{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T23:59:28Z","timestamp":1790812768202,"version":"4.1.0"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T00:00:00Z","timestamp":1741824000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck & Co, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Doravirine\/islatravir is an investigational regimen that is being studied for human immunodeficiency virus type 1 (HIV-1) treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this phase 3, double-blind, double-dummy trial (ClinicalTrials.gov NCT04233879), previously untreated adults with HIV-1 were randomized (1:1) and stratified by HIV-1 RNA (\u2264\/&amp;gt;100 000 copies\/mL) and CD4 count (&amp;lt;\/\u2265200 cells\/\u00b5L) to doravirine\/islatravir (100\/0.75 mg) or bictegravir\/emtricitabine\/tenofovir alafenamide (50\/200\/25 mg) orally once-daily (primary endpoint: percentage of participants with HIV-1 RNA &amp;lt;50 copies\/mL at week 48; US Food and Drug Administration snapshot, 10% noninferiority margin).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 597 participants were treated; enrollment stopped early due to decreases in CD4 and lymphocyte counts observed in other islatravir studies. Doravirine\/islatravir was noninferior to bictegravir\/emtricitabine\/tenofovir alafenamide: 265 of 298 (88.9%) versus 264 of 299 (88.3%) had HIV-1 RNA &amp;lt;50 copies\/mL (difference, 0.5%; 95% confidence interval [CI]: \u22124.7, 5.6). Mean change from baseline in CD4 count was +182 and +234 cells\/\u00b5L (difference, \u221250; 95% CI: \u221279, \u221221) with doravirine\/islatravir versus bictegravir\/emtricitabine\/tenofovir alafenamide. Mean change in lymphocyte count was 0.01 and 0.21 \u00d7 109\/L (difference, \u22120.20; 95% CI: \u22120.30, \u22120.10). Adverse events (AEs) occurred in 90.6% and 87.3% of participants, with coronavirus disease 2019 being most common (14.1%, 16.4%). Treatment-related AEs were similar (28.9%, 25.8%). AEs that led to discontinuations were higher with doravirine\/islatravir (8.7%, 3.7%) due to protocol-specified criteria that required discontinuation for decreased CD4 and lymphocyte counts.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Doravirine\/islatravir (100\/0.75 mg) once-daily was noninferior to bictegravir\/emtricitabine\/tenofovir alafenamide through week 48 for initial HIV-1 treatment. Due to decreases in CD4 and lymphocyte counts, development of this dose of doravirine\/islatravir was stopped.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT04233879.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciaf077","type":"journal-article","created":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T10:43:56Z","timestamp":1741862636000},"page":"322-332","source":"Crossref","is-referenced-by-count":19,"title":["Doravirine\/Islatravir (100\/0.75 mg) Once-Daily Compared With Bictegravir\/Emtricitabine\/Tenofovir Alafenamide as Initial HIV-1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial"],"prefix":"10.1093","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2858-3888","authenticated-orcid":false,"given":"J\u00fcrgen K","family":"Rockstroh","sequence":"first","affiliation":[{"name":"Department of Medicine I, University Hospital Bonn , Bonn ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6553-691X","authenticated-orcid":false,"given":"Roger","family":"Paredes","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol , Badalona ,","place":["Spain"]},{"name":"IrsiCaixa AIDS Research Institute , Badalona ,","place":["Spain"]},{"name":"Center for Global Health and Diseases, Department of Pathology, Case Western Reserve University School of Medicine , Cleveland, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9381-1931","authenticated-orcid":false,"given":"Pedro","family":"Cahn","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n Hu\u00e9sped , Buenos Aires ,","place":["Argentina"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Michel","family":"Molina","sequence":"additional","affiliation":[{"name":"University of Paris Cit\u00e9 , INSERM UMR1342 Biology and Pathogenesis of Viral Infections, IRSL, Paris ,","place":["France"]},{"name":"Department of Infectious Diseases, Saint-Louis and Lariboisi\u00e8re Hospitals, AP-HP , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2707-1533","authenticated-orcid":false,"given":"Simiso M","family":"Sokhela","sequence":"additional","affiliation":[{"name":"Ezintsha, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3687-8168","authenticated-orcid":false,"given":"Federico","family":"Hinestrosa","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Orlando Immunology Center , Orlando, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0616-3623","authenticated-orcid":false,"given":"Sheetal","family":"Kassim","sequence":"additional","affiliation":[{"name":"Desmond Tutu Health Foundation , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Cunningham","sequence":"additional","affiliation":[{"name":"La Paz University Hospital , Madrid ,","place":["Spain"]},{"name":"Pueblo Family Physicians , Phoenix, Arizona ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2914-959X","authenticated-orcid":false,"given":"Jade","family":"Ghosn","sequence":"additional","affiliation":[{"name":"Assistance Publique-H\u00f4pitaux de Paris.Nord, H\u00f4pital Bichat-Claude Bernard, Service des Maladies Infectieuses et Tropicales , Paris ,","place":["France"]},{"name":"Universit\u00e9 Paris Cit\u00e9, INSERM UMR1137, IAME , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes R","family":"Bogner","sequence":"additional","affiliation":[{"name":"Department of Medicine IV, LMU University Hospital, LMU Munich , Munich ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9191-9984","authenticated-orcid":false,"given":"Hiroyuki","family":"Gatanaga","sequence":"additional","affiliation":[{"name":"AIDS Clinical Center, National Center Global Health and Medicine , Tokyo ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernest","family":"Asante-Appiah","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey 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