{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T06:42:28Z","timestamp":1772779348189,"version":"3.50.1"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T00:00:00Z","timestamp":1696896000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100017973","name":"International Maternal Pediatric Adolescent AIDS Clinical Trials Network","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017973","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["HHSN275201800001I"],"award-info":[{"award-number":["HHSN275201800001I"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI068632"],"award-info":[{"award-number":["UM1AI068632"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI068616"],"award-info":[{"award-number":["UM1AI068616"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI106716"],"award-info":[{"award-number":["UM1AI106716"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009947","name":"Merck Sharp & Dohme LLC","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>IMPAACT 2014 study is a phase I\/II, multicenter, open-label, nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed-dose combination (DOR FDC) in adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR FDC through 96 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants were adolescents aged 12 to &amp;lt;18 years who weighed at least 45 kg and who were either antiretroviral (ARV)-na\u00efve or virologically suppressed without documented resistance mutations to DOR\/3TC\/TDF. The efficacy endpoint was the proportion of participants with HIV-1 RNA &amp;lt;40 copies\/mL assessed at weeks 48 and 96 using the observed failure approach. Safety and tolerability outcomes were incidence of adverse events (AEs) and treatment discontinuations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 45 adolescents, median age 15 (range, 12\u201317) years, 58% females, were enrolled and 2 (4.4%) participants were ARV na\u00efve. Of the 45 participants, 42 (93.3%) completed the study and 41 (91.1%) completed the study treatment. At week 48, 41\/42 (97.6%; 95% confidence interval [CI], 87.4\u201399.9) and week 96, 37\/40 (92.5%; 95% CI, 79.6\u201398.4) participants had achieved or maintained HIV-1 RNA &amp;lt;40 copies\/mL. There were no treatment-related discontinuations due to AEs and no drug-related AEs \u2265grade 3 or deaths.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>We found once-daily dosing of DOR FDC to be safe and well tolerated for maintaining viral suppression through 96 weeks in adolescents living with HIV-1.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jpids\/piad078","type":"journal-article","created":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T10:44:15Z","timestamp":1696934655000},"page":"602-609","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy, Safety, and Tolerability of Doravirine\/Lamivudine\/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results Through Week 96 from IMPAACT 2014"],"prefix":"10.1093","volume":"12","author":[{"given":"Supattra","family":"Rungmaitree","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok ,","place":["Thailand"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0246-8187","authenticated-orcid":false,"given":"Linda","family":"Aurpibul","sequence":"additional","affiliation":[{"name":"Research Institute for Health Sciences, Chiang Mai University , Chiang Mai ,","place":["Thailand"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brookie M","family":"Best","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences and Pediatrics Department, School of Medicine-Rady Children\u2019s Hospital San Diego, University of California San Diego , San Diego, California ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiang","family":"Li","sequence":"additional","affiliation":[{"name":"Frontier Science Technology and Research Foundation , Madison, Wisconsin ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meredith G","family":"Warshaw","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. 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