{"id":29697,"date":"2016-03-22T09:11:10","date_gmt":"2016-03-22T09:11:10","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=29697"},"modified":"2016-08-25T10:21:10","modified_gmt":"2016-08-25T10:21:10","slug":"new-taf-containing-single-pill-combination-approved-in-the-us","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/29697","title":{"rendered":"New TAF-containing fixed dose combination approved in the US"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

On 1st March 2016, the U.S Food and Drug Administration (FDA) approved a new fixed-dose combination (FDC) for adults and adolescents (older than 12 years) that contains a new formulation of tenofovir DF.<\/strong><\/p>\n

The FDC contains rilpivirine (25 mg), emtricitabine (200 mg) and tenofovir alafenamide (TAF) (25 mg). The indication is for initial treatment in people with viral load <100,000 copies\/mL.<\/p>\n

It is also indicated as a switch treatment for people on stable treatment with undetectable viral load (<50 copies\/mL) for more than six months, who do not have a history of previous treatment failure.<\/p>\n

Both indications are dependent on not having drug resistance associated with any of the three drugs.<\/p>\n

As with other rilpivirine-containing combinations, this FDC also needs to be taken with a meal (>400 kcal).<\/p>\n

It is not recommended in patients with CrCl <30 mL\/min.<\/p>\n

This FDC is manufactured by Gilead and has the brand name Odefsey. The original manufacturers of rilpivirine, Janssen, will have marketing rights in 17 countries.<\/p>\n

Please see prescribing information for further details. [2, 3]<\/p>\n

Comment<\/h3>\n

A decision on approval in the EU is expected by 3Q2016.<\/strong><\/p>\n

Last week, the European Medicines Agency (EMA) announced a positive opinion on the two-drug combination of emtricitabine plus TAF, with expected full approval within a few months.<\/strong> [4]<\/p>\n

References:<\/p>\n

    \n
  1. Gilead press release. U.S. Food and Drug Administration approves Gilead’s second TAF-based single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV-1 infection. (01 March 2016)
    \nhttp:\/\/investors.gilead.com\/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2144886<\/a><\/li>\n
  2. Patient Information ODEFSEY (oh-DEF-see) (emtricitabine, rilpivirine and tenofovir alafenamide) tablets
    \n    http:\/\/www.gilead.com\/~\/media\/files\/pdfs\/medicines\/hiv\/odefsey\/odefsey_patient_pi.pdf<\/a><\/li>\n
  3. Gilead. Odefsey hightlights of prescribing information.
    \n    http:\/\/www.gilead.com\/~\/media\/files\/pdfs\/medicines\/hiv\/odefsey\/odefsey_pi.pdf<\/a><\/li>\n
  4. Gilead press release. European CHMP adopts positive opinion for Gilead’s fixed-dose combination Descovy (emtricitabine\/tenofovir alafenamide) for the treatment of HIV. (26 February 2016).
    \n    http:\/\/www.gilead.com\/news\/press-releases\/2016\/2\/european-chmp-adopts-positive-opinion-for-gileads-fixeddose-combination-descovy-emtricitabinetenofovir-alafenamide-for-the-treatment-of-hiv<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 1st March 2016, the U.S Food and Drug Administration (FDA) approved a new fixed-dose combination (FDC) for adults and adolescents (older than 12 years) that contains a new formulation of tenofovir DF. The FDC contains …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-29697","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29697","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=29697"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29697\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=29697"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=29697"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=29697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}