{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T21:36:28Z","timestamp":1793223388947,"version":"4.5.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"14","license":[{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,10,22]],"date-time":"2022-10-22T00:00:00Z","timestamp":1666396800000},"content-version":"vor","delay-in-days":51,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Lenacapavir (Sunlenca\n                    <jats:sup>\u00ae<\/jats:sup>\n                    ) is a long-acting capsid inhibitor of human immunodeficiency virus type\u00a01 (HIV-1) being developed by Gilead Sciences Inc. It is available as an oral tablet and injectable solution, with the latter being a slow-release formulation to allow bi-annual subcutaneous administration. In August 2022, lenacapavir received its first approval in the EU for use in combination with other antiretroviral(s) in adults with multi-drug resistant HIV infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. This article summarizes the milestones in the development of lenacapavir leading to this first approval for the treatment of HIV-1 infection.\n                  <\/jats:p>","DOI":"10.1007\/s40265-022-01786-0","type":"journal-article","created":{"date-parts":[[2022,10,22]],"date-time":"2022-10-22T05:11:22Z","timestamp":1666415482000},"page":"1499-1504","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":91,"title":["Lenacapavir: First Approval"],"prefix":"10.1007","volume":"82","author":[{"given":"Julia","family":"Paik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,10,22]]},"reference":[{"issue":"5","key":"1786_CR1","doi-asserted-by":"publisher","first-page":"393","DOI":"10.3851\/IMP3121","volume":"22","author":"S Teeraananchai","year":"2017","unstructured":"Teeraananchai S, Chaivooth S, Kerr SJ, et al. Life expectancy after initiation of combination antiretroviral therapy in Thailand. Antivir Ther. 2017;22(5):393\u2013402.","journal-title":"Antivir Ther"},{"issue":"1","key":"1786_CR2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0245185","volume":"16","author":"KS Oh","year":"2021","unstructured":"Oh KS, Han E. A comparison of medication adherence and viral suppression in antiretroviral treatment-naive patients with HIV\/AIDS depending on the drug formulary. PLoS ONE. 2021;16(1): e0245185.","journal-title":"PLoS ONE"},{"issue":"11","key":"1786_CR3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002183","volume":"13","author":"Z Shubber","year":"2016","unstructured":"Shubber Z, Mills EJ, Nachega JB, et al. Patient-reported barriers to adherence to antiretroviral therapy: a systematic review and meta-analysis. PLoS Med. 2016;13(11): e1002183.","journal-title":"PLoS Med"},{"key":"1786_CR4","unstructured":"Gilead Sciences Inc. Lenacapavir (Sunlenca\u00ae): EU summary of product characteristics. 2022. https:\/\/ema.europa.eu\/. Accessed 21 Sep 2022."},{"key":"1786_CR5","unstructured":"Gilead Sciences Inc. Gilead announces first regulatory approval for Sunlenca\u00ae (lenacapavir), the only twice-yearly HIV treatment option [media release]. 22 Aug 2022. https:\/\/www.gilead.com\/."},{"key":"1786_CR6","unstructured":"Gilead S. Gilead and Merck announce agreement to jointly develop and commercialize long-acting, investigational treatment combinations of lenacapavir and islatravir in HIV [media release]. 15 Mar 2021. http:\/\/www.gilead.com."},{"issue":"6514","key":"1786_CR7","doi-asserted-by":"publisher","first-page":"360","DOI":"10.1126\/science.abb4808","volume":"370","author":"SM Bester","year":"2020","unstructured":"Bester SM, Wei G, Zhao H, et al. Structural and mechanistic bases for a potent HIV-1 capsid inhibitor. Science. 2020;370(6514):360\u20134.","journal-title":"Science"},{"issue":"7822","key":"1786_CR8","doi-asserted-by":"publisher","first-page":"614","DOI":"10.1038\/s41586-020-2443-1","volume":"584","author":"JO Link","year":"2020","unstructured":"Link JO, Rhee MS, Tse WC, et al. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020;584(7822):614\u20138.","journal-title":"Nature"},{"key":"1786_CR9","unstructured":"Callebaut C, VanderVeen L, Margot N. Activity and resistance characterization of the HIV capsid inhibitor lenacapavir [abstract no. 128]. In: 28th Conference on Retroviruses and Opportunistic Infections. 2021."