DOI: 10.1111/ajt.15681 LETTER TO THE EDITOR Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results The Wilk study highlights the need for UNOS to address the To the Editor: We represent a group of investigators funded by the National issue of donors with false-positive HIV screens, both from a prac- Institutes of Health (R01AI120938, U01AI134591, U01AI138897) tical and scientific standpoint. OPTN policy requires that all in- to conduct a prospective multicenter study of the landscape of HIV- creased-risk donors have an HIV NAT in combination with either infected (HIV+) donors and 2 prospective multicenter trials compar- an HIV Ab or HIV Ag/Ab combination testing.4 In practice, all do- ing outcomes between HIV+ recipients of HIV+ and non-HIV+ donor nors regardless of risk designation are currently tested in this way. kidneys and livers. These clinical trials are ongoing (NCT02602262, HIV Ab assays have higher false-positive rates and are no longer NCT03500315, NCT03734393). recommended by the Centers for Disease Control and Prevention We read with interest the Brief Communication entitled as first line in diagnostic algorithms. Thus, UNOS might consider “National landscape of HIV+ to HIV+ kidney and liver transplanta- eliminating the use of HIV Ab assays or require confirmatory test- tion in the United States” by Wilk et al of the United Network for ing. The transplant community would also benefit from further 1 Organ Sharing (UNOS). The study utilized data from the Organ guidance on cases where HIV infection is excluded with confirma- Procurement and Transplantation Network (OPTN) database man- tory testing prior to organ recovery and whether organs including aged by UNOS under a federal contract. The authors concluded that hearts, lungs, and pancreases from these donors could be allocated 1-year patient and graft survival in HIV+ recipients of HIV+ donors outside of HOPE studies. Finally, from a scientific standpoint in did not deviate from that observed in non-HIV+ donor recipients. order to ensure accurate future analyses, the OPTN should con- 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 sider adding data elements to identify donors with false-positive HIV test results. In the current era, all people living with HIV who develop end- of a positive HIV antibody (Ab), nucleic acid test (NAT), or antigen/an- stage organ disease should be considered for solid organ transplan- tibody combination assay (Ab/Ag).1 These assays have a low false-pos- tation as standard practice. We would emphasize that long-term itive rate (0.1%-0.5%); however, given the number of deceased donors outcomes of HIV+ transplant recipients have been demonstrated to screened annually, we have estimated there should be 50-100 do- be comparable to those without HIV.5 As the HOPE Act continues to 2 open the door to more potential donors for this patient population, nors with false-positive HIV tests annually in the United States. Confirmatory testing is not routinely done or reported by the OPTN. As such, the number of donors who are incorrectly identified as we also hope that it decreases HIV-related stigma in both the transplant and broader community. HIV+ in the UNOS cohort is significant.3 Of the 56 donors with organs recovered for transplant under the HOPE Act between March D I S C LO S U R E 2016 and December 2018,1 there were 27 HIV+ kidney donors ver- The authors of this manuscript have conflicts of interest to dis- sus 23 non-HIV+ donors with false-positive HIV test results (46%). close as described by the American Journal of Transplantation. Similarly, there were 21 HIV+ liver donors versus 11 non-HIV+ liver Dorry L. Segev receives honoraria from Novartis to Speak donors with false-positive HIV testing (34%). Importantly, according about HOPE. The other authors have no conflicts of interest to to our data, there were actually no transplants using HIV+ donor disclose. organs donated after circulatory death. Since ≈40% of the donors labeled as HIV+ by Wilk et al were not K E Y WO R D S actually infected with HIV, the comparisons of patient and graft sur- clinical research/practice, donors and donation: deceased, ethics vival between HIV- and HIV+ donor to HIV+ recipient transplanta- and public policy, infection and infectious agents - viral: human tion are inaccurate. Providing transplant outcomes stratified by true immunodeficiency virus (HIV)/acquired immunodeficiency HIV+ donor designation is outside the scope of this letter, but it is syndrome (AIDS), infectious disease, kidney disease: infectious, the primary goal of the National Institutes of Health–funded HOPE kidney transplantation/nephrology, liver disease: infectious, liver in Action clinical trials, which our group will report on when the ap- transplantation/hepatology, United Network for Organ Sharing propriate amount of data has been collected. (UNOS) Am J Transplant. 