{"id":16643,"date":"2012-06-01T11:30:02","date_gmt":"2012-06-01T11:30:02","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=16643"},"modified":"2012-07-21T05:41:53","modified_gmt":"2012-07-21T05:41:53","slug":"fda-advisory-hearing-supports-approval-of-tenofovirftc-for-prep","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/16643","title":{"rendered":"FDA advisory hearing supports approval of tenofovir\/FTC for PrEP"},"content":{"rendered":"<p><strong>On 10 May 2012, US FDA Antiviral Drugs Advisory Committee held an open meeting to decide on recommendations for approval for tenofovir\/FTC (Truvada) to have an indication for use as Pre-Exposure Prophylaxis (PrEP) to reduce the risk of HIV transmission.<\/strong><\/p>\n<p>The meeting lasted more than 12 hours, and involved the panel voting on key questions.<\/p>\n<p>This included a 19:3 vote in favour of recommending approval for men who have sex with men (MSM) at risk for HIV; and a vote of 19:2 (with one abstention) for recommending approval for HIV negative partners in relationships with HIV positive partners. The vote was closer for a general use to reduce sexual transmission with 12:8 in favour (with 2 abstentions).<\/p>\n<p>While the FDA are not mandated to follow the panel recommendations, it is unusual for this not to happen. The final approval decision is expected by 15 June.<\/p>\n<p>As part of this process, the FDA publish a briefing document prior to each advisory panel meeting, available in PDF format online, which compiles a review of the data.<\/p>\n<p>Links and further information:<\/p>\n<p>FDA briefing document (PDF)<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/AntiviralDrugsAdvisoryCommittee\/UCM303213.pdf\">http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/<br \/>\nDrugs\/AntiviralDrugsAdvisoryCommittee\/UCM303213.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>May 2012: FDA Antiviral Drugs Advisory Committee recommends tenofovir\/FTC (Truvada)  be indicated for PrEP<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-16643","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16643","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=16643"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16643\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=16643"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=16643"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=16643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}