{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T23:40:51Z","timestamp":1787701251901,"version":"build-2784847793"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000179","name":"Office of the Director","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000179","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000026","name":"National Institute on Drug Abuse","doi-asserted-by":"publisher","award":["UM1AI068619"],"award-info":[{"award-number":["UM1AI068619"]}],"id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100029382","name":"HIV Prevention Trials Network [HPTN] Leadership and Operations Center","doi-asserted-by":"publisher","award":["UM1AI068617"],"award-info":[{"award-number":["UM1AI068617"]}],"id":[{"id":"10.13039\/100029382","id-type":"DOI","asserted-by":"publisher"}]},{"name":"HPTN Statistical and Data Management Center","award":["UM1AI068613"],"award-info":[{"award-number":["UM1AI068613"]}]},{"name":"HPTN Laboratory Center"},{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The HIV Prevention Trials Network (HPTN) 083 Trial demonstrated the superiority of long-acting, injectable cabotegravir (CAB) over daily oral tenofovir disoproxil fumarate\/emtricitabine (TDF\/FTC) for HIV pre-exposure prophylaxis among cisgender men (MSM) and transgender women (TGW) who have sex with men. Plasma CAB concentrations associated with HIV protection in humans are unknown.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a nested case-control study to investigate the association between plasma CAB concentrations and HIV risk. Plasma CAB concentrations were estimated for participants with confirmed HIV and for HIV-negative controls, who were matched on region, gender, and race. The window of HIV acquisition for cases was defined as the time between the last HIV-negative visit and the first HIV-positive visit; this window was used to evaluate CAB exposure for cases and their matched controls. Participants were categorized by the minimum estimated CAB concentration (CABmin) during this window relative to the protein-adjusted 90% CAB inhibitory concentration (1\u00d7 PA-IC90) and 4\u00d7 PA-IC90. HIV risk was modeled using conditional logistic regression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Plasma CABmin was \u22654\u00d7 PA-IC90 in 26% of HIV-positive cases, compared with 76% of matched controls. Plasma CABmin \u22654\u00d7 PA-IC90 was associated with a 93% reduction in risk of HIV acquisition compared with CABmin &amp;lt;1\u00d7 PA-IC90 (95% CI: 76%, 98%, P &amp;lt; .001). CABmin between 1\u00d7 and 4\u00d7 PA-IC90 had an estimated risk reduction of 79% compared with CABmin &amp;lt;1\u00d7 PA-IC90 (95% CI: \u221219%, 96%, P = .07).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Consistent plasma CAB concentrations \u22654\u00d7 PA-IC90 were estimated to provide 93% protection against HIV in MSM and TGW.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiaf561","type":"journal-article","created":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T00:29:10Z","timestamp":1762648150000},"page":"e454-e461","source":"Crossref","is-referenced-by-count":4,"title":["Estimation of Prevention-Effective CAB-LA Concentrations Among Men Who Have Sex With Men (MSM) and Transgender Women (TGW) in HPTN 083"],"prefix":"10.1093","volume":"233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0618-2979","authenticated-orcid":false,"given":"Brett","family":"Hanscom","sequence":"first","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutch Cancer Center , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A","family":"Marzinke","sequence":"additional","affiliation":[{"name":"John Hopkins School of Medicine, John Hopkins University , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3002-4146","authenticated-orcid":false,"given":"Xinnong","family":"Li","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, University of Buffalo , Buffalo, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0587-7480","authenticated-orcid":false,"given":"Deborah","family":"Donnell","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutch Cancer Center , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3818-2252","authenticated-orcid":false,"given":"Robert","family":"Bies","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, University of Buffalo , Buffalo, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5696-8665","authenticated-orcid":false,"given":"Craig W","family":"Hendrix","sequence":"additional","affiliation":[{"name":"John Hopkins School of Medicine, John Hopkins University , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhe","family":"Wang","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division, Fred Hutch Cancer Center , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7672-3818","authenticated-orcid":false,"given":"Carolina","family":"Acuipil","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Rinehart","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon W","family":"Collins","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Durham, North Carolina 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Chang Mai University , Chang Mai ,","place":["Thailand"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Valdez Ramalho Madruga","sequence":"additional","affiliation":[{"name":"Secretarial of Health , Sao Paulo ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3290-8200","authenticated-orcid":false,"given":"Christopher B","family":"Hurt","sequence":"additional","affiliation":[{"name":"Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6359-987X","authenticated-orcid":false,"given":"Manya","family":"Magnus","sequence":"additional","affiliation":[{"name":"Milken Institute School of Public Health, George Washington University , Washington DC 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long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial","volume":"10","author":"Landovitz","year":"2023","journal-title":"Lancet HIV"},{"key":"2026031304544750500_jiaf561-B4","doi-asserted-by":"crossref","first-page":"1151","DOI":"10.1126\/science.1248707","article-title":"Long-acting integrase inhibitor protects macaques from intrarectal simian\/human immunodeficiency virus","volume":"343","author":"Andrews","year":"2014","journal-title":"Science"},{"key":"2026031304544750500_jiaf561-B5","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1310\/hct1405-192","article-title":"Pharmacokinetics, safety, and monotherapy antiviral activity of GSK1265744, an HIV integrase strand transfer inhibitor","volume":"14","author":"Spreen","year":"2013","journal-title":"HIV Clin Trials"},{"key":"2026031304544750500_jiaf561-B6"},{"key":"2026031304544750500_jiaf561-B7","doi-asserted-by":"crossref","first-page":"1581","DOI":"10.1093\/infdis\/jiab152","article-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","volume":"224","author":"Marzinke","year":"2021","journal-title":"J Infect Dis"},{"key":"2026031304544750500_jiaf561-B8","doi-asserted-by":"crossref","first-page":"e0005323","DOI":"10.1128\/aac.00053-23","article-title":"Extended analysis of HIV infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083","volume":"67","author":"Marzinke","year":"2023","journal-title":"Antimicrob Agents Chemother"},{"key":"2026031304544750500_jiaf561-B9","doi-asserted-by":"crossref","first-page":"4607","DOI":"10.1111\/bcp.15439","article-title":"Population pharmacokinetics of cabotegravir following administration of oral tablet and long-acting intramuscular injection in adult HIV-1-infected and uninfected subjects","volume":"88","author":"Han","year":"2022","journal-title":"Br J Clin Pharmacol"},{"key":"2026031304544750500_jiaf561-B10","doi-asserted-by":"crossref","first-page":"e703","DOI":"10.1016\/S2352-3018(23)00200-X","article-title":"Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial","volume":"10","author":"Marzinke","year":"2023","journal-title":"Lancet HIV"},{"key":"2026031304544750500_jiaf561-B11","doi-asserted-by":"crossref","first-page":"e472","DOI":"10.1016\/S2352-3018(20)30106-5","article-title":"Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial","volume":"7","author":"Landovitz","year":"2020","journal-title":"Lancet HIV"},{"key":"2026031304544750500_jiaf561-B12"},{"key":"2026031304544750500_jiaf561-B13","doi-asserted-by":"crossref","first-page":"1253","DOI":"10.1056\/NEJMc2402088","article-title":"Features of HIV infection in long-acting cabotegravir Pre-exposure prophylaxis","volume":"391","author":"Landovitz","year":"2024","journal-title":"N Engl J Med"},{"key":"2026031304544750500_jiaf561-B14","volume-title":"R: a language and environment for statistical computing","author":"R Core Team","year":"2021"},{"key":"2026031304544750500_jiaf561-B15","doi-asserted-by":"crossref","first-page":"151ra125","DOI":"10.1126\/scitranslmed.3004006","article-title":"Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men","volume":"4","author":"Anderson","year":"2012","journal-title":"Sci Transl Med"},{"key":"2026031304544750500_jiaf561-B16","doi-asserted-by":"crossref","first-page":"820","DOI":"10.1016\/S1473-3099(14)70847-3","article-title":"Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study","volume":"14","author":"Grant","year":"2014","journal-title":"Lancet Infect Dis"},{"key":"2026031304544750500_jiaf561-B17","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1097\/QAI.0000000000000301","article-title":"GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects","volume":"67","author":"Spreen","year":"2014","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2026031304544750500_jiaf561-B18","doi-asserted-by":"crossref","first-page":"e0099424","DOI":"10.1128\/aac.00994-24","article-title":"Pharmacologic evaluation of delayed long-acting cabotegravir administration among cisgender women in HPTN 084","volume":"68","author":"Marzinke","year":"2024","journal-title":"Antimicrob Agents Chemother"},{"key":"2026031304544750500_jiaf561-B19","doi-asserted-by":"crossref","first-page":"4623","DOI":"10.1111\/bcp.15477","article-title":"A population pharmacokinetic model based on HPTN 077 of long-acting injectable cabotegravir for HIV PrEP","volume":"88","author":"Yu","year":"2022","journal-title":"Br J Clin Pharmacol"},{"key":"2026031304544750500_jiaf561-B20","doi-asserted-by":"crossref","first-page":"1667","DOI":"10.1111\/bcp.14980","article-title":"Multicompartmental pharmacokinetic evaluation of long-acting cabotegravir in healthy adults for HIV preexposure prophylaxis","volume":"88","author":"Shaik","year":"2022","journal-title":"Br J Clin Pharmacol"},{"key":"2026031304544750500_jiaf561-B21","doi-asserted-by":"crossref","first-page":"1124","DOI":"10.1056\/NEJMoa1909512","article-title":"Long-acting cabotegravir and 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