2020;20:617–619. amjtransplant.com © 2019 The American Society of Transplantation and the American Society of Transplant Surgeons | 617 618 | LETTER TO THE EDITOR 10 Department of Surgery, Massachusetts General Hospital, 1 Christine M. Durand Harvard Medical School, Boston, Massachusetts William Werbel1 11 Department of Medicine, University of California, San Diego, Brianna Doby1 San Diego, California Diane Brown1 12 Department of Medicine, Rush University Medical Center, Niraj M. Desai2 Chicago, Illinois Maricar Malinis3 13 Department of Medicine, University of Queensland School of Jennifer Price 4 Peter Chin-Hong4 Medicine, Ochsner Clinical School, New Orleans, Louisiana 14 Institute of Human Virology, University of Maryland School of Shikha Mehta5 Medicine, Baltimore, Maryland Rachel Friedman-Moraco6 15 Department of Surgery, University of Minnesota Medical Nicole A. Turgeon6 Alexander Gilbert7 Center, Minneapolis, Minnesota 16 Department of Surgery, University of Virginia Medical Center, Michele I. Morris8 Charlottesville, Virginia Valentina Stosor 9 17 Department of Medicine, Indiana University School of Nahel Elias10 Medicine, Indianapolis, Indiana Saima Aslam11 18 Department of Medicine, Columbia University Irving Medical Carlos A.Q. Santos12 Center, New York, New York Jonathan M. Hand13 19 Department of Medicine, Weill Medical College of Cornell Jennifer Husson14 University, New York, New York Timothy L. Pruett15 20 Division of Infectious Diseases, Department of Medicine, Avinash Agarwal16 University of Cincinnati, Cincinnati, Ohio Oluwafisayo Adebiyi17 21 Department of Medicine, Drexel University, Philadelphia, Marcus Pereira18 Pennsylvania Catherine B. Small19 22 Division of Infectious Diseases, University of Pittsburgh Senu Apewokin20 Medical Center, Pittsburgh, Pennsylvania Dong Heun Lee21 23 Ghady Haidar22 Division of Infectious Diseases, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania Emily Blumberg23 Sapna A. Mehta 24 Department of Medicine, New York University School of 24 Shirish Huprikar25 Medicine, New York, New York 25 Department of Medicine, Icahn School of Medicine, New York, Sander S. Florman26 New York Andrew D. Redd27 26 Recanati-Miller Transplantation Institute, The Mount Sinai Aaron A.R. Tobian28 Hospital, New York, New York Dorry L. Segev2 27 Division of Intramural Research, NIAID, NIH, Bethesda, Maryland 1 Department of Medicine, Johns Hopkins University School of 28 Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland 2 3 Medicine, Baltimore, Maryland Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland Correspondence Department of Medicine, Yale School of Medicine, New Haven, Christine M. Durand Connecticut Email: christinedurand@jhmi.edu 4 Department of Medicine, University of California, San Francisco, San Francisco, California 5 Department of Medicine, University of Alabama School of Medicine, Birmingham, Alabama 6 Department of Surgery, Emory University, Atlanta, Georgia 7 Medstar Georgetown Transplant Institute, Medstar Georgetown University Hospital, Washington, DC 8 Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida 9 Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois ORCID Christine M. Durand Maricar Malinis Alexander Gilbert Nahel Elias https://orcid.org/0000-0002-5720-9994 https://orcid.org/0000-0001-5069-1880 https://orcid.org/0000-0001-6466-7347 Jonathan M. Hand Timothy L. Pruett Catherine B. Small Dorry L. Segev https://orcid.org/0000-0003-2605-9257 https://orcid.org/0000-0002-5752-9576 https://orcid.org/0000-0002-0715-8535 https://orcid.org/0000-0002-0601-6615 https://orcid.org/0000-0003-3205-1024 LETTER TO THE EDITOR REFERENCES 1. Wilk AR, Hunter RA, McBride MA, Klassen DK. National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States. Am J Transplant. 2019;19(9):2594-2605. 2. Durand CM, Halpern SE, Bowring MG, et al. Organs from deceased donors with false-positive HIV screening tests: an unexpected benefit of the HOPE act. Am J Transplant. 2018;18(10): 2579-2586. | 619 3. Wilk AR, Durand CM, Segev DL, Klassen D. Two years of the HOPE Act. Am J Transplant. 2017;17(suppl 3). https://atcmeetingabstracts. com/abstract/two-years-of-thehope-act/ 4. Network OPaT. https://optn.transplant.hrsa.gov/media/1200/optn_ policies.pdf#nameddest=Policy_15. Accessed August 2, 2019. 5. Locke JE, Mehta S, Reed RD, et al. A national study of outcomes among HIV-infected kidney transplant recipients. J Am Soc Nephrol. 2015;26(9):2222-2229.