{"id":34203,"date":"2018-06-08T10:40:34","date_gmt":"2018-06-08T10:40:34","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=34203"},"modified":"2018-06-08T15:10:47","modified_gmt":"2018-06-08T15:10:47","slug":"ema-approves-dolutegravirrilpivirine-juluca-in-europe-as-dual-therapy-hiv-switch-option","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/34203","title":{"rendered":"EMA approves dolutegravir\/rilpivirine (Juluca) in Europe as dual-therapy HIV switch option"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 21 May 2018, the oral fixed dose combination (FDC) of dolutegravir\/rilpivirine was approved by the EU as a switch option for people stable on ART for more than six months. The indication also includes no history of treatment failure or drug resistance.<\/strong><\/p>\n<p>The fixed dose combination is notable for only containing two active drugs, and for being an NRTI-free combination.<\/p>\n<ul>\n<li>Standard adult dose is once pill, once daily.<\/li>\n<li>Juluca needs to be taken with food (to boost the rilpivirine).<\/li>\n<li>A drug interaction with the TB medicine rifabutin requires taking an additional daily 25 mg rilpivirine tablet.<\/li>\n<li>Other drug interactions mean that Juluca should not be taken with the following drugs:\u00a0dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (including: esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole), St. John&#8217;s wort, or more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate,<\/li>\n<li>No dose adjustment is needed with mild or moderate kidney damage (defined as CrCl greater than 30mL\/min). Increased monitoring is recommended in more severe kidney damage (CrCl less than 30mL\/min).<\/li>\n<li>No dose adjustment is needed with mild or moderate liver damage.<\/li>\n<\/ul>\n<p>This FDC is a collaboration between ViiV Healthcare (dolutegravir) and Janssen Pharmaceutical (rilpivirine) and is marketed under the brand name Juluca.<\/p>\n<p>Juluca was approved in the US in November 2017.<\/p>\n<p>For further details please see the full prescribing information.<\/p>\n<h3>comment<\/h3>\n<p><strong>Although Juluca has been launched in the UK, access will depend on different NHS procedures by the NHS in each country.\u00a0<\/strong><\/p>\n<ul dir=\"ltr\">\n<li><strong>Scotland. Juluca has been submitted to the SMC with an anticipated reimbursement decision by September\/October 2018. <\/strong><\/li>\n<li><strong>Northern Ireland has similar timing to NHS Scotland &#8211; expected\u00a0September\/October 2018.<\/strong><\/li>\n<li><strong>England. Timing is more difficult to predict based on the timeline of the\u00a0specialised commissioning process. Expect early 2019.<\/strong><\/li>\n<li><strong>Wales. Timing still to be confirmed.<\/strong><\/li>\n<\/ul>\n<p>Reference<\/p>\n<ol>\n<li>ViiV press statement, ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir\/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV. (21 May 2018).<br \/>\n<a href=\"https:\/\/www.viivhealthcare.com\/media\/\">https:\/\/www.viivhealthcare.com\/media<\/a> (media page)<br \/>\n<a href=\"https:\/\/www.viivhealthcare.com\/media\/press-releases\/2018\/may\/viiv-healthcare-receives-eu-marketing-authorisation-for-juluca-dolutegravirrilpivirine-the-first-2-drug-regimen-once-daily-single-pill-for-the-treatment-of-hiv.aspx\">https:\/\/www.viivhealthcare.com\/media\/press-releases\/2018\/may\/viiv-healthcare-receives-eu-marketing-authorisation-for-juluca-dolutegravirrilpivirine-the-first-2-drug-regimen-once-daily-single-pill-for-the-treatment-of-hiv.aspx<\/a> (direct link)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 21 May 2018, the oral fixed dose combination (FDC) of dolutegravir\/rilpivirine was approved by the EU as a switch option for people stable on ART for more than six months. The indication also includes no &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-34203","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34203","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=34203"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34203\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=34203"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=34203"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=34203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}