{"id":31777,"date":"2017-06-26T12:18:56","date_gmt":"2017-06-26T12:18:56","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=31777"},"modified":"2017-07-21T20:08:34","modified_gmt":"2017-07-21T20:08:34","slug":"cabotegravirrilpivirine-submitted-to-ema-and-fda-as-oral-two-drug-maintenance-combination","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/31777","title":{"rendered":"Dolutegravir\/rilpivirine submitted to EMA and FDA as oral two-drug maintenance combination"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 1 June 2017, ViiV Healthcare submitted a new drug application to the US FDA for the two-drug oral combination of dolutegravir and rilpivirine.<\/strong><\/p>\n<p>This is an unusual in several respects: for combining only two drugs (rather than three or more) with and indication of maintenance treatment (ie as a switch rather than first-line combination)<\/p>\n<p>The submissions are based on the SWORD 1 and 2 studies that were presented at the 2017 Conference on Retroviruses and Opportunistic Infections in February.<\/p>\n<p>The US submission uses a priority review voucher to get an expedited review, usually within six months. Vouchers are commercially traded between companies with this one costing US$130 million.<\/p>\n<p>As separate drugs, dolutegravir is marketed as Tivicay by ViiV Healthcare and rilpivirine is marketed as Edurant by Janssen Sciences.<\/p>\n<p>Reference:<\/p>\n<p>ViiV Healthcare press statement. ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines. (01 June 2017).<\/p>\n<p><a href=\"https:\/\/www.viivhealthcare.com\/media.aspx\">https:\/\/www.viivhealthcare.com\/media.aspx<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 1 June 2017, ViiV Healthcare submitted a new drug application to the US FDA for the two-drug oral combination of dolutegravir and rilpivirine. This is an unusual in several respects: for combining only two drugs &hellip;<\/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-31777","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31777","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=31777"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31777\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=31777"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=31777"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=31777"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}