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CHARACTERIZATION OF HUMAN IMMUNODEFCIENCY VIRUS (HIV) INFECTION IN CISGENDER MEN AND TRANSGENDER WOMEN WHO HAVE SEX WITH MEN RECEIVING INJECTABLE CABOTEGRAVIR FOR HIV PREVENTION: HPTN 083
Marzinke, Mark A. et al. | Date Issued: 2021
Author
Marzinke, Mark A.
Grinsztejn, Beatriz
Fogel, Jessica M.
Piwowar-Manning, Estelle
Li, Maoji
Weng, Lei
McCauley, Marybeth
Cummings, Vanessa
Ahmed, Shahnaz
Haines, Casey D.
Bushman, Lane R.
Petropoulos, Christos
Persaud, Deborah
Adeyeye, Adeola
Kofron, Ryan
Rinehart, Alex
St Clair, Marty
Rooney, James F.
Pryluka, Daniel
Coelho, Lara
Gaur, Aditya
Middelkoop, Keren
Phanuphak, Nittaya
Cohen, Myron S.
Hendrix, Craig W.
Anderson, Peter
Hanscom, Brett
Donnell, Deborah
Landovitz, Raphael J.
Eshleman, Susan H.
Affilliation
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA / Johns Hopkins University School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
FHI 360. Durham, North Carolina, USA.
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
University of Colorado. Aurora, Colorado, USA.
Monogram Biosciences. South San Francisco, California, USA.
Johns Hopkins University School of Medicine. Department of Pediatrics. Baltimore, Maryland, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Division of AIDS. Prevention Science Program. Rockville, Maryland, USA.
University of California at Los Angeles. Department of Medicine. Los Angeles, California, USA.
ViiV Healthcare. Research Triangle Park, North Carolina, USA.
ViiV Healthcare. Research Triangle Park, North Carolina, USA.
Gilead Sciences. Foster City, California, USA.
Hospital Velez Sarfield. Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
St Jude Children's Research Hospital. Memphis, Tennessee, USA.
University of Cape Town. Institute of Infectious Disease and Molecular Medicine. Desmond Tutu HIV Centre. Cape Town, South Africa.
Institute of HIV Research and Innovation. Bangkok, Thailand / Chulalongkorn University. Center of Excellence in Transgender Health. Bangkok, Thailand.
University of North Carolina. Department of Medicine. North Carolina, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
University of Colorado. Aurora, Colorado, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
University of California. Center for Clinical AIDS Research & Education. Los Angeles, California, USA.
Johns Hopkins University School of Pathology. Department of Pathology. Baltimore, Maryland, USA.
Abstract
Background: The HIV Prevention Trials Network (HPTN) 083 trial demonstrated that long-acting cabotegravir (CAB-LA) was more effective than tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) in preventing human immunodeficiency virus (HIV) in cisgender men and transgender women who have sex with men. We characterized HIV infections that occurred in the blinded phase of HPTN 083. Methods: Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing. Results: Fifty-eight infections were evaluated, including 51 incident infections (12 in CAB arm and 39 in TDF/FTC arm). In many cases (5 in CAB arm and 37 in TDF/FTC arm), infection was associated with low or unquantifiable study drug concentrations. In 4 cases, infection occurred with on-time CAB-LA injections and expected plasma CAB concentrations. CAB exposure was associated with prolonged viral suppression and delayed antibody expression. In some cases, delayed HIV diagnosis resulted in CAB provision to participants with undetected infection, delayed antiretroviral therapy, and emergence of drug resistance; most of these infections would have been detected earlier with viral load testing. Conclusions: Early detection of HIV infection and prompt antiretroviral therapy initiation could improve clinical outcomes in persons who become infected despite CAB-LA prophylaxis. Further studies are needed to elucidate the correlates of HIV protection in persons receiving CAB-LA.
Keywords
HIV
HPTN 083
TDF/FTC
Cabotegravir
Injectable
Long-acting
Men who have sex with men
Preexposure prophylaxis
Prevention
 
Publisher
Oxford
Citation
MARZINKE, Mark A. et al. Characterization of Human Immunodeficiency Virus (HIV) Infection in Cisgender Men and Transgender Women Who Have Sex With Men Receiving Injectable Cabotegravir for HIV Prevention: HPTN 083. The Journal of Infectious Diseases, v. 224, n. 9, p. 1581-1592, Nov. 2021.
DOI
10.1093/infdis/jiab152
ISSN
0022-1899