{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T18:22:59Z","timestamp":1746728579329,"version":"3.37.3"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,2,15]],"date-time":"2021-02-15T00:00:00Z","timestamp":1613347200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In AMBER and EMERALD, darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) 800\/150\/200\/10\u2009mg demonstrated high virological response and low virological failure (VF) through week 96. Week 96 resistance analyses are presented. Post\u2010baseline samples for genotyping\/phenotyping were analyzed from protocol\u2010defined\u2010VFs with viral load (VL)\u2009\u2265\u2009400\u2009copies\/ml at failure\/later time points. Post\u2010hoc analyses were deep sequencing (AMBER) and HIV\u20101 proviral DNA sequencing from baseline samples (VL\u2009&lt;\u200950\u2009copies\/ml) (EMERALD). Through week 96 across studies, no darunavir, primary protease inhibitor (PI), or tenofovir resistance\u2010associated\u2010mutations (RAMs) occurred in patients continuing (<jats:italic>N<\/jats:italic>\u2009=\u20091125) or switching to D\/C\/F\/TAF (<jats:italic>N<\/jats:italic>\u2009=\u2009715). M184I\/V (emtricitabine RAM) was detected in one patient in each arm of AMBER. In EMERALD D\/C\/F\/TAF patients with prior VF and baseline genoarchive data (<jats:italic>N<\/jats:italic>\u2009=\u200998), 4% had darunavir RAMs,\u00a036% emtricitabine RAMs, mainly at position 184 (32%), 4% tenofovir RAMs, and 19% \u22653 thymidine\u2010analogue\u2010associated\u2010mutations at screening. The predicted phenotype showed 0% had reduced susceptibility to darunavir, 37% to emtricitabine, and 22% to tenofovir. All achieved VL\u2009&lt;\u200950\u2009copies\/ml at week 96\/prior discontinuation, with no VF. D\/C\/F\/TAF has a high barrier to resistance; no darunavir, primary PI, or tenofovir RAMs occurred through 96 weeks in AMBER and EMERALD. In EMERALD, baseline archived darunavir, emtricitabine, and tenofovir RAMs in patients with prior VF did not preclude virologic response.<\/jats:p>","DOI":"10.1002\/jmv.26721","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T23:03:14Z","timestamp":1607641394000},"page":"3985-3990","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Week 96 resistance analyses of the once\u2010daily, single\u2010tablet regimen (STR) darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) in adults living with HIV\u20101 from the phase 3 randomized AMBER and EMERALD trials"],"prefix":"10.1002","volume":"93","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7516-2213","authenticated-orcid":false,"given":"Erkki","family":"Lathouwers","sequence":"first","affiliation":[{"name":"Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shirley","family":"Weinsteiger","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan","family":"Baugh","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development LLC Raritan New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Ghys","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Jezorwski","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Pennington New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"El Ghazi","family":"Mohsine","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika","family":"Van Landuyt","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"De Meyer","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,2,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2012.01060.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/1742-6405-11-39"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e328345ee95"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/15284336.2017.1387690"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001817"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(17)30179-0"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002463"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2019.104543"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2019.0111"},{"key":"e_1_2_9_11_1","unstructured":"EACS. 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Accessed February 9 2021."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.17025"},{"key":"e_1_2_9_14_1","first-page":"642","article-title":"2014 Update of the drug resistance mutations in HIV\u20101","volume":"22","author":"Wensing A","year":"2014","journal-title":"Top Antivir Med"},{"key":"e_1_2_9_15_1","first-page":"132","article-title":"2015 Update of the drug resistance mutations in HIV\u20101","volume":"23","author":"Wensing A","year":"2015","journal-title":"Top Antivir Med"},{"key":"e_1_2_9_16_1","first-page":"132","article-title":"2017 Update of the Drug Resistance Mutations in HIV\u20101","volume":"24","author":"Wensing A","year":"2016","journal-title":"Top Antivir Med"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz1213"},{"key":"e_1_2_9_18_1","unstructured":"Prescribing information for SYMTUZA\u00ae (darunavir cobicistat emtricitabine and tenofovir alafenamide) tablets. Janssen Pharmaceutical Companies 2018.https:\/\/www.janssenlabels.com\/package-insert\/product-monograph\/prescribing-information\/SYMTUZA-pi.pdf. Accessed February 9 2021."},{"key":"e_1_2_9_19_1","unstructured":"Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/PediatricGuidelines.pdf. 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