{"id":15936,"date":"2011-12-01T12:29:54","date_gmt":"2011-12-01T12:29:54","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15936"},"modified":"2011-12-01T12:29:54","modified_gmt":"2011-12-01T12:29:54","slug":"rilpivirine-edurant-and-rilpivirineftctenofovir-fdc-eviplera-approved-in-europe","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15936","title":{"rendered":"Rilpivirine (Edurant) and rilpivirine\/FTC\/tenofovir FDC (Eviplera) approved in Europe"},"content":{"rendered":"

In September 2011 the EMA recommended for approval for the NNRTI rilpivirine and a fixed dose combination (FDC) of a single pill formulation of rilpivirine\/teneofovir\/FTC. Approval has now been confirmed for rilipivirine and the 3-in1 FDA, which were launched in the UK on 1 December 2011.<\/p>\n

Rilpvirine (tradename Edurant) has a European indication for use as part of a combination for treatment-na? patients with viral load <100,000 copies\/mL.<\/p>\n

The 25mg tablet must be taken with food and in Phase 3 studies had a tight relationship between adherence and efficacy. Low milligram medications are often vulnerable to a lower pharmacological safety buffer above the minimum effective concentration (MEC) at the end of the dosing period.<\/p>\n

The license for rilpivirine stresses that it needs to be taken at the same time each day.<\/p>\n

Additionally, patients who have experienced virological failure while taking rilpivirine can develop NNRTI cross-class resistance including to nevirapine and efavirenz.<\/p>\n

The list price for rilpivirine is \u00a3200.27 per month (for 30 tablets).<\/p>\n

A more detailed summary of the data from Phase 3 studies was included in the August edition of HTB, with announcement of approval in the US.<\/p>\n

The FDC formulation (tradename Eviplera in Europe and Complera in the US) based on a similar indication to rilpivirine.<\/p>\n

The list price for Eviplera is \u00a3618.77 for 30 tablets.<\/p>\n

References and links:<\/p>\n

    \n
  1. Patient information and Summary of Product Characteristics for Edurant will be published to the EMA website.
    \n http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/landing\/epar_search.jsp&mid=WC0b01ac058001d124<\/a><\/li>\n
  2. FDA approve new NNRTI rilpivirine (Edurant) in the US. HTB August 2011.
    \n     https:\/\/i-base.info\/htb\/15538<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    In September 2011 the EMA recommended for approval for the NNRTI rilpivirine and a fixed dose combination (FDC) of a single pill formulation of rilpivirine\/teneofovir\/FTC. Approval has now been confirmed for rilipivirine and the 3-in1 FDA, which were launched in …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-15936","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15936","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=15936"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15936\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15936"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15936"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15936"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}