{"id":39465,"date":"2020-12-09T07:38:07","date_gmt":"2020-12-09T07:38:07","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39465"},"modified":"2020-12-10T15:15:46","modified_gmt":"2020-12-10T15:15:46","slug":"new-formulation-of-dolutegravir-will-make-modern-art-available-for-babies-and-young-children-at-less-than-120-a-year","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39465","title":{"rendered":"New formulation of dolutegravir will make modern ART available for babies and young children at less than $120 a year"},"content":{"rendered":"
<\/div>\n

Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n

The much-anticipated 10 mg, dispersible, scored, strawberry-flavoured, paediatric formulation of dolutegravir \u00a0will soon be available to low- and middle-income countries, through a price agreement from Unitaid and CHAI with generic manufacturers Viatris and Macleods. [1, 2]<\/span><\/b><\/p>\n

As well as providing greatly-improved HIV treatment this will significantly reduce the annual lower cost for paediatric ART from over $480 per child to under $120 per child.<\/span><\/b><\/p>\n

The pricing agreement means the new dolutegravir formulation will be launched at a yearly cost of $36 per child, reduced from about $400.<\/p>\n

This partnership between Unitaid, CHAI and ViiV Healthcare, together with Mylan (now a subsidiary of the newly-formed Viatris), has led to the fastest regulatory approval under the US FDA PEPFAR programme of a generic paediatric HIV drug to date.<\/span><\/p>\n

CHAI also estimates that the agreement will result in significant savings for health budgets \u2013 in the region of US $60\u2013260 million over five years.<\/p>\n

The first FDA tentative approval of paediatric dispersible DTG product from Viatris was 19 November 2020. [3] Tentative approval for Macleods\u2019 product is anticipated in early 2021.<\/p>\n

The product will initially be made available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021, with plans for rapid scale-up across a number of countries.<\/p>\n

References<\/p>\n

    \n
  1. CHAI press release. Groundbreaking agreement reduces by 75% the cost of HIV treatment for children in low-and middle-income countries. 30 November 2020.
    \nhttps:\/\/www.clintonhealthaccess.org\/groundbreaking-agreement-reduces-by-75-the-cost-of-hiv-treatment-for-children-in-low-and-middle-income-countries\/<\/a><\/li>\n
  2. CHAI. Five things you should know about pediatric DTG. 30 November 2020.
    \n    https:\/\/www.clintonhealthaccess.org\/five-things-you-should-know-about-pediatric-dtg<\/a><\/li>\n
  3. US FDA. PEPFAR database. Dolutegravir tablets for oral suspension. NDA 214521. 19 November 2020.
    \n    https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=pepfar.page<\/a><\/li>\n<\/ol>\n

    This report was first posted on 1 December 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Polly Clayden, HIV i-Base The much-anticipated 10 mg, dispersible, scored, strawberry-flavoured, paediatric formulation of dolutegravir \u00a0will soon be available to low- and middle-income countries, through a price agreement from Unitaid and CHAI with generic manufacturers Viatris and Macleods. [1, 2] …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,38,32],"tags":[],"class_list":["post-39465","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-treatment-access","category-paediatric-care"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39465","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=39465"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39465\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39465"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39465"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39465"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}