biostudies-literatureMarzinke MANational Institute of Allergy and Infectious DiseasesNIAID NIH HHSNational Institute of Mental HealthNational Institutes of HealthNational Institute on Drug Abuse1581-1592https://www.ebi.ac.uk/biostudies/studies/S-EPMC8599849biostudies-literatureUnknown224(9)<h4>Background</h4>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.<h4>Methods</h4>Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing.<h4>Results</h4>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.<h4>Conclusions</h4>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 Journal of infectious diseasesCharacterization 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.PMC8599849UM1 AI069424UM1AI068619UM1 AI068613UM1AI068617UM1 AI069536UM1 AI068617UM1AI068613UM1 AI068619U01 AI069476UM1 AI069476Landovitz RJAhmed SMarzinke MADonnell DGaur APiwowar-Manning EMiddelkoop KAdeyeye AFogel JMGrinsztejn BRinehart ACoelho LPhanuphak NCohen MSSt Clair MEshleman SHHanscom BWeng LCummings VMcCauley MHaines CDLi MRooney JFPryluka DPersaud DKofron RPetropoulos CAnderson PHendrix CWBushman LRfalseCharacterization 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.<h4>Background</h4>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.<h4>Methods</h4>Retrospective testing included HIV testing, viral load testing, quantification of study drugs, and HIV drug resistance testing.<h4>Results</h4>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.<h4>Conclusions</h4>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.2021-01-01T00:00:00Z2021 Nov2025-04-22T10:01:55.43Z2025-04-05T23:22:46.246ZS-EPMC85998493374005710.1093/infdis/jiab152