurement and Transplantation Network (OPTN) database managed by UNOS under a federal contract. The authors concluded that 1‐year patient and graft survival in HIV+ recipients of HIV+ donors did not deviate from that observed in non‐HIV+ donor recipients. We read with interest the Brief Communication entitled “National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States” by Wilk et al of the United Network for Organ Sharing (UNOS). These assays have a low false‐positive rate (0.1%‐0.5%); however, given the number of deceased donors screened annually, we have estimated there should be 50‐100 donors with false‐positive HIV tests annually in the United States. Confirmatory testing is not routinely done or reported by the OPTN. As acknowledged by Wilk et al, an important limitation of the study is the inability of OPTN data to accurately identify donors with HIV infection. In their report, HIV+ donors were defined by any report of a positive HIV antibody (Ab), nucleic acid test (NAT), or antigen/antibody combination assay (Ab/Ag). Of the 56 donors with organs recovered for transplant under the HOPE Act between March 2016 and December 2018, there were 27 HIV+ kidney donors versus 23 non‐HIV+ donors with false‐positive HIV test results (46%). Similarly, there were 21 HIV+ liver donors versus 11 non‐HIV+ liver donors with false‐positive HIV testing (34%). Importantly, according to our data, there were actually no transplants using HIV+ donor organs donated after circulatory death. As such, the number of donors who are incorrectly identified as HIV+ in the UNOS cohort is significant. Since ≈40% of the donors labeled as HIV+ by Wilk et al were not actually infected with HIV, the comparisons of patient and graft survival between HIV‐ and HIV+ donor to HIV+ recipient transplantation are inaccurate. Providing transplant outcomes stratified by true HIV+ donor designation is outside the scope of this letter, but it is the primary goal of the National Institutes of Health–funded HOPE in Action clinical trials, which our group will report on when the appropriate amount of data has been collected. In practice, all donors regardless of risk designation are currently tested in this way. HIV Ab assays have higher false‐positive rates and are no longer recommended by the Centers for Disease Control and Prevention as first line in diagnostic algorithms. Thus, UNOS might consider eliminating the use of HIV Ab assays or require confirmatory testing. The transplant community would also benefit from further guidance on cases where HIV infection is excluded with confirmatory testing prior to organ recovery and whether organs including hearts, lungs, and pancreases from these donors could be allocated outside of HOPE studies. Finally, from a scientific standpoint in order to ensure accurate future analyses, the OPTN should consider adding data elements to identify donors with false‐positive HIV test results. The Wilk study highlights the need for UNOS to address the issue of donors with false‐positive HIV screens, both from a practical and scientific standpoint. OPTN policy requires that all increased‐risk donors have an HIV NAT in combination with either an HIV Ab or HIV Ag/Ab combination testing. As the HOPE Act continues to open the door to more potential donors for this patient population, we also hope that it decreases HIV‐related stigma in both the transplant and broader community. In the current era, all people living with HIV who develop end‐stage organ disease should be considered for solid organ transplantation as standard practice. We would emphasize that long‐term outcomes of HIV+ transplant recipients have been demonstrated to be comparable to those without HIV. ",

year = "2020",

month = feb,

day = "1",

doi = "10.1111/ajt.15681",

language = "English (US)",

volume = "20",

pages = "617--619",

journal = "American Journal of Transplantation",

issn = "1600-6135",

publisher = "Wiley-Blackwell",

number = "2",

}

TY - JOUR

T1 - Clarifying the HOPE Act landscape

T2 - The challenge of donors with false-positive HIV results

AU - Durand, Christine M.

AU - Werbel, William

AU - Doby, Brianna

AU - Brown, Diane

AU - Desai, Niraj M.

AU - Malinis, Maricar

AU - Price, Jennifer

AU - Chin-Hong, Peter

AU - Mehta, Shikha

AU - Friedman-Moraco, Rachel

AU - Turgeon, Nicole A.

AU - Gilbert, Alexander

AU - Morris, Michele I.

