{"id":1634,"date":"2009-06-03T09:07:16","date_gmt":"2009-06-03T09:07:16","guid":{"rendered":"http:\/\/localhost.localdomain\/wpmu\/htb\/?p=1634"},"modified":"2013-08-16T13:47:26","modified_gmt":"2013-08-16T13:47:26","slug":"etravirine-dose-selection-in-children-aged-6-to-17","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/1634","title":{"rendered":"Etravirine dose selection in children aged 6 to 17"},"content":{"rendered":"<p><strong>Polly Clayden, HIV i-Base<\/strong><\/p>\n<p><strong>Chistoph Konigs and coworkers from paediatric centres in Europe performed a dose finding study of etravirine (ETR) in treatment experienced children &gt;6 years and weighing &gt;20kg.<\/strong><\/p>\n<p>This was a phase 1, open label trial in two sequential stages. 21 HIV-positive children on stable lopinavir\/r-based ART with viral load &lt;50 copies\/mL were enrolled in each stage. Children in stage I received 4mg\/kg ETR bid following a meal (included in HTB reports from CROI last year). Children in Stage II received 5.2mg\/kg ETR bid following a meal. ETR was added to background regimen for 7 days. After the morning dose on day 8 the investigators performed a 12 hour PK evaluation. 100mg and proportional 25mg tablets were used in this study. PK for 19 and 20 children were available in stages I and II, respectively.<\/p>\n<p>The investigators reported the mean (SD) Cmax in stage I and II, respectively, was 495 (453) and 757 (680) ng\/mL; Cmin was 184 (151) and 294 (278) ng\/mL; and AUC12h was 4050 (3602) and 6141 (5586) ng\u0095h\/mL.<\/p>\n<p>When they compared PK parameters to those reported in adult trials (n = 575), population derived Cmin was 393 [391] ng\/mL and AUC12h was 5506 [4710] ng\u0095h\/mL, they found the levels achieved in children participating in stage II with the higher dose to be more appropriate.<\/p>\n<p>All children had a viral load &lt;50 copies\/mL on day 8. The majority of side effects were grade 1 or 2, most commonly rhinitis or headache. Two children in stage 1 had a mild to moderate rash on day 8. No child discontinued treatment due to toxicity.<\/p>\n<p>The target dose of ETR in children 6-17 years was selected as 5.2mg\/kg bid, which provides comparable exposure to the adult dose of 200mg bid.<\/p>\n<p>Further studies in children are ongoing or planned.<\/p>\n<h3>Comment<\/h3>\n<p><strong>Tibotec intend to market the 25-mg tablet for children (and adults who have difficulty swallowing the 100-mg tablets) once they have the initial paediatric indication.<\/strong><\/p>\n<p>Reference:<\/p>\n<p>Konigs et al. Pharmacokinetics and dose selection of etravirine in HIV-infected children between 6 and 17 years inclusive. 16th CROI, February 2009, Montreal, Canada. Poster abstract 879.<br \/>\n<a href=\"http:\/\/www.retroconference.org\/2009\/Abstracts\/35446.htm\">http:\/\/www.retroconference.org\/2009\/Abstracts\/35446.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base Chistoph Konigs and coworkers from paediatric centres in Europe performed a dose finding study of etravirine (ETR) in treatment experienced children &gt;6 years and weighing &gt;20kg. This was a phase 1, open label trial in two &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32],"tags":[63],"class_list":["post-1634","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-croi-2009"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1634","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=1634"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1634\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=1634"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=1634"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=1634"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}