{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T19:10:50Z","timestamp":1793473850188,"version":"4.5.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2020,7,15]],"date-time":"2020-07-15T00:00:00Z","timestamp":1594771200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","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":[[2021,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Bictegravir (B)\/emtricitabine (F)\/tenofovir alafenamide (TAF) is guideline-recommended treatment for human immunodeficiency virus type 1 (HIV-1). We evaluated whether people receiving dolutegravir (DTG) plus F\/TAF or F\/TDF (tenofovir disoproxil fumarate) with viral suppression can switch to B\/F\/TAF without compromising safety or efficacy, regardless of preexisting nucleoside reverse transcriptase inhibitor (NRTI) resistance.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this multicenter, randomized, double-blinded, active-controlled, noninferiority trial, we enrolled adults who were virologically suppressed for \u22656 months before screening (with documented\/suspected NRTI resistance) or \u22653 months before screening (with no documented\/suspected NRTI resistance) on DTG plus either F\/TDF or F\/TAF. We randomly assigned (1:1) participants to switch to B\/F\/TAF or DTG\u2009+\u2009F\/TAF once daily for 48 weeks, each with matching placebo. The primary endpoint was proportion of participants with plasma HIV-1 RNA \u226550 copies\/mL at week 48 (snapshot algorithm); the prespecified noninferiority margin was 4%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Five hundred sixty-seven adults were randomized; 565 were treated (284 B\/F\/TAF, 281 DTG\u2009+\u2009F\/TAF). At week 48, B\/F\/TAF was noninferior to DTG\u2009+\u2009F\/TAF, as 0.4% (1\/284) vs 1.1% (3\/281) had HIV-1 RNA \u226550 copies\/mL (difference, \u22120.7% [95.001% confidence interval {CI}, \u22122.8% to 1.0%]). There were no significant differences in efficacy among participants with suspected or confirmed prior NRTI resistance (n = 138). No participant had treatment-emergent drug resistance. Median weight change from baseline at week 48 was +1.3 kg (B\/F\/TAF) vs +1.1 kg (DTG\u2009+\u2009F\/TAF) (P = .46). Weight change differed by baseline NRTIs (+2.2 kg [F\/TDF] and +0.6 kg [F\/TAF], P &amp;lt; .001), with no differences between B\/F\/TAF and DTG\u2009+\u2009F\/TAF.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The single-tablet regimen B\/F\/TAF is a safe, effective option for people virologically suppressed on DTG plus either F\/TDF or F\/TAF, including in individuals with preexisting resistance to NRTIs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT03110380.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciaa988","type":"journal-article","created":{"date-parts":[[2020,7,10]],"date-time":"2020-07-10T19:11:07Z","timestamp":1594408267000},"page":"e485-e493","source":"Crossref","is-referenced-by-count":116,"title":["Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus"],"prefix":"10.1093","volume":"73","author":[{"given":"Paul E","family":"Sax","sequence":"first","affiliation":[{"name":"Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen K","family":"Rockstroh","sequence":"additional","affiliation":[{"name":"University Hospital Bonn, Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne F","family":"Luetkemeyer","sequence":"additional","affiliation":[{"name":"University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yazdan","family":"Yazdanpanah","sequence":"additional","affiliation":[{"name":"H\u00f4pital Bichat Claude Bernard, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Ward","sequence":"additional","affiliation":[{"name":"Dupont Circle Physicians, Washington, District of Columbia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benoit","family":"Trottier","sequence":"additional","affiliation":[{"name":"Clinique de Medecine Urbaine du Quartier Latin, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armin","family":"Rieger","sequence":"additional","affiliation":[{"name":"University of Vienna Medical School, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Liu","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rima","family":"Acosta","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean E","family":"Collins","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana M","family":"Brainard","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hal","family":"Martin","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"GS-US-380\u20134030 Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,7,15]]},"reference":[{"key":"2021071520095745700_CIT0001","author":"European AIDS Clinical Society"},{"key":"2021071520095745700_CIT0002","author":"Panel on Antiretroviral Guidelines for 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