AU - Stosor, Valentina

AU - Elias, Nahel

AU - Aslam, Saima

AU - Santos, Carlos A.Q.

AU - Hand, Jonathan M.

AU - Husson, Jennifer

AU - Pruett, Timothy L.

AU - Agarwal, Avinash

AU - Adebiyi, Oluwafisayo

AU - Pereira, Marcus

AU - Small, Catherine B.

AU - Apewokin, Senu

AU - Heun Lee, Dong

AU - Haidar, Ghady

AU - Blumberg, Emily

AU - Mehta, Sapna A.

AU - Huprikar, Shirish

AU - Florman, Sander S.

AU - Redd, Andrew D.

AU - Tobian, Aaron A.R.

AU - Segev, Dorry L.

N1 - Funding Information: Christine M. Durand William Werbel Brianna Doby Diane Brown Niraj M. Desai Maricar Malinis Jennifer Price Peter Chin‐Hong Shikha Mehta Rachel Friedman‐Moraco Nicole A. Turgeon Alexander Gilbert Michele I. Morris Valentina Stosor Nahel Elias Saima Aslam Carlos A.Q. Santos Jonathan M. Hand Jennifer Husson Timothy L. Pruett Avinash Agarwal Oluwafisayo Adebiyi Marcus Pereira Catherine B. Small Senu Apewokin Dong Heun Lee Ghady Haidar Emily Blumberg Sapna A. Mehta Shirish Huprikar Sander S. Florman Andrew D. Redd Aaron A.R. Tobian Dorry L. Segev Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland Department of Surgery Johns Hopkins University School of Medicine Baltimore Maryland Department of Medicine Yale School of Medicine New Haven Connecticut Department of Medicine University of California, San Francisco San Francisco California Department of Medicine University of Alabama School of Medicine Birmingham Alabama Department of Surgery Emory University Atlanta Georgia Medstar Georgetown Transplant Institute Medstar Georgetown University Hospital Washington DC Division of Infectious Diseases University of Miami Miller School of Medicine Miami Florida Department of Medicine Northwestern University Feinberg School of Medicine Chicago Illinois Department of Surgery Massachusetts General Hospital Harvard Medical School Boston Massachusetts Department of Medicine University of California, San Diego San Diego California Department of Medicine Rush University Medical Center Chicago Illinois Department of Medicine University of Queensland School of Medicine Ochsner Clinical School New Orleans Louisiana Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland Department of Surgery University of Minnesota Medical Center Minneapolis Minnesota Department of Surgery University of Virginia Medical Center Charlottesville Virginia Department of Medicine Indiana University School of Medicine Indianapolis Indiana Department of Medicine Columbia University Irving Medical Center New York New York Department of Medicine Weill Medical College of Cornell University New York New York Division of Infectious Diseases Department of Medicine University of Cincinnati Cincinnati Ohio Department of Medicine Drexel University Philadelphia Pennsylvania Division of Infectious Diseases University of Pittsburgh Medical Center Pittsburgh Pennsylvania Division of Infectious Diseases Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania Department of Medicine New York University School of Medicine New York New York Department of Medicine Icahn School of Medicine New York New York Recanati‐Miller Transplantation Institute The Mount Sinai Hospital New York New York Division of Intramural Research NIAID NIH Bethesda Maryland Department of Pathology Johns Hopkins University School of Medicine Baltimore Maryland clinical research/practice donors and donation: deceased ethics and public policy infection and infectious agents ‐ viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) infectious disease kidney disease: infectious kidney transplantation/nephrology liver disease: infectious liver transplantation/hepatology United Network for Organ Sharing (UNOS) National Institute of Allergy and Infectious Diseases 1R01AI120938 U01AI134591 U01AI138897 To the Editor: We represent a group of investigators funded by the National Institutes of Health (R01AI120938, U01AI134591, U01AI138897) to conduct a prospective multicenter study of the landscape of HIV‐infected (HIV+) donors and 2 prospective multicenter trials comparing outcomes between HIV+ recipients of HIV+ and non‐HIV+ donor kidneys and livers. These clinical trials are ongoing (NCT02602262, NCT03500315, NCT03734393). The study utilized data from the Organ Procurement and Transplantation Network (OPTN) database managed by UNOS under a federal contract. The authors concluded that 1‐year patient and graft survival in HIV+ recipients of HIV+ donors did not deviate from that observed in non‐HIV+ donor recipients. We read with interest the Brief Communication entitled “National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States” by Wilk et al of the United Network for Organ Sharing (UNOS). These assays have a low false‐positive rate (0.1%‐0.5%); however, given the number of deceased donors screened annually, we have estimated there should be 50‐100 donors with false‐positive HIV tests annually in the United States. Confirmatory testing is not routinely done or reported by the OPTN. As acknowledged by Wilk et al, an important limitation of the study is the inability of OPTN data to accurately identify donors with HIV infection. In their report, HIV+ donors were defined by any report of a positive HIV antibody (Ab), nucleic acid test (NAT), or antigen/antibody combination assay (Ab/Ag). Of the 56 donors with organs recovered for transplant under the HOPE Act between March 2016 and December 2018, there were 27 HIV+ kidney donors versus 23 non‐HIV+ donors with false‐positive HIV test results (46%). Similarly, there were 21 HIV+ liver donors versus 11 non‐HIV+ liver donors with false‐positive HIV testing (34%). Importantly, according to our data, there were actually no transplants using HIV+ donor organs donated after circulatory death. As such, the number of donors who are incorrectly identified as HIV+ in the UNOS cohort is significant. Since ≈40% of the donors labeled as HIV+ by Wilk et al were not actually infected with HIV, the comparisons of patient and graft survival between HIV‐ and HIV+ donor to HIV+ recipient transplantation are inaccurate. Providing transplant outcomes stratified by true HIV+ donor designation is outside the scope of this letter, but it is the primary goal of the National Institutes of Health–funded HOPE in Action clinical trials, which our group will report on when the appropriate amount of data has been collected. In practice, all donors regardless of risk designation are currently tested in this way. HIV Ab assays have higher false‐positive rates and are no longer recommended by the Centers for Disease Control and Prevention as first line in diagnostic algorithms. Thus, UNOS might consider eliminating the use of HIV Ab assays or require confirmatory testing. The transplant community would also benefit from further guidance on cases where HIV infection is excluded with confirmatory testing prior to organ recovery and whether organs including hearts, lungs, and pancreases from these donors could be allocated outside of HOPE studies. Finally, from a scientific standpoint in order to ensure accurate future analyses, the OPTN should consider adding data elements to identify donors with false‐positive HIV test results. The Wilk study highlights the need for UNOS to address the issue of donors with false‐positive HIV screens, both from a practical and scientific standpoint. OPTN policy requires that all increased‐risk donors have an HIV NAT in combination with either an HIV Ab or HIV Ag/Ab combination testing. As the HOPE Act continues to open the door to more potential donors for this patient population, we also hope that it decreases HIV‐related stigma in both the transplant and broader community. In the current era, all people living with HIV who develop end‐stage organ disease should be considered for solid organ transplantation as standard practice. We would emphasize that long‐term outcomes of HIV+ transplant recipients have been demonstrated to be comparable to those without HIV.

PY - 2020/2/1

Y1 - 2020/2/1

KW - United Network for Organ Sharing (UNOS)

KW - clinical research/practice

KW - donors and donation: deceased

KW - ethics and public policy

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

KW - infectious disease

KW - kidney disease: infectious

KW - kidney transplantation/nephrology

KW - liver disease: infectious

KW - liver transplantation/hepatology

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UR - http://www.scopus.com/inward/citedby.url?scp=85075256118&partnerID=8YFLogxK

U2 - 10.1111/ajt.15681

DO - 10.1111/ajt.15681

M3 - Letter

C2 - 31675457

AN - SCOPUS:85075256118

SN - 1600-6135

VL - 20

SP - 617

EP - 619

JO - American Journal of Transplantation

JF - American Journal of Transplantation

IS - 2

ER -

Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results

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