{"id":54097,"date":"2026-06-23T18:54:31","date_gmt":"2026-06-23T18:54:31","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=54097"},"modified":"2026-06-24T03:36:03","modified_gmt":"2026-06-24T03:36:03","slug":"applications-for-paediatric-dolutegravir-to-be-expanded-to-newborns-from-birth","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/54097","title":{"rendered":"FDA and EMA applications to expand dolutegravir to newborns from birth"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 22 June 2026, applications were submitted to both the US FDA and European Medicines Agency (EMA) to expand the indications for dolutegravir and a paediatric formulation of dolutegravir.<\/strong><\/p>\n<p>If approved, this will provide an important new treatment option for newborn babies who currently have relatively much fewer treatment options, none of which include an integrase inhibitor.<\/p>\n<p>Adult HIV treatment guidelines have recommended integrase inhibitors as initial ART for more than a decade \u2013 and now recommend using second generation INSTIs (dolutegravir or bictegravir).<\/p>\n<p>However, the current indication for paediatric dolutegravir is for babies aged four weeks or older. The indication for bictegravir is for children aged two years and older.<\/p>\n<p>The applications are supported by\u00a0<span lang=\"EN-GB\">new age-specific dosing and clinical data, including from the IMPAACT 2023 study and t<\/span>he FDA has granted the application Priority Review.<\/p>\n<p><span lang=\"EN-GB\">The paediatric formulation of dolutegravir is marketed as Tivicay PD and dolutegravir is marketed as Tivicay.<\/span><\/p>\n<p>Reference<\/p>\n<p>ViiV Press Release.\u00a0ViiV Healthcare advances paediatric HIV regulatory submissions with FDA\u202fPriority\u202fReview for Tivicay PD and\u202fEMA\u202fvalidation\u202fof marketing application\u202ffor\u202fTivicay. (22 June 2026).<br \/>\n<a href=\"https:\/\/viivhealthcare.com\/hiv-news-and-media\/news\/press-releases\/2026\/june\/marketing-application-for-tivicay\/\">https:\/\/viivhealthcare.com\/hiv-news-and-media\/news\/press-releases\/2026\/june\/marketing-application-for-tivicay<\/a><\/p>\n<div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 22 June 2026, applications were submitted to both the US FDA and European Medicines Agency (EMA) to expand the indications for dolutegravir and a paediatric formulation of dolutegravir. If approved, this will provide an important &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,32],"tags":[],"class_list":["post-54097","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-paediatric-care"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54097","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=54097"}],"version-history":[{"count":5,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54097\/revisions"}],"predecessor-version":[{"id":54102,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54097\/revisions\/54102"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=54097"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=54097"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=54097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}