{"id":1114,"date":"2009-02-10T09:17:38","date_gmt":"2009-02-10T09:17:38","guid":{"rendered":"http:\/\/localhost\/new\/htb\/?p=1114"},"modified":"2013-08-16T15:04:07","modified_gmt":"2013-08-16T15:04:07","slug":"emea-approves-once-daily-darunavirritonavir-800mg100mg-for-treatment-naive-patients-in-europe","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/1114","title":{"rendered":"EMEA approves once-daily darunavir\/ritonavir (800mg\/100mg) for treatment-naive patients in Europe"},"content":{"rendered":"<p><strong>On 3 February 2009, the European Commission approved once-daily dosing of 800 mg darunavir (Prezista) with low-dose ritonavir as part of combination therapy in treatment-na\u00efve adults.<\/strong><\/p>\n<p>The approval is based on 48-week analyses from the Artemis Study, an open label phase III trial in antiretroviral treatment na\u00efve HIV-1-infected adults which compared darunavir\/r vs. lopinavir\/r in combination with other antiretrovirals. The results showed that darunavir was non-inferior to the lopinavir\/r, (84% vs. 78% achieved viral load &lt;50 copies\/mL compared to lopinavir\/r ). The common adverse drug reactions reported of at least moderate intensity (\u2265Grade 2) in the darunavir\/r arm were<br \/>\nhypertriglyceridaemia, hypercholesterolaemia, headache, diarrhoea, nausea, and increased alanine aminotransferase.<\/p>\n<p>Darunavir was given conditional marketing authorisation by the European Commission in February 2007, and received full marketing authorisation in December 2008.<\/p>\n<p>The recommended dosing for treatment-na\u00efve adult patients is 800 mg (two 400 mg tablets) taken with 100 mg ritonavir once daily.<\/p>\n<p>For treatment-experienced adult patients, the dosing for darunavir remains 600 mg taken with 100 mg ritonavir twice daily.<\/p>\n<p>Darunavir must be taken with food and in combination with other ARVs. Darunavir is not recommended for use in patients with severe hepatic impairment.<\/p>\n<p>Source:<br \/>\nTibotec Press Release \u2018Once-daily darunavir\/r for treatment-naive adults with HIV-1 receives approval in the European Union as part of combination therapy\u2019. (3 February 2009)<\/p>\n<p><a href=\"http:\/\/www.tibotec.com\">http:\/\/www.tibotec.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 3 February 2009, the European Commission approved once-daily dosing of 800 mg darunavir (Prezista) with low-dose ritonavir as part of combination therapy in treatment-na\u00efve adults. The approval is based on 48-week analyses from the Artemis Study, an open label &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-1114","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1114","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=1114"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1114\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=1114"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=1114"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=1114"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}