{"id":31704,"date":"2017-06-26T12:17:11","date_gmt":"2017-06-26T12:17:11","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=31704"},"modified":"2017-07-21T20:08:34","modified_gmt":"2017-07-21T20:08:34","slug":"bictegravirftctaf-new-once-daily-integrase-based-fdc-submitted-to-us-fda","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/31704","title":{"rendered":"Bictegravir\/FTC\/TAF: new once-daily integrase-based FDC submitted to US FDA"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 12 June 2017, Gilead Sciences submitted a new drug application to the US FDA for a single tablet fixed-dose combination (FDC) of bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF).<\/strong><\/p>\n<p>Bictegravir (formerly GS-9883) is a once-daily integrase inhibitor, with mean plasma concentration more than 20 x above the IC95 at 24 hours and low intrapatient differences. It is used at low milligram dose (50 mg) leading to a small pill with TAF. Bictegravir has a plasma half-life of 18 hours, doesn&#8217;t need PK boosting and can be taken with or without food.<\/p>\n<p>Potential drug-drug interactions that affect bictegravir are likely to be dependent on inhibition or induction of both CYP3A4 and UGT1-A1 with little expected effect of bictegravir on other drugs.<\/p>\n<p>The application is based on non-inferiority results from four phase 3 studies. These include a treatment naive study compared to dolutegravir and several switch studies in people with viral suppression on current treatment.<\/p>\n<p>A similar submission to the European Medicines Agency (EMA) is planned during\u00a03Q 2017.<\/p>\n<p>Source:<\/p>\n<p>Gilead press statement. Gilead submits new drug application to U.S. food and drug administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment. (12 June 2017).<br \/>\n<a href=\"http:\/\/www.gilead.com\/news\/press-releases\">http:\/\/www.gilead.com\/news\/press-releases<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 12 June 2017, Gilead Sciences submitted a new drug application to the US FDA for a single tablet fixed-dose combination (FDC) of bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF). Bictegravir (formerly GS-9883) is a once-daily integrase inhibitor, with mean &hellip;<\/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-31704","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31704","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=31704"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31704\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=31704"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=31704"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=31704"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}