William A Werbel1, Diane M Brown1, Oyinkansola T Kusemiju1, Brianna L Doby1, Shanti M Seaman1, Andrew D Redd1,2,3, Yolanda Eby2, Reinaldo E Fernandez1, Niraj M Desai4, Jernelle Miller2, Gilad A Bismut2, Charles S Kirby5, Haley A Schmidt2, William A Clarke2, Michael Seisa6, Christos J Petropoulos6, Thomas C Quinn1,2,3, Sander S Florman7, Shirish Huprikar8, Meenakshi M Rana8, Rachel J Friedman-Moraco9, Aneesh K Mehta9, Peter G Stock10, Jennifer C Price11, Valentina Stosor12, Shikha G Mehta13, Alexander J Gilbert14, Nahel Elias15, Michele I Morris16, Sapna A Mehta17, Catherine B Small18, Ghady Haidar19, Maricar Malinis20, Jennifer S Husson21, Marcus R Pereira22, Gaurav Gupta23, Jonathan Hand24, Varvara A Kirchner25, Avinash Agarwal26, Saima Aslam27, Emily A Blumberg28, Cameron R Wolfe29, Kevin Myer30, R Patrick Wood31, Nikole Neidlinger31,32, Sara Strell32, Marion Shuck33, Harry Wilkins33, Matthew Wadsworth34, Jennifer D Motter4, Jonah Odim35, Dorry L Segev4, Christine M Durand1, Aaron A R Tobian2. 1. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 2. Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 3. Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA. 4. Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 5. Department of Biochemistry, Cellular, and Molecular Biology, Johns Hopkins University, Baltimore, Maryland, USA. 6. Laboratory Corporation of America (LabCorp), South San Francisco, California, USA. 7. Recanati/Miller Transplantation Institute, The Mount Sinai Hospital, New York City, New York, USA. 8. Department of Medicine, Division of Infectious Diseases, The Mount Sinai Hospital, New York City, New York, USA. 9. Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA. 10. Department of Surgery, University of California San Francisco, San Francisco, California, USA. 11. Department of Medicine, University of California San Francisco, San Francisco, California, USA. 12. Division of Infectious Disease and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. 13. Section of Transplant Nephrology, The University of Alabama at Birmingham, Birmingham, Alabama, USA. 14. MedStar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC, USA. 15. Department of Surgery, Division of Transplant Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA. 16. Department of Medicine, Division of Infectious Diseases, University of Miami, Miami, Florida, USA. 17. New York University Langone Transplant Institute, New York University Grossman School of Medicine, New York, New York, USA. 18. Department of Medicine, Division of Infectious Diseases, Weill Cornell Medical College, New York, New York, USA. 19. Department of Medicine, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 20. Department of Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, Connecticut, USA. 21. Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA. 22. Department of Medicine, Division of Infectious Diseases, Columbia University Medical Center, New York, New York, USA. 23. Department of Medicine, Division of Nephrology, Virginia Commonwealth University, Richmond, Virginia, USA. 24. Department of Infectious Diseases, Ochsner Clinic Foundation, New Orleans, Louisiana, USA. 25. Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA. 26. Department of Surgery, Division of Transplantation, University of Virginia, Charlottesville, Virginia, USA. 27. Department of Medicine, Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, California, USA. 28. Department of Medicine, Division of Infectious Diseases, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA. 29. Department of Medicine, Division of Infectious Diseases, Duke University School of Medicine, Durham, North Carolina, USA. 30. LifeGift, Houston, Texas, USA. 31. Department of Surgery, Division of Transplantation, University of Wisconsin, Madison, Wisconsin, USA. 32. UW Health Organ Procurement Organization, Madison, Wisconsin, USA. 33. Gift of Hope, Chicago, Illinois, USA. 34. Life Connection, Dayton, Ohio, USA. 35. Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Abstract
BACKGROUND: Organ transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+) presents risks of donor-derived infections. Understanding clinical, immunologic, and virologic characteristics of HIV-positive donors is critical for safety. METHODS: We performed a prospective study of donors with HIV-positive and HIV false-positive (FP) test results within the HIV Organ Policy Equity (HOPE) Act in Action studies of HIV D+/R+ transplantation (ClinicalTrials.gov NCT02602262, NCT03500315, and NCT03734393). We compared clinical characteristics in HIV-positive versus FP donors. We measured CD4 T cells, HIV viral load (VL), drug resistance mutations (DRMs), coreceptor tropism, and serum antiretroviral therapy (ART) detection, using mass spectrometry in HIV-positive donors. RESULTS: Between March 2016 and March 2020, 92 donors (58 HIV positive, 34 FP), representing 98.9% of all US HOPE donors during this period, donated 177 organs (131 kidneys and 46 livers). Each year the number of donors increased. The prevalence of hepatitis B (16% vs 0%), syphilis (16% vs 0%), and cytomegalovirus (CMV; 91% vs 58%) was higher in HIV-positive versus FP donors; the prevalences of hepatitis C viremia were similar (2% vs 6%). Most HIV-positive donors (71%) had a known HIV diagnosis, of whom 90% were prescribed ART and 68% had a VL <400 copies/mL. The median CD4 T-cell count (interquartile range) was 194/µL (77-331/µL), and the median CD4 T-cell percentage was 27.0% (16.8%-36.1%). Major HIV DRMs were detected in 42%, including nonnucleoside reverse-transcriptase inhibitors (33%), integrase strand transfer inhibitors (4%), and multiclass (13%). Serum ART was detected in 46% and matched ART by history. CONCLUSION: The use of HIV-positive donor organs is increasing. HIV DRMs are common, yet resistance that would compromise integrase strand transfer inhibitor-based regimens is rare, which is reassuring regarding safety.
BACKGROUND: Organ transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+) presents risks of donor-derived infections. Understanding clinical, immunologic, and virologic characteristics of HIV-positive donors is critical for safety. METHODS: We performed a prospective study of donors with HIV-positive and HIV false-positive (FP) test results within the HIV Organ Policy Equity (HOPE) Act in Action studies of HIV D+/R+ transplantation (ClinicalTrials.gov NCT02602262, NCT03500315, and NCT03734393). We compared clinical characteristics in HIV-positive versus FP donors. We measured CD4 T cells, HIV viral load (VL), drug resistance mutations (DRMs), coreceptor tropism, and serum antiretroviral therapy (ART) detection, using mass spectrometry in HIV-positive donors. RESULTS: Between March 2016 and March 2020, 92 donors (58 HIV positive, 34 FP), representing 98.9% of all US HOPE donors during this period, donated 177 organs (131 kidneys and 46 livers). Each year the number of donors increased. The prevalence of hepatitis B (16% vs 0%), syphilis (16% vs 0%), and cytomegalovirus (CMV; 91% vs 58%) was higher in HIV-positive versus FP donors; the prevalences of hepatitis C viremia were similar (2% vs 6%). Most HIV-positive donors (71%) had a known HIV diagnosis, of whom 90% were prescribed ART and 68% had a VL <400 copies/mL. The median CD4 T-cell count (interquartile range) was 194/µL (77-331/µL), and the median CD4 T-cell percentage was 27.0% (16.8%-36.1%). Major HIV DRMs were detected in 42%, including nonnucleoside reverse-transcriptase inhibitors (33%), integrase strand transfer inhibitors (4%), and multiclass (13%). Serum ART was detected in 46% and matched ART by history. CONCLUSION: The use of HIV-positive donor organs is increasing. HIV DRMs are common, yet resistance that would compromise integrase strand transfer inhibitor-based regimens is rare, which is reassuring regarding safety.
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