{"id":21386,"date":"2013-05-29T16:00:04","date_gmt":"2013-05-29T16:00:04","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=21386"},"modified":"2013-05-29T16:00:04","modified_gmt":"2013-05-29T16:00:04","slug":"coformulated-darunavircobicistat-an-alternative-to-separate-ritonavir-boosting","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/21386","title":{"rendered":"Coformulated darunavir\/cobicistat: an alternative to separate ritonavir boosting"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>Results from a phase I cross-over study in HIV negative volunteers reported bioequivilence for a new fixed-dose formulation of darunavir\/cobicistat compared to the two compounds dosed separately.<\/strong><\/p>\n<p>Earlier studies have reported that 800 mg darunavir achieved similar PK whether boosted by 150 mg cobicistat or 100 mg.<\/p>\n<p>Least square mean (LSM) ratio values were close to 100% for both darunavir and cobicistat under both fed (high fat breakfast) and fasted conditions, with tight 90% CI values that were well within the 80%-125% range allowed for bioequivlence.<\/p>\n<p>Food increased darunavir and cobicistat Tmax similarly (approximately 4 hr fed vs 3 hr fasted) with combined and single formulations. Food significantly increased (LSM ratio) darunavir Cmax by 227% and AUC by 70% compared to fasted state, with little impact of food on cobicistat levels.<\/p>\n<p>The collaboration between Janssen and Gilead (who manufacture cobicistat) to enable a coformulated boosted-PI will also be used in single-tablet fixed-dose combinations that include Gilead&#8217;s NRTIs.<\/p>\n<p>Reference:<\/p>\n<p>Kakuda TN et al. Bioequivalence of darunavir\/cobicistat fixed-dose combination (FDC) versus single agents in healthy volunteers. 14th International Workshop on Clinical Pharmacology. 22-24 April 2013. Amsterdam. Poster abstract P_10.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base Results from a phase I cross-over study in HIV negative volunteers reported bioequivilence for a new fixed-dose formulation of darunavir\/cobicistat compared to the two compounds dosed separately. Earlier studies have reported that 800 mg darunavir achieved &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,34],"tags":[174],"class_list":["post-21386","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-pk-and-drug-interactions","tag-pk-workshop-14th-2013"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21386","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=21386"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21386\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=21386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=21386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=21386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}