{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:32:43Z","timestamp":1777379563725,"version":"3.51.4"},"reference-count":37,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2019,12,31]],"date-time":"2019-12-31T00:00:00Z","timestamp":1577750400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,31]],"date-time":"2019-12-31T00:00:00Z","timestamp":1577750400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["AIDS Research and Human Retroviruses"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:p>\n                    Darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) 800\/150\/200\/10\u2009mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping\/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) \u2265400 copies\/mL at failure\/later time points.\n                    <jats:italic toggle=\"yes\">Post hoc<\/jats:italic>\n                    analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL &lt;50 copies\/mL) in EMERALD. Through week 48 across both studies, no darunavir, primary PI, or tenofovir resistance-associated mutations (RAMs) were observed in HIV-1 viruses of 1,125 participants receiving D\/C\/F\/TAF or 629 receiving boosted darunavir plus emtricitabine\/tenofovir-disoproxil-fumarate. In AMBER, the nucleos(t)ide analog reverse transcriptase inhibitor (N(t)RTI) RAM M184I\/V was identified in HIV-1 of one participant during D\/C\/F\/TAF treatment. M184V was detected pretreatment as a minority variant (9%). In EMERALD, in participants with prior VF and genoarchive data (\n                    <jats:italic toggle=\"yes\">N<\/jats:italic>\n                    \u2009=\u2009140; 98 D\/C\/F\/TAF and 42 control), 4% had viruses with darunavir RAMs, 38% with emtricitabine RAMs, mainly at position 184 (41% not fully susceptible to emtricitabine), 4% with tenofovir RAMs, and 21%\u2009\u2265\u20093 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL &lt;50 copies\/mL at week 48 or prior discontinuation. D\/C\/F\/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I\/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response.\n                  <\/jats:p>","DOI":"10.1089\/aid.2019.0111","type":"journal-article","created":{"date-parts":[[2019,9,13]],"date-time":"2019-09-13T07:48:07Z","timestamp":1568360887000},"page":"48-57","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir\/Cobicistat\/Emtricitabine\/Tenofovir Alafenamide (D\/C\/F\/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials"],"prefix":"10.1177","volume":"36","author":[{"given":"Erkki","family":"Lathouwers","sequence":"first","affiliation":[{"name":"Janssen Pharmaceutica NV, Beerse, Belgium."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric 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