{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T04:05:23Z","timestamp":1790827523541,"version":"4.1.0"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T00:00:00Z","timestamp":1749081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100020953","name":"Taiwan Centers for Disease Control","doi-asserted-by":"publisher","award":["MOHW112-CDC-C-114-000103"],"award-info":[{"award-number":["MOHW112-CDC-C-114-000103"]}],"id":[{"id":"10.13039\/100020953","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This open-label, randomized clinical trial determined plasma bictegravir trough concentration (Ctrough) and compared virological efficacy with daily bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF) versus BIC\/FTC\/TAF taken five-days-on-two-days-off (FOTO) in people with HIV (PWH).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Sixty PWH aged \u226520\u2005years with plasma HIV RNA load (PVL) of &amp;lt;50\u2005copies\/mL for \u22656\u2005months after having received daily BIC\/FTC\/TAF were randomized (1:1) to daily versus FOTO BIC\/FTC\/TAF. The primary endpoint was plasma bictegravir Ctrough above the in vitro protein-adjusted 95% effective concentration (162\u2005ng\/mL) at Weeks 4, 28 and 52. The secondary endpoints were PVL\u200a&amp;lt;\u200a50\u2005copies\/mL and weight and renal and metabolic parameters at the same time points. After Week 52, all participants entered the 48-week extension phase to receive FOTO BIC\/FTC\/TAF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>There were no significant differences in the baseline clinical characteristics, including drug-metabolizing gene polymorphisms, between the two groups. In the FOTO group, 90%, 93.3% and 100% of participants achieved a bictegravir Ctrough of &amp;gt;162\u2005ng\/mL at Weeks 4, 28 and 52, respectively. In intention-to-treat analysis, PVL of &amp;lt;50\u2005copies\/mL at Weeks 4, 28 and 52 was achieved by 100%, 93.3% and 100%, respectively, in the FOTO group, compared with 96.7%, 93.3% and 96.7% in the daily group. All five participants in the FOTO group with bictegravir Ctrough of &amp;lt;162\u2005ng\/mL at Weeks 4 and 28 maintained PVL &amp;lt;50\u2005copies\/mL. Of 57 (95.0%) participants who entered the extension phase, 56 (98.2%) completed the study and all maintained PVL &amp;lt;50\u2005copies\/mL at extension Week 48.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We showed PWH could successfully maintain sufficient bictegravir exposure and virological suppression with FOTO BIC\/FTC\/TAF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT06773754.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jac\/dkaf186","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T07:46:57Z","timestamp":1748418417000},"page":"2179-2186","source":"Crossref","is-referenced-by-count":6,"title":["Five-days-on-two-days-off (FOTO) versus daily bictegravir\/emtricitabine\/tenofovir alafenamide in virologically suppressed people with HIV: a pilot randomized clinical trial"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0074-7721","authenticated-orcid":false,"given":"Hsin-Yun","family":"Sun","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine , Taipei ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya-Ting","family":"Lin","sequence":"additional","affiliation":[{"name":"School of Pharmacy, National Taiwan University College of Medicine , Taipei ,","place":["Taiwan"]},{"name":"The Metabolomics Core Laboratory, Centers of Genomic and Precision Medicine, National Taiwan University , Taipei ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Chi","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Medical Research, The 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