{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T12:57:15Z","timestamp":1793969835565,"version":"4.8.0"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T00:00:00Z","timestamp":1766102400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Lenacapavir is a twice-yearly HIV-1 capsid inhibitor approved, in combination with other antiretrovirals, for the treatment of heavily treatment-experienced people with multidrug-resistant HIV, based on the Phase 2\/3 CAPELLA study. Here, we report week 156 efficacy and safety results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In CAPELLA (NCT04150068), participants received 2-week oral lenacapavir lead-in doses, followed by subcutaneous lenacapavir every 6 months, combined with an investigator-selected optimized background regimen. Endpoints included virologic outcomes, CD4 cell count trends, adverse events, and treatment-emergent resistance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>CAPELLA enrolled 72 participants: 25% female; 38% Black; median age, 52 years; CD4 cell count &amp;lt;200 cells\/\u03bcL, 64% (&amp;lt;50 cells\/\u03bcL, 22%). At week 156, 61% (43\/70) had HIV RNA &amp;lt;50\u2005copies\/mL by FDA Snapshot Algorithm, 16% (11\/70) had \u226550\u2005copies\/mL, and 23% (16\/70) had missing data; by missing = excluded analysis, 85% (44\/52) had HIV RNA &amp;lt;50\u2005copies\/mL. Mean CD4 cell count increase from baseline to week 156 was 164 cells\/\u03bcL (95% CI: 116\u2013211). Through week 156, 14\/72 participants developed emergent LEN resistance. Injection site reactions were mostly Grade 1\/2, and frequency declined over time. Through week 156, two participants discontinued lenacapavir due to Grade 1 injection site nodules.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lenacapavir plus an optimized background antiretroviral regimen maintained a high rate of virologic suppression at week 156 with continued increases in CD4 counts. Lenacapavir was well tolerated with a favorable safety profile and very low rates of lenacapavir discontinuation. These data demonstrate longer-term efficacy and safety of lenacapavir for heavily treatment-experienced people with multidrug-resistant HIV.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofaf763","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T12:49:16Z","timestamp":1765889356000},"source":"Crossref","is-referenced-by-count":8,"title":["Subcutaneous Lenacapavir in People With Multidrug-Resistant HIV-1: 156 Week Results of the CAPELLA Study"],"prefix":"10.1093","volume":"13","author":[{"given":"Onyema","family":"Ogbuagu","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Yale School of Medicine , New Haven, Connecticut ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7487-1894","authenticated-orcid":false,"given":"Andrew","family":"Wiznia","sequence":"additional","affiliation":[{"name":"Jacobi Medical Center, Albert Einstein College of Medicine , Bronx, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1120-7085","authenticated-orcid":false,"given":"Joseph P","family":"McGowan","sequence":"additional","affiliation":[{"name":"Center for AIDS Research and Treatment, Northwell Health , Manhasset, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel S","family":"Berger","sequence":"additional","affiliation":[{"name":"Northstar Healthcare , Chicago, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine M","family":"Creticos","sequence":"additional","affiliation":[{"name":"Howard Brown Health , Chicago, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7478-7609","authenticated-orcid":false,"given":"Debbie","family":"Hagins","sequence":"additional","affiliation":[{"name":"Coastal District Care Clinic , Savannah, Georgia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theo","family":"Hodge","sequence":"additional","affiliation":[{"name":"Washington Health Institute , Washington, District of Columbia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olayemi","family":"Osiyemi","sequence":"additional","affiliation":[{"name":"Triple O Research Institute PA , West Palm Beach, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Sims","sequence":"additional","affiliation":[{"name":"St Hope Foundation , Houston, Texas ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Wheeler","sequence":"additional","affiliation":[{"name":"Infectious Diseases Physicians, Inc. , Annandale, Virginia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0911-4237","authenticated-orcid":false,"given":"Nicolas A","family":"Margot","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadas","family":"Dvory-Sobol","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5263-9613","authenticated-orcid":false,"given":"Martin S","family":"Rhee","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , Foster City, California 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