{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,12]],"date-time":"2025-08-12T22:09:28Z","timestamp":1755036568188,"version":"3.37.3"},"reference-count":43,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2014,3,3]],"date-time":"2014-03-03T00:00:00Z","timestamp":1393804800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2014,10]]},"abstract":"Objectives<\/jats:title>PIANO<\/jats:styled-content> (P<\/jats:styled-content>aediatric study of I<\/jats:styled-content>ntelence A<\/jats:styled-content>s an NNRTI O<\/jats:styled-content>ption; TMC125\u2010C213<\/jats:styled-content>; NCT00665847<\/jats:styled-content>) assessed the safety\/tolerability, antiviral activity and pharmacokinetics of etravirine plus an optimized background regimen (OBR<\/jats:styled-content>) in treatment\u2010experienced, HIV<\/jats:styled-content>\u20101\u2010infected children (\u2265\u20096 to <\u200912 years) and adolescents (\u2265\u200912 to <\u200918 years) over 48 weeks.<\/jats:p><\/jats:sec>Methods<\/jats:title>In a phase II<\/jats:styled-content>, open\u2010label, single\u2010arm study, 101 treatment\u2010experienced patients (41 children; 60 adolescents) with screening viral load (VL<\/jats:styled-content>) \u2265\u2009500 HIV<\/jats:styled-content>\u20101 RNA<\/jats:styled-content> copies\/mL received etravirine 5.2\u2009mg\/kg (maximum dose 200\u2009mg) twice a day (bid) plus OBR<\/jats:styled-content>.<\/jats:p><\/jats:sec>Results<\/jats:title>Sixty\u2010seven per cent of patients had previously used efavirenz or nevirapine. At week 48, the most common treatment\u2010related grade \u2265\u20092 adverse event (AE<\/jats:styled-content>) was rash (13%); 12% experienced grade 3 AEs<\/jats:styled-content>. Only two grade 4 AEs<\/jats:styled-content> occurred (both thrombocytopaenia, not etravirine related). At week 48, 56% of patients (68% children; 48% adolescents) achieved a virological response (VL<\/jats:styled-content><50\u2009copies\/mL; intent\u2010to\u2010treat, noncompleter=failure). Factors predictive of response were adherence >\u200995%, male sex, low baseline etravirine weighted genotypic score and high etravirine trough concentration (C<\/jats:styled-content><\/jats:italic>0h<\/jats:sub>). Seventy\u2010six patients (75%) completed the trial; most discontinuations occurred because of protocol noncompliance or AEs<\/jats:styled-content> (8% each). Sixty\u2010five per cent of patients were >\u200995% adherent by questionnaire and 39% by pill count. Forty\u2010one patients experienced virological failure (VF<\/jats:styled-content>; time\u2010to\u2010loss\u2010of\u2010virological\u2010response non\u2010VF<\/jats:styled-content>\u2010censored algorithm) (29 nonresponders; 12 rebounders). Of 30 patients with VF<\/jats:styled-content> with paired baseline\/endpoint genotypes, 18 (60%) developed nonnucleoside reverse transcriptase inhibitor (NNRTI<\/jats:styled-content>) mutations, most commonly Y181C<\/jats:styled-content>. Mean etravirine area under the plasma concentration\u2013time curve over 12\u2009h (AUC0\u201312h<\/jats:sub><\/jats:styled-content>; 5216\u2009ng h\/mL) and C<\/jats:styled-content><\/jats:italic>0h<\/jats:sub> (346\u2009ng\/mL) were comparable to adult target values.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Results with etravirine 5.2\u2009mg\/kg bid (with OBR<\/jats:styled-content>) in this treatment\u2010experienced paediatric population and etravirine 200\u2009mg bid in treatment\u2010experienced adults were comparable. Etravirine is an NNRTI<\/jats:styled-content> option for treatment\u2010experienced paediatric patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12141","type":"journal-article","created":{"date-parts":[[2014,3,4]],"date-time":"2014-03-04T01:58:47Z","timestamp":1393898327000},"page":"513-524","source":"Crossref","is-referenced-by-count":16,"title":["Etravirine in treatment\u2010experienced, HIV<\/scp>\u20101\u2010infected children and adolescents: 48\u2010week safety, efficacy and resistance analysis of the phase II PIANO<\/scp> study"],"prefix":"10.1111","volume":"15","author":[{"given":"G","family":"Tudor\u2010Williams","sequence":"first","affiliation":[{"name":"Imperial College London UK"}]},{"given":"P","family":"Cahn","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n Hu\u00e9sped Buenos Aires Argentina"}]},{"given":"K","family":"Chokephaibulkit","sequence":"additional","affiliation":[{"name":"Mahidol University Bangkok Thailand"}]},{"given":"J","family":"Fourie","sequence":"additional","affiliation":[{"name":"Dr Jan Fourie Medical Practice Dundee KwaZulu\u2010Natal South Africa"}]},{"given":"C","family":"Karatzios","sequence":"additional","affiliation":[{"name":"McGill University Health Centre Montr\u00e9al Canada"}]},{"given":"S","family":"Dincq","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA Beerse Belgium"}]},{"given":"M","family":"Opsomer","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA Beerse Belgium"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6857-2572","authenticated-orcid":false,"given":"TN","family":"Kakuda","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC Titusville NJ USA"}]},{"given":"S","family":"Nijs","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA Beerse Belgium"}]},{"given":"L","family":"Tambuyzer","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA Beerse Belgium"}]},{"given":"FL","family":"Tomaka","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC Titusville NJ USA"}]},{"name":"PIANO study group","sequence":"additional","affiliation":[]}],"member":"311","published-online":{"date-parts":[[2014,3,3]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/11587300-000000000-00000"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.332.7551.1183"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2009.00759.x"},{"key":"e_1_2_7_5_1","unstructured":"Department of Health and Human Services.Guidelines for the use of antiretroviral agents in pediatric HIV infection(February2014). 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