},{"issue":"19","key":"1786_CR10","doi-asserted-by":"publisher","first-page":"1793","DOI":"10.1056\/NEJMoa2115542","volume":"386","author":"S Segal-Maurer","year":"2022","unstructured":"Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. N Engl J Med. 2022;386(19):1793\u2013803.","journal-title":"N Engl J Med"},{"key":"1786_CR11","unstructured":"Gupta S, Sims J, Brinson C, et al. Lenacapavir as part of a combination regimen in treatment-naive people with HIV: week 54 results [abstract no. 138 plus oral presentation]. In: 29th Conference on Retroviruses and Opportunistic Infections. 2002."},{"issue":"3","key":"1786_CR12","doi-asserted-by":"publisher","first-page":"e02057","DOI":"10.1128\/AAC.02057-20","volume":"65","author":"N Margot","year":"2021","unstructured":"Margot N, Ram R, Rhee M, et al. Absence of lenacapavir (GS-6207) phenotypic resistance in HIV Gag cleavage site mutants and in isolates with resistance to existing drug classes. Antimicrob Agents Chemother. 2021;65(3):e02057-e2120.","journal-title":"Antimicrob Agents Chemother"},{"key":"1786_CR13","unstructured":"Margot N, Naik V, VanderVeen L. Absence of cross-resistance to lenacapavir in HIV entry inhibitor-resistant isolates [abstract no. 508]. In: 29th Conference on Retroviruses and Opportunistic Infections. 2022."},{"issue":"6","key":"1786_CR14","doi-asserted-by":"publisher","first-page":"1202","DOI":"10.3390\/v14061202","volume":"14","author":"ME Cilento","year":"2022","unstructured":"Cilento ME, Ong YT, Tedbury PR, et al. Drug interactions in lenacapavir-based long-acting antiviral combinations. Viruses. 2022;14(6):1202.","journal-title":"Viruses"},{"key":"1786_CR15","unstructured":"Weber E, Graham H, West S, et al. Pharmacokinetics of lenacapavir in participants with severe renal impairment [abstract no. 434]. In: 29th Conference on Retroviruses and Opportunistic Infections. 2022."},{"key":"1786_CR16","unstructured":"Jogiraju V, Begley R, Hindman J, et al. Pharmacokinetics of lenacapavir, an HIV-1 capsid inhibitor, in hepatic impairment [abstract no. 375]. In: 28th Conference on Retroviruses and Opportunistic Infections. 2021."},{"issue":"S2","key":"1786_CR17","first-page":"26","volume":"23","author":"O Ogbuagu","year":"2022","unstructured":"Ogbuagu O, Segal-Maurer S, Brinson C, et al. Long-acting lenacapavir in people with multi-drug resistant HIV-1: week 52 results [abstract no. P006]. HIV Med. 2022;23(S2):26\u20137.","journal-title":"HIV Med"},{"key":"1786_CR18","first-page":"125","volume":"22","author":"HJ Stellbrink","year":"2021","unstructured":"Stellbrink HJ, DeJesus E, Segal-Maurer S, et al. Subgroup efficacy analyses of long-acting subcutaneous lenacapavir in phase 2\/3 in heavily treatment-experienced people with HIV (CAPELLA study). HIV Med. 2021;22:125\u20136.","journal-title":"HIV Med"},{"key":"1786_CR19","first-page":"13","volume":"24","author":"SK Gupta","year":"2021","unstructured":"Gupta SK, Berhe M, Crofoot G, et al. Long-acting subcutaneous lenacapavir dosed every six months as part of a combination regimen in treatment-naive people with HIV: interim 16-week results of a randomized, open-label, phase 2 induction-maintenance study (CALIBRATE) [abstract no. OALB0302 plus presentation]. J Int AIDS Soc. 2021;24:13.","journal-title":"J Int AIDS Soc"}],"updated-by":[{"DOI":"10.1007\/s40265-023-01908-2","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2023,6,14]],"date-time":"2023-06-14T00:00:00Z","timestamp":1686700800000}}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-022-01786-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-022-01786-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-022-01786-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,15]],"date-time":"2023-06-15T02:22:09Z","timestamp":1686795729000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-022-01786-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9]]},"references-count":19,"journal-issue":{"issue":"14","published-print":{"date-parts":[[2022,9]]}},"alternative-id":["1786"],"URL":"https:\/\/doi.org\/10.1007\/s40265-022-01786-0","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9]]},"assertion":[{"value":"22 October 2022","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 June 2023","order":2,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":3,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":4,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s40265-023-01908-2","URL":"https:\/\/doi.org\/10.1007\/s40265-023-01908-2","order":5,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Julia Paik is a salaried employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}