{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T02:41:01Z","timestamp":1791168061322,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2012,10,23]],"date-time":"2012-10-23T00:00:00Z","timestamp":1350950400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>This paper presents the final analysis of once\u2010daily darunavir\/ritonavir (<jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r) <jats:italic>vs<\/jats:italic>. lopinavir\/ritonavir (<jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r) in treatment\u2010na\u00efve <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101\u2010infected adults.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">ARTEMIS<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">AntiRetroviral T<\/jats:styled-content>herapy with <jats:styled-content style=\"fixed-case\">TMC<\/jats:styled-content>114 <jats:styled-content style=\"fixed-case\">ExaMined I<\/jats:styled-content>n na\u00efve <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>ubjects; <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00258557) was a randomized, open\u2010label, phase\u2010<jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>, 192\u2010week trial. Patients were stratified by baseline <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101 <jats:styled-content style=\"fixed-case\">RNA<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>4 count, and randomized to once\u2010daily <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r 800\/100\u2009mg or <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r 800\/200\u2009mg total daily dose (either once or twice daily) plus tenofovir\/emtricitabine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 689 randomized patients receiving treatment (<jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r: 343; <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r: 346), 85 and 114 patients in the <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r and <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r arms, respectively, had discontinued by week 192. Noninferiority was shown in the primary endpoint of virological response (<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\/<jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>) [<jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r: 68.8%; <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r: 57.2%; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001; intent to treat (<jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content>)\/time to loss of virological response; estimated difference in response 11.6% (95% confidence interval 4.4\u201318.8%)]. Statistical superiority in virological response of <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r over <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r was demonstrated for the primary endpoint (<jats:italic>P<\/jats:italic>\u2009=\u20090.002) and for the <jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content> non\u2010virological\u2010failure\u2010censored analysis (87.4% <jats:italic>vs<\/jats:italic>. 80.8%, respectively; <jats:italic>P<\/jats:italic>\u2009=\u20090.040). No protease inhibitor (<jats:styled-content style=\"fixed-case\">PI<\/jats:styled-content>) primary mutations developed and only low levels of nucleoside reverse transcriptase inhibitor (<jats:styled-content style=\"fixed-case\">NRTI<\/jats:styled-content>) resistance developed in virological failures in both groups. Significantly fewer discontinuations because of adverse events were observed with <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r (4.7%) than with <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r (12.7%; <jats:italic>P<\/jats:italic>\u2009=\u20090.005). Grade 2\u20134 treatment\u2010related diarrhoea was significantly less frequent with <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r than with <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r (5.0% <jats:italic>vs<\/jats:italic>. 11.3%, respectively; <jats:italic>P<\/jats:italic>\u2009=\u20090.003). <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r was associated with smaller median increases in total cholesterol and triglyceride levels than <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r. Changes in low\u2010 and high\u2010density lipoprotein cholesterol were similar between groups. Similar increases in aspartate aminotransferase and alanine aminotransferase for <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r and <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Over 192 weeks, once\u2010daily <jats:styled-content style=\"fixed-case\">DRV<\/jats:styled-content>\/r was noninferior and statistically superior in virological response to <jats:styled-content style=\"fixed-case\">LPV<\/jats:styled-content>\/r, with a more favourable gastrointestinal profile, demonstrating its suitability for long\u2010term use in treatment\u2010na\u00efve patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1468-1293.2012.01060.x","type":"journal-article","created":{"date-parts":[[2012,10,23]],"date-time":"2012-10-23T06:26:13Z","timestamp":1350973573000},"page":"49-59","source":"Crossref","is-referenced-by-count":144,"title":["Final 192\u2010week efficacy and safety of once\u2010daily darunavir\/ritonavir compared with lopinavir\/ritonavir in <scp>HIV<\/scp>\u20101\u2010infected treatment\u2010na\u00efve patients in the <scp>ARTEMIS<\/scp> trial"],"prefix":"10.1111","volume":"14","author":[{"given":"C","family":"Orkin","sequence":"first","affiliation":[{"name":"Barts and The London NHS Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"DeJesus","sequence":"additional","affiliation":[{"name":"Orlando Immunology Center  Orlando FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H","family":"Khanlou","sequence":"additional","affiliation":[{"name":"AIDS Healthcare Foundation  Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Stoehr","sequence":"additional","affiliation":[{"name":"Institute for Interdisciplinary Medicine  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Supparatpinyo","sequence":"additional","affiliation":[{"name":"Chiang Mai University  Chiang Mai Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Lathouwers","sequence":"additional","affiliation":[{"name":"Tibotec BVBA  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Lefebvre","sequence":"additional","affiliation":[{"name":"Janssen  Tilburg the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Opsomer","sequence":"additional","affiliation":[{"name":"Tibotec BVBA  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Van de Casteele","sequence":"additional","affiliation":[{"name":"Tibotec BVBA  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F","family":"Tomaka","sequence":"additional","affiliation":[{"name":"Tibotec Inc.  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