{"id":5472,"date":"2014-09-28T19:00:00","date_gmt":"2014-09-28T23:00:00","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=5472"},"modified":"2015-05-18T11:10:29","modified_gmt":"2015-05-18T15:10:29","slug":"new-fda-hiv-drug-approvals-unlikely-to-have-much-impact-unless","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/new-fda-hiv-drug-approvals-unlikely-to-have-much-impact-unless\/2014\/09\/28\/","title":{"rendered":"New FDA HIV Drug Approvals Unlikely to Have Much Impact, Unless &#8230;"},"content":{"rendered":"<p>If you&#8217;re an ID\u00a0doc based in the USA, you probably received notice last week that two new HIV drugs were approved &#8212; <a href=\"http:\/\/www.foodconsumer.org\/newsite\/Non-food\/Drug\/hiv_aids_update_-_approval_of_tybost_0925141007.html\" target=\"_blank\">cobicistat<\/a> and <a href=\"http:\/\/healthnewsmed.blogspot.com\/2014\/09\/hivaids-update-approval-of-vitekta.html\" target=\"_blank\">elvitegravir<\/a>.<\/p>\n<p>And if you&#8217;re wondering what the big deal is, welcome to the club. In fact, the Canadians beat us to the punch with more significant approval, the <a href=\"http:\/\/www.pharmiweb.com\/PressReleases\/pressrel.asp?ROW_ID=99631#.VCiNX2RdW3l\" target=\"_blank\">co-formulated darunavir\/cobicistat,<\/a> branded as\u00a0Prezcobix &#8212; which sounds like one favorite\u00a0<a href=\"http:\/\/www.weetabix.co.uk\/\" target=\"_blank\">British breakfast cereal.<\/a><\/p>\n<p>For the record, here are a few reasons why the FDA approval of elvitegravir and cobisistat will likely have little short-term effect on clinical practice:<\/p>\n<ul>\n<li>Elvitegravir is already available as part of TDF\/FTC\/EVG\/COBI.<\/li>\n<li>Cobicistat is already available as part of the same single tablet regimen.<\/li>\n<li>If not coformulated, elvitegravir alone has <a href=\"http:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(11)70249-3\/abstract\" target=\"_blank\">no major advantages over raltegravir <\/a>and dolutegravir<a href=\"http:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(11)70249-3\/abstract\" target=\"_blank\">.<\/a><\/li>\n<li>If not coformulated, cobicistat alone has <a href=\"http:\/\/jid.oxfordjournals.org\/content\/208\/1\/32\" target=\"_blank\">no major advantages over ritonavir.<\/a> (Though I gather the pill is smaller. Haven&#8217;t seen it yet.)<\/li>\n<\/ul>\n<p>But &#8212; what if they cost less? Especially a lot less?<\/p>\n<p>Then maybe.<\/p>\n<p><center><iframe loading=\"lazy\" width=\"420\" height=\"315\" src=\"\/\/www.youtube.com\/embed\/ANzDO9ZqppY\" frameborder=\"0\" allowfullscreen><\/iframe><\/center><\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you&#8217;re an ID\u00a0doc based in the USA, you probably received notice last week that two new HIV drugs were approved &#8212; cobicistat and elvitegravir. And if you&#8217;re wondering what the big deal is, welcome to the club. In fact, the Canadians beat us to the punch with more significant approval, the co-formulated darunavir\/cobicistat, branded [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,8,10],"tags":[205,316,423],"class_list":["post-5472","post","type-post","status-publish","format-standard","hentry","category-hiv","category-patient-care","category-research","tag-cobicistat","tag-elvitegravir","tag-hiv"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5472","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=5472"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5472\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=5472"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=5472"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=5472"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}