{"id":30988,"date":"2016-11-29T09:16:21","date_gmt":"2016-11-29T09:16:21","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=30988"},"modified":"2016-11-29T18:04:17","modified_gmt":"2016-11-29T18:04:17","slug":"fda-approves-maraviroc-for-children-aged-two-and-older","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/30988","title":{"rendered":"FDA approves maraviroc for children aged two and older"},"content":{"rendered":"

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

On 4 November 2016, ViiV Healthcare received approval from the US Food and Drug Administration (FDA) for maraviroc to treat CCR5-tropic HIV in combination with other antiretrovirals in paediatric patients two years old and above weighing at least 10 kg.<\/strong> [1]<\/p>\n

Maraviroc is not recommended in patients with dual\/mixed- or CXCR4-tropic HIV.<\/p>\n

New 25 mg and 75 mg tablets and a 20 mg\/mL oral solution will be available in the US January 2017. The paediatric dose is based on body weight and the potential for drug-drug interactions with other medicines.<\/p>\n

The FDA approval is based on results of an open-label trial in which 103 treatment-experienced paediatric patients with only CCR5-tropic HIV, aged 2 to 18 years and weighing at least 10 kg, received maraviroc twice daily in combination with optimised background therapy. [2]<\/p>\n

At 48 weeks, 48% of patients achieved viral load less than 48 copies\/mL and 65% viral load less than 400 copies\/mL. The mean CD4 count increase from baseline to week 48 was 247 cells\/mm3.<\/p>\n

In the study, the dose was based on body surface area and whether or not the patient was receiving potent cytochrome P450 3A inhibitors and\/or inducers.<\/p>\n

The safety profile of maraviroc through 96 weeks was similar to that for adults.<\/p>\n

US prescribing information for maraviroc has been updated accordingly. [3]<\/p>\n

Comment<\/h3>\n

In contrast to most current paediatric antiretrovirals that take an age-staggered approach to approvals – this one included children and adolescents aged 2-18 years.<\/strong><\/p>\n

As with adults, widespread use of maraviroc is not expected.<\/strong><\/p>\n

References:<\/p>\n

    \n
  1. ViiV Healthcare press release: ViiV Healthcare announces FDA approval of Selzentry (maraviroc) for use in children and adolescents living with HIV. 4 November 2016.
    \nhttps:\/\/www.viivhealthcare.com\/media\/press-releases\/2016\/october\/viiv-healthcare-announces-fda-approval-of-selzentry-maraviroc-for-use-in-children-and-adolescents-living-with-hiv.aspx<\/a><\/li>\n
  2. US National Institutes of Health. An open label pharmacokinetic, safety and efficacy study of maraviroc in combination with background therapy for the treatment of HIV-1 infected, CCR5-tropic children.
    \n    https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00791700<\/a><\/li>\n
  3. Selzentry (maraviroc) US prescribing information.
    \n    https:\/\/www.gsksource.com\/pharma\/content\/dam\/GlaxoSmithKline\/US\/en\/Prescribing_Information\/Selzentry\/pdf\/SELZENTRY-PI-MG.PDF<\/a>\u00a0(PDF)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Polly Clayden, HIV i-Base On 4 November 2016, ViiV Healthcare received approval from the US Food and Drug Administration (FDA) for maraviroc to treat CCR5-tropic HIV in combination with other antiretrovirals in paediatric patients two years old and above weighing …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,32],"tags":[],"class_list":["post-30988","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\/30988","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=30988"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30988\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=30988"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=30988"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=30988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}