{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T02:03:20Z","timestamp":1793239400805,"version":"4.5.0"},"reference-count":178,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T00:00:00Z","timestamp":1787616000000},"content-version":"vor","delay-in-days":24,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01AI170295"],"award-info":[{"award-number":["R01AI170295"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000027","name":"National Institute on Alcohol Abuse and Alcoholism","doi-asserted-by":"publisher","award":["R01AA030483"],"award-info":[{"award-number":["R01AA030483"]}],"id":[{"id":"10.13039\/100000027","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Long\u2010acting (LA) antiretroviral (ARV) medications represent a significant advancement in the HIV treatment and prevention field. LA ARVs help reduce daily pill burden and thus optimize adherence, which has translated into sustained virologic suppression in persons with HIV, prevention of HIV transmission among those at risk, and improved patient satisfaction. This review examines the clinical pharmacology considerations, clinical trials, and real\u2010world use of small molecule LA injectable ARVs, specifically cabotegravir, rilpivirine, and lenacapavir, in adults with or at risk of acquiring HIV, with a particular focus on the pharmacokinetic data and considerations with these agents as implementation expands. Special attention is also paid to understudied populations such as pediatrics and pregnant and breastfeeding women. Discussion of the underlying pharmacokinetics is provided to highlight considerations regarding time to onset of protection, handling residual concentrations and the potential for the development of resistance with treatment discontinuation, factors contributing to variability in drug exposure and relationships between exposure and efficacy. Despite the promise that these LA injectable ARVs hold, there are still opportunities for further investigation to optimize patient care, and these considerations are also covered.<\/jats:p>","DOI":"10.1002\/jcph.70249","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T12:06:55Z","timestamp":1787659615000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Long\u2010Acting Injectable Antiretroviral Therapies for HIV Treatment and Prevention: Clinical Pharmacology, Recent Advances and Future Opportunities"],"prefix":"10.1002","volume":"66","author":[{"given":"Alexandra","family":"Dunbar","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2246-4581","authenticated-orcid":false,"given":"Natella","family":"Rakhmanina","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases Children's National Hospital  Washington DC USA"},{"name":"School of Medicine and Health Sciences The George Washington University  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1669-6455","authenticated-orcid":false,"given":"Justin","family":"Unternaher","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases Children's National Hospital  Washington DC USA"},{"name":"Great Ormond Street Institute of Child Health University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter L.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3832-8699","authenticated-orcid":false,"given":"Kristina M.","family":"Brooks","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,25]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV","author":"Panel on Antiretroviral Guidelines for Adults and Adolescents","year":"2026"},{"issue":"7","key":"e_1_2_11_3_1","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1001\/jama.2024.24543","article-title":"Antiretroviral drugs for treatment and prevention of HIV in adults: 2024 recommendations of the International Antiviral Society\u2010USA Panel","volume":"333","author":"Gandhi RT","year":"2025","journal-title":"JAMA, J Am Med Assoc"},{"issue":"9","key":"e_1_2_11_4_1","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1038\/nrd1494","article-title":"Nanosuspensions in drug delivery","volume":"3","author":"Rabinow BE","year":"2004","journal-title":"Nat Rev Drug Discov"},{"key":"e_1_2_11_5_1","volume-title":"Apretude (Cabotegravir Extended\u2010Release Injectable Suspension), for Intramuscular Use","author":"Prescribing Information","year":"2025"},{"key":"e_1_2_11_6_1","volume-title":"Cabenuva (Cabotegravir and Rilpivirine) Extended\u2010Release Injectable Suspension and Tablets: Prescribing Information","author":"ViiV Healthcare","year":"2023"},{"key":"e_1_2_11_7_1","volume-title":"Yeztugo (Lenacapavir). 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failure with cabotegravir\/rilpivirine","volume":"79","author":"Bail\u00f3n L","year":"2024","journal-title":"J Antimicrob Chemoth"},{"issue":"1","key":"e_1_2_11_116_1","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1007\/s11904-025-00743-2","article-title":"A guide to the evolving clinical landscape of low\u2010level viremia among persons with HIV in the modern treatment era","volume":"22","author":"Aldredge A","year":"2025","journal-title":"Curr HIV\/AIDS Rep"},{"issue":"10","key":"e_1_2_11_117_1","doi-asserted-by":"crossref","DOI":"10.1002\/jmv.29178","article-title":"Integrated analysis of viral blips, residual viremia, and associated factors in people with HIV: Results from a retrospective cohort study","volume":"95","author":"Oomen PGA","year":"2023","journal-title":"J Med Virol"},{"issue":"1","key":"e_1_2_11_118_1","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1097\/QAI.0000000000003320","article-title":"Predictors of post\u2010switch viremia in people with 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