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 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 chara...

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Veröffentlicht in:The Journal of infectious diseases Jg. 224; H. 9; S. 1581
Hauptverfasser: 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
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 16.11.2021
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ISSN:1537-6613, 1537-6613
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Abstract 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. Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing. 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. 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.
AbstractList 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. Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing. 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. 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.
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.BACKGROUNDThe 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.Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing.METHODSRetrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing.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.RESULTSFifty-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.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.CONCLUSIONSEarly 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.
Author Landovitz, Raphael J
Bushman, Lane R
Pryluka, Daniel
Anderson, Peter
Marzinke, Mark A
Middelkoop, Keren
Hendrix, Craig W
Li, Maoji
St Clair, Marty
Eshleman, Susan H
Gaur, Aditya
Haines, Casey D
Persaud, Deborah
Rooney, James F
Petropoulos, Christos
Donnell, Deborah
Rinehart, Alex
McCauley, Marybeth
Fogel, Jessica M
Piwowar-Manning, Estelle
Phanuphak, Nittaya
Weng, Lei
Hanscom, Brett
Cohen, Myron S
Ahmed, Shahnaz
Kofron, Ryan
Coelho, Lara
Grinsztejn, Beatriz
Adeyeye, Adeola
Cummings, Vanessa
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Copyright The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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Issue 9
Keywords injectable
HIV
preexposure prophylaxis
HPTN 083
TDF/FTC
cabotegravir
long-acting
men who have sex with men
prevention
Language English
License The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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PublicationDecade 2020
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PublicationTitle The Journal of infectious diseases
PublicationTitleAlternate J Infect Dis
PublicationYear 2021
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Snippet The HIV Prevention Trials Network (HPTN) 083 trial demonstrated that long-acting cabotegravir (CAB-LA) was more effective than tenofovir disoproxil...
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StartPage 1581
SubjectTerms Adolescent
Adult
Anti-HIV Agents - administration & dosage
Diketopiperazines - administration & dosage
Female
HIV Infections - epidemiology
HIV Infections - prevention & control
HIV Integrase Inhibitors - administration & dosage
Homosexuality, Male
Humans
Incidence
Male
Middle Aged
Pre-Exposure Prophylaxis
Pyridones - administration & dosage
Retrospective Studies
Transgender Persons
Viral Load - drug effects
Title 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
URI https://www.ncbi.nlm.nih.gov/pubmed/33740057
https://www.proquest.com/docview/2503445263
Volume 224
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