{"id":34377,"date":"2018-06-29T08:36:09","date_gmt":"2018-06-29T08:36:09","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=34377"},"modified":"2018-06-29T09:38:16","modified_gmt":"2018-06-29T09:38:16","slug":"etravirine-dispersible-paediatric-tablet-has-greater-bioavailability-when-dispersed-in-water-compared-to-swallowed-whole","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/34377","title":{"rendered":"Etravirine dispersible paediatric tablet has greater bioavailability when dispersed in water compared to swallowed whole \u00a0"},"content":{"rendered":"<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\">Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">Etravirine (ETR) oral clearance in young children who swallowed the dispersible paediatric formulation was half that achieved with the tablet dispersed in water, according to results from IMPAACT P1090. <\/span><\/b><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This finding in HIV positive children ages 1\u20136 years was presented at the 19th International Workshop on Clinical Pharmacology<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The population pharmacokinetics (PK) of ETR have previously been described in adults, adolescents, and children 6 years and above but not in younger populations. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This study aimed to characterise the population PK and pharmacokinetic\/pharmacodynamic (PK\/PD) relationships of ETR in HIV positive children ages 1 to &lt;6 years. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">IMPAACT P1090 is a phase 1\/2, multicentre, open-label study designed to evaluate the PK, optimal dose, safety, and tolerability of ETR in treatment-experienced children ages 1 to &lt;6 years. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Participants received ETR with at least two other active antiretrovirals, one of which was a ritonavir-boosted protease inhibitor (PI\/r). The study evaluated weight-based and weight-band based ETR doses. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">A 12-hour intensive PK was performed two weeks after starting ETR and sparse samples were collected through week 48. Twenty-five children were included.<\/span><\/p>\n<p class=\"HTBBODYtext\">Children receiving ETR showed considerable inter-individual variability \u2013 similar to adults. Apparent oral clearance was 50% lower in children who swallowed the tablet whole versus dispersed in water. Weight and age were not significant predictors in the model. Although country and use of PI\/r approached significance over-parameterisation of the model precluded their inclusion in the final model.<\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">PK parameters were not associated with viral load at week 24. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The investigators suggested that this model can aid in comparisons of ETR PK parameters and dose selection in this younger population versus those previously reported for adults, adolescents, and children over 6 years. <\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Reference<\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Ibrahim M et al. Population pharmacokinetics\/pharmacodynamics of etravirine in HIV-positive children ages 1-&lt;6 years. 19th International Workshop on Clinical Pharmacology. Baltimore. 22\u201324 May 2018. Oral abstract 20.<br \/>\n<\/span><a href=\"http:\/\/regist2.virology-education.com\/presentations\/2018\/Antiviralpk\/34_Ibrahim.pdf%20\" rel=\"noopener\">http:\/\/regist2.virology-education.com\/presentations\/2018\/Antiviralpk\/34_Ibrahim.pdf <\/a>(PDF)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base Etravirine (ETR) oral clearance in young children who swallowed the dispersible paediatric formulation was half that achieved with the tablet dispersed in water, according to results from IMPAACT P1090. This finding in HIV positive children ages &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32,34],"tags":[254],"class_list":["post-34377","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","category-pk-and-drug-interactions","tag-pk-workshop-2018"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34377","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=34377"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34377\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=34377"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=34377"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=34377"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}