{"id":44528,"date":"2022-12-01T07:28:43","date_gmt":"2022-12-01T07:28:43","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=44528"},"modified":"2022-12-21T10:22:45","modified_gmt":"2022-12-21T10:22:45","slug":"eu-to-recommend-approval-of-dispersible-dolutegravir-fdc-for-children-weighing-14-to-25-kg","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/44528","title":{"rendered":"EU recommends approval of dispersible abacavir\/lamivudine\/dolutegravir FDC for children weighing 14 to >25 kg"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 16 December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to approve Triumeq PD as a dispersible fixed dose combination (FDC) for children weighing 14 to <25 kg. [1]<\/span><\/strong><\/p>\n<\/div>\n

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The committee also lowered the minimum weight for using the adult non-dispersible tablet from 40 kg to 25 kg.<\/span><\/p>\n<\/div>\n

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Triumeq PD is a dispersible tablet formulation of the fixed dose combination of abacavir, \u00a0lamivudine and doluteravir. <\/span><\/p>\n<\/div>\n

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This dispersible formula<\/span>tion was approved by the US FDA in March 2022. [2]<\/b><\/span><\/p>\n

comment<\/h3>\n

Paediatric HIV remains one of the global areas of unmet need.\u00a0<\/strong>Only 52% of children (880k\/1.3 million) are on ART and only 40% on ART are undetectable. [3]<\/strong><\/p>\n

WHO-preferred first-line ART is already ViiV’s fixed dose dispersible paediatric formulation of abacavir\/lamivudine\/dolutegravir (pALD), given without genetic HLA testing for abacavir hypersensitivity. This is approved for weight 10 to 25 kg, with a plan to file for 6 kg lower weight. The US\u00a0<\/strong>FDA approved different weight eligibility to the EU (down to 10 kg in US).<\/strong><\/p>\n

Originator products are rarely introduced in LMIC but CHAI and ViiV are working with generic manufacturers. Last I heard was filings are expected in the new year + tentative approval mid 2023. [3]<\/strong><\/p>\n

Given the wide use of dual ART without abacavir, the D3 study (PENTA 21)\u00a0is also investigating DTG\/3TC in children.
\n<\/strong>https:\/\/penta-id.org\/hiv\/d3<\/a><\/strong><\/p>\n<\/div>\n

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Reference<\/span><\/p>\n<\/div>\n

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    \n
  1. ViiV press release. ViiV Healthcare announces CHMP positive opinion for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV in Europe. (16 December 2022).
    \n    viivhealthcare.com\/hiv-news-and-media\/news\/press-releases\/2022\/december\/viiv-healthcare-announces-chmp-positive-opinion-for-triumeq-pd<\/a><\/span><\/li>\n
  2. FDA approves dispersible dolutegravir\/abacavir\/3TC for children. HTB May 2022.
    \n    i-base.info\/htb\/42815<\/a><\/li>\n
  3. CHAI. Highlighting the latest updates in HIV treatment, prevention, and diagnostics\n
    https:\/\/www.clintonhealthaccess.org\/webinar\/2022-hiv-market-report<\/a> (report )<\/div>\n
    https:\/\/www.youtube.com\/watch?v=GKay_ifczWE&t=70s<\/a> (webinar)<\/div>\n
    <\/div>\n<\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 16 December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to approve Triumeq PD as a dispersible fixed dose combination (FDC) for children …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,32],"tags":[],"class_list":["post-44528","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\/44528","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=44528"}],"version-history":[{"count":14,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44528\/revisions"}],"predecessor-version":[{"id":44624,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44528\/revisions\/44624"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=44528"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=44528"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=44528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}