{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T21:36:24Z","timestamp":1793223384881,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T00:00:00Z","timestamp":1724889600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc","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":[[2025,3,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Lenacapavir is a long-acting human immunodeficiency virus type 1 (HIV-1) capsid inhibitor for treatment of HIV-1 infection. We evaluated the efficacy and safety of lenacapavir in combination with an investigator-selected optimized background regimen (OBR) after 104 weeks in adults with multidrug-resistant HIV-1.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This ongoing, international, Phase 2\/3 trial at 42 sites included 72 adults with multidrug-resistant HIV-1. Following a 2-week oral lenacapavir loading phase, participants received subcutaneous lenacapavir every 26 weeks with an OBR. HIV-1 RNA, CD4 cell counts, and adverse events were assessed over 104 weeks. One participant did not enter the extension phase.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>At Week 104, 44 of 71 participants (62%, 95% confidence interval [CI]: 50; 73) had HIV-1 RNA &amp;lt;50 copies\/mL via US Food and Drug Administration (FDA) snapshot algorithm. When missing data (including discontinuations) were excluded, 44 of 54 participants (82%) had HIV-1 RNA &amp;lt;50 copies\/mL at Week 104, mean CD4 cell count increased by 122 cells\/\u00b5L (95% CI: 80; 165), and the proportion of participants with CD4 cell count &amp;lt;200 cells\/\u00b5L decreased from 64% (46 of 72) at Baseline to 29% (16 of 55). Fourteen participants had treatment-emergent lenacapavir resistance; 7 resuppressed (HIV-1 RNA &amp;lt;50 copies\/mL) while maintaining lenacapavir use. There were no Grade 4 or serious treatment-related adverse events. One participant discontinued study drug due to an injection site reaction.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Treatment with subcutaneous lenacapavir in combination with an OBR was well tolerated and resulted in a high rate of virological suppression over 104 weeks. Lenacapavir represents an important treatment option in people with multidrug-resistant HIV-1.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciae423","type":"journal-article","created":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T23:55:39Z","timestamp":1724889339000},"page":"566-574","source":"Crossref","is-referenced-by-count":44,"title":["Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2\/3 Trial"],"prefix":"10.1093","volume":"80","author":[{"given":"Onyema","family":"Ogbuagu","sequence":"first","affiliation":[{"name":"Yale School of Medicine , New Haven, Connecticut ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Michel","family":"Molina","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris Cit\u00e9 , Paris ,","place":["France"]},{"name":"D\u00e9partement de Maladies Infectieuses, H\u00f4pitaux Saint- Louis, Lariboisi\u00e8re, Assistance Publique H\u00f4pitaux de Paris , Paris ,","place":["France"]},{"name":"INSERM UMR 944 , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ploenchan","family":"Chetchotisakd","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen University , Khon Kaen ,","place":["Thailand"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moti N","family":"Ramgopal","sequence":"additional","affiliation":[{"name":"Midway Immunology & Research Center , Fort Pierce, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Sanchez","sequence":"additional","affiliation":[{"name":"Floridian Clinical Research , Miami Lakes, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Brunetta","sequence":"additional","affiliation":[{"name":"Maple Leaf Medical Clinic , Toronto, Ontario ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Castelli","sequence":"additional","affiliation":[{"name":"Unit of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili Hospital , Brescia ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordon E","family":"Crofoot","sequence":"additional","affiliation":[{"name":"The Crofoot Research Center , Houston, Texas ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chien-Ching","family":"Hung","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine , Taipei ,","place":["Taiwan"]},{"name":"Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine , Taipei ,","place":["Taiwan"]},{"name":"Department of Internal Medicine, National Taiwan University Hospital Yunlin Branch , Yunlin ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Ronot-Bregigeon","sequence":"additional","affiliation":[{"name":"AP-HM H\u00f4pital Sainte Marguerite, Service Immuno-H\u00e9matologie Clinique , Marseille ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas A","family":"Margot","sequence":"additional","affiliation":[{"name":"Gilead Sciences , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[{"name":"Gilead Sciences , Foster City, California 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