{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T14:56:20Z","timestamp":1761663380232,"version":"3.37.3"},"reference-count":40,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T00:00:00Z","timestamp":1436832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2016,2]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> treatment guidelines endorse switching or simplification of antiretroviral therapy in therapy\u2010experienced patients with suppressed viraemia; ritonavir discontinuation may also enhance tolerability and reduce long\u2010term adverse events (<jats:styled-content style=\"fixed-case\">AEs<\/jats:styled-content>). This open\u2010label, multicentre, noninferiority study enrolled <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101\u2010infected, treatment\u2010experienced adults with confirmed <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content>\u2009\u2264\u200975 <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content> copies\/mL currently receiving tenofovir\/emtricitabine\u2009+\u2009atazanavir\/ritonavir (<jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">FTC<\/jats:styled-content>\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\/r) for \u2265\u20096 months with no reported history of virological failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants were randomized 1:2 to continue current treatment or switch to abacavir\/lamivudine + atazanavir (<jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>). Endpoints included the proportion of participants with <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content>\u2009&lt;\u200950 copies\/mL by time to loss of virological response (<jats:styled-content style=\"fixed-case\">TLOVR<\/jats:styled-content>), <jats:styled-content style=\"fixed-case\">AEs<\/jats:styled-content>, fasting lipids, and inflammatory, coagulation, bone and renal biomarkers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After 48 weeks, 76% (152 of 199) of <jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\u2010treated and 79% (77 of 97) of <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">FTC<\/jats:styled-content>\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\/r\u2010treated participants had <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content>\u2009&lt;\u200950 copies\/mL (<jats:styled-content style=\"fixed-case\">TLOVR<\/jats:styled-content>; <jats:italic>P<\/jats:italic>\u2009=\u20090.564). Other efficacy analyses yielded similar results. Rates of new grade 2\u20134 <jats:styled-content style=\"fixed-case\">AEs<\/jats:styled-content> were 45% in both groups, but an excess of hyperbilirubinaemia made the rate of treatment\u2010emergent grade 3\u20134 laboratory abnormalities higher with <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">FTC<\/jats:styled-content>\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\/r (36%) compared with <jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content> (19%). Most fasting lipid levels remained stable over time; high\u2010density lipoprotein (<jats:styled-content style=\"fixed-case\">HDL<\/jats:styled-content>) cholesterol increased modestly in <jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\u2010treated participants. Bone and renal biomarkers improved significantly between baseline and week 48 in participants taking <jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content> and were stable in participants taking <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">FTC<\/jats:styled-content>\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\/r. No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The <jats:styled-content style=\"fixed-case\">ABC<\/jats:styled-content>\/3TC\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content> treatment\u2010switch group had similar viral suppression rates up to 48 weeks to the <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">FTC<\/jats:styled-content>\u2009+\u2009<jats:styled-content style=\"fixed-case\">ATV<\/jats:styled-content>\/r comparator group, with lower rates of moderate\u2010 to high\u2010grade hyperbilirubinaemia and improvements in bone and renal biomarkers.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12281","type":"journal-article","created":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T21:57:35Z","timestamp":1436911055000},"page":"106-117","source":"Crossref","is-referenced-by-count":18,"title":["The <scp>ASSURE<\/scp> study: <scp>HIV<\/scp>\u20101 suppression is maintained with bone and renal biomarker improvement 48 weeks after ritonavir discontinuation and randomized switch to abacavir\/lamivudine\u2009+\u2009atazanavir"],"prefix":"10.1111","volume":"17","author":[{"given":"DA","family":"Wohl","sequence":"first","affiliation":[{"name":"AIDS Clinical Trials Unit University of North Carolina  Chapel Hill NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Bhatti","sequence":"additional","affiliation":[{"name":"AIDS Healthcare Foundation Beverly Hills  CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"CB","family":"Small","sequence":"additional","affiliation":[{"name":"New York Medical College  Valhalla NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H","family":"Edelstein","sequence":"additional","affiliation":[{"name":"Alameda County Medical Center  Oakland CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"HH","family":"Zhao","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Research Triangle Park  Research Triangle Park NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"DA","family":"Margolis","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Research Triangle Park  Research Triangle Park NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E","family":"DeJesus","sequence":"additional","affiliation":[{"name":"Orlando Immunology Center  Orlando FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"WG","family":"Weinberg","sequence":"additional","affiliation":[{"name":"Kaiser Foundation Health Plan of Georgia, Inc.  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