{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:10:46Z","timestamp":1787019046299,"version":"build-2736575974"},"reference-count":22,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T00:00:00Z","timestamp":1761177600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To review the efficacy and safety of lenacapavir for the prevention of HIV-1 infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>Clinical trials and review articles were obtained through August 2025 using search terms lenacapavir, GS-CA1, GS-6207, capsid inhibitor, preexposure prophylaxis, and PrEP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>All relevant articles, trials, and abstracts in the English language were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Lenacapavir uses a novel mechanism for HIV prevention administered through subcutaneous injection. In a counterfactual design, lenacapavir arms demonstrated superior efficacy for prevention against a background HIV incidence rate across a variety of populations and gender identities. Adverse events commonly reported include injection-site reactions, which may include nodules, pain, or swelling at the injection site.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:<\/jats:title>\n                    <jats:p>The extended dosing frequency of lenacapavir may uniquely serve patients at risk of HIV acquisition who are unable or unwilling to take oral prevention medications. The mechanism of action for lenacapavir is not duplicative of other medications used in first-line antiretroviral regimens and thus may not risk resistance to regularly used classes if resistance occurs. Lenacapavir is a moderate cytochrome P450 inhibitor and thus may have interactions with other medications; however, neither renal nor hepatic dose adjustments are required.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Lenacapavir provides a long-acting injectable option for people seeking a pharmacologic prevention agent against HIV-1. Despite injection-site reactions being relatively common, these did not present a barrier to treatment continuation among trial participants.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280251379877","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T07:11:47Z","timestamp":1761203507000},"page":"276-286","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Lenacapavir: A Twice-Yearly Injectable for HIV Preexposure Prophylaxis"],"prefix":"10.1177","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6601-9893","authenticated-orcid":false,"given":"David E.","family":"Koren","sequence":"first","affiliation":[{"name":"Department of Pharmacy Services, Temple University Health System, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1775-9497","authenticated-orcid":false,"given":"Elias B.","family":"Chahine","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6559-0684","authenticated-orcid":false,"given":"Elizabeth M.","family":"Sherman","sequence":"additional","affiliation":[{"name":"Nova Southeastern University, Fort Lauderdale, FL, USA"},{"name":"Memorial Healthcare System, Hollywood, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,10,23]]},"reference":[{"key":"e_1_3_2_2_2","unstructured":"Apretude (cabotegravir) [package insert]. Durham NC: ViiV Healthcare September 2024."},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/10600280231171375"},{"key":"e_1_3_2_4_2","unstructured":"Yeztugo (lenacapavir) [package insert]. Foster City CA: Gilead Sciences June 2025."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-020-2443-1"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.01344-23"},{"key":"e_1_3_2_7_2","volume-title":"Paper presented at: AIDS 2022; 29 July-2 August","author":"Jogiraju V","year":"2022","unstructured":"Jogiraju V, Graham H, West S, et al. Pharmacokinetics of a simplified subcutaneous lenacapavir regimen versus phase 2\/3 regimen [Poster PESUB22]. Paper presented at: AIDS 2022; 29 July-2 August, 2022; Montreal, QC, Canada."},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-021-04279-4"},{"key":"e_1_3_2_9_2","unstructured":"Bekerman E Hansen Lu B et al. Long-acting capsid inhibitor effective as PrEP against vaginal SHIV transmission in macaques. Abstract PECLB24 presented at IAS2021 18-21 July Berlin."},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2023.104764"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2407001"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2411858"},{"key":"e_1_3_2_13_2","unstructured":"Kiweewa FM Ahmed K Nair G et al. Adherence to F\/TAF in cisgender women prevents HIV with low risk of resistance or diagnostic delay. Abstract 194 presented at CROI2025 9-12 March San Francisco CA."},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2402088"},{"key":"e_1_3_2_15_2","unstructured":"Panel on Antiretroviral Guidelines for Adults Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Accessed June 20 2025. https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/adult-and-adolescent-arv"},{"key":"e_1_3_2_16_2","unstructured":"Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. Department of Health and Human Services. Accessed June 20 2025. https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/perinatal"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.11410"},{"key":"e_1_3_2_18_2","unstructured":"Lenacapavir. Lexi-drugs. UpToDate Lexidrug. UpToDate Inc. Accessed August 20 2025. https:\/\/online.lexi.com"},{"key":"e_1_3_2_19_2","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Cost considerations and antiretroviral therapy. In: guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Year. Accessed June 20 2025. https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/adult-adolescent-arv\/antiretroviral-therapy-cost-considerations-adult-adolescent-arv.pdf"},{"key":"e_1_3_2_20_2","unstructured":"NASTAD. Long-Acting Injectable Injectable PrEP. Accessed June 20 2025. https:\/\/nastad.org\/long-acting-injectable-prep"},{"key":"e_1_3_2_21_2","unstructured":"Gilead Sciences. Gilead signs royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in high-incidence resource-limited countries. Accessed 20 June 2025. https:\/\/www.gilead.com\/news\/news-details\/2024\/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","unstructured":"Choopanya K Martin M Suntharasamai P et al. 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