{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T14:55:58Z","timestamp":1768316158031,"version":"3.49.0"},"reference-count":51,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,1,9]],"date-time":"2013-01-09T00:00:00Z","timestamp":1357689600000},"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":[[2013,8]]},"abstract":"Objectives<\/jats:title>The aim of the study was to compare the neuropsychiatric safety and tolerability of rilpivirine (TMC<\/jats:styled-content>278) vs.<\/jats:italic> efavirenz in a preplanned pooled analysis of data from the ECHO and THRIVE studies which compared the safety and efficacy of the two drugs in HIV\u20101 infected treatment na\u00efve adults.<\/jats:p><\/jats:sec>Methods<\/jats:title>ECHO<\/jats:styled-content> and THRIVE<\/jats:styled-content> were randomized, double\u2010blind, double\u2010dummy, 96\u2010week, international, phase 3 trials comparing the efficacy, safety and tolerability of rilpivirine 25\u2009mg vs.<\/jats:italic> efavirenz 600\u2009mg once daily in combination with two background nucleoside\/tide reverse transcriptase inhibitors. Safety and tolerability analyses were conducted when all patients had received at least 48 weeks of treatment or discontinued earlier. Differences between treatments in the incidence of neurological and psychiatric adverse events (AEs<\/jats:styled-content>) of interest were assessed in preplanned statistical analyses using Fisher's exact test.<\/jats:p><\/jats:sec>Results<\/jats:title>At the time of the week 48 analysis, the cumulative incidences in the rilpivirine vs.<\/jats:italic> efavirenz groups of any grade 2\u20134 treatment\u2010related AEs<\/jats:styled-content> and of discontinuation because of AEs<\/jats:styled-content> were 16% vs.<\/jats:italic> 31% (P<\/jats:italic>\u2009<\u20090.0001) and 3% vs.<\/jats:italic> 8% (P<\/jats:italic>\u2009=\u20090.0005), respectively. The incidence of treatment\u2010related neuropsychiatric AEs<\/jats:styled-content> was 27% vs.<\/jats:italic> 48%, respectively (P<\/jats:italic>\u2009<\u20090.0001). The incidence of treatment\u2010related neurological AEs<\/jats:styled-content> of interest was 17% vs.<\/jats:italic> 38% (P<\/jats:italic>\u2009<\u20090.0001), and that of treatment\u2010related psychiatric AEs<\/jats:styled-content> of interest was 15% vs.<\/jats:italic> 23% (P<\/jats:italic>\u2009=\u20090.0002). Dizziness and abnormal dreams\/nightmares occurred significantly less frequently with rilpivirine vs.<\/jats:italic> efavirenz (P<\/jats:italic>\u2009<\u20090.01). In both groups, patients with prior neuropsychiatric history tended to report more neuropsychiatric AEs<\/jats:styled-content> but rates remained lower for rilpivirine than for efavirenz.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Rilpivirine was associated with fewer neurological and psychiatric AEs<\/jats:styled-content> of interest than efavirenz over 48 weeks in treatment\u2010na\u00efve, HIV<\/jats:styled-content>\u20101\u2010infected adults.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12012","type":"journal-article","created":{"date-parts":[[2013,1,9]],"date-time":"2013-01-09T13:35:35Z","timestamp":1357738535000},"page":"391-400","source":"Crossref","is-referenced-by-count":33,"title":["Neurological and psychiatric tolerability of rilpivirine (TMC<\/scp>278) vs.<\/i> efavirenz in treatment\u2010na\u00efve, HIV<\/scp>\u20101\u2010infected patients at 48 weeks"],"prefix":"10.1111","volume":"14","author":[{"given":"AM","family":"Mills","sequence":"first","affiliation":[{"name":"Anthony Mills MD Inc. 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