{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:13:35Z","timestamp":1747185215486,"version":"3.40.5"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,8,15]],"date-time":"2022-08-15T00:00:00Z","timestamp":1660521600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017183","name":"Janssen Scientific Affairs","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017183","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Our objective was to evaluate the prevalence of pre\u2010existing neurological and\/or psychiatric comorbidities (NPCs) and efficacy\/safety outcomes for participants with versus without baseline NPCs in AMBER and EMERALD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>AMBER (treatment\u2010na\u00efve population) and EMERALD (virologically suppressed population) were phase III randomized studies of darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) 800\/150\/200\/10\u00a0mg. The primary objective of this post hoc analysis was to assess virological response (HIV\u20101 RNA &lt;50 copies\/mL) at week 48 by intent\u2010to\u2010treat US Food and Drug Administration snapshot analysis comparing participants with and without baseline NPCs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among participants in AMBER, 88\/362 (24%) in the D\/C\/F\/TAF arm and 99\/363 (27%) in the control arm had baseline NPCs; in EMERALD, 294\/763 (39%; D\/C\/F\/TAF) and 166\/378 (44%; control) participants had baseline NPCs. At baseline, psychiatric NPCs were more common than neurological NPCs in both studies; the most common of each type were depression and headache, respectively. High virological response rates were achieved with D\/C\/F\/TAF across studies regardless of baseline NPCs at weeks 48 (range 86%\u201395%) and 96 (range 80%\u201391%). No participants in either study with a baseline NPC prematurely discontinued because of a study drug\u2013related neurological or psychiatric adverse event.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>D\/C\/F\/TAF may be a suitable treatment option for individuals with HIV\u20101 and NPCs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13377","type":"journal-article","created":{"date-parts":[[2022,8,16]],"date-time":"2022-08-16T05:06:37Z","timestamp":1660626397000},"page":"279-289","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide in treatment\u2010na\u00efve (<scp>AMBER<\/scp>) and virologically suppressed (<scp>EMERALD<\/scp>) participants with neurological and\/or psychiatric comorbidities: Week 96 subgroup analysis"],"prefix":"10.1111","volume":"24","author":[{"given":"Keith","family":"Dunn","sequence":"first","affiliation":[{"name":"Janssen Scientific Affairs, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Bushen","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donghan","family":"Luo","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiyun","family":"Cai","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard Bruce","family":"Simonson","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6584-1666","authenticated-orcid":false,"given":"David","family":"Anderson","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,15]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001269"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2013.301633"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijnurstu.2014.01.015"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0092842"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.58.8.721"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12981-018-0188-9"},{"key":"e_1_2_8_8_1","first-page":"WC01\u2010WC04","article-title":"Prevalence of depression in people living with HIV\/AIDS undergoing ART and factors associated with it","volume":"8","author":"Bhatia MS","year":"2014","journal-title":"J Clin Diagn Res"},{"key":"e_1_2_8_9_1","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Available at:https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/adult\u2010adolescent\u2010arv\/guidelines\u2010adult\u2010adolescent\u2010arv.pdf. Accessed May 23 2022."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001817"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002463"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(17)30179-0"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2019.104543"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/PSY.0b013e31816aa0cc"},{"key":"e_1_2_8_15_1","unstructured":"World Health Organization.Depression and Other Common Mental Disorders: Global Health Estimates. 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Foster City CA: Gilead Sciences; June 2019."},{"volume-title":"(dolutegravir and lamivudine) [package insert]","year":"2020","author":"DOVATO","key":"e_1_2_8_18_1"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkx053"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215541"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(19)30080-3"}],"container-title":["HIV Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13377","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hiv.13377","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13377","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T00:20:08Z","timestamp":1692663608000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hiv.13377"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,15]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,3]]}},"alternative-id":["10.1111\/hiv.13377"],"URL":"https:\/\/doi.org\/10.1111\/hiv.13377","archive":["Portico"],"relation":{},"ISSN":["1464-2662","1468-1293"],"issn-type":[{"type":"print","value":"1464-2662"},{"type":"electronic","value":"1468-1293"}],"subject":[],"published":{"date-parts":[[2022,8,15]]},"assertion":[{"value":"2022-03-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-15","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}