{"id":4408,"date":"2009-08-22T12:40:34","date_gmt":"2009-08-22T11:40:34","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=4408"},"modified":"2013-08-16T13:21:12","modified_gmt":"2013-08-16T13:21:12","slug":"raltegravir-approved-in-the-us-for-treatment-naive-patients-paranoia-and-anxiety-added-as-side-effects","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/4408","title":{"rendered":"Raltegravir approved in the US for treatment-naive patients: paranoia and anxiety added as side effects"},"content":{"rendered":"<p><strong>On 8 July 2009, the US FDA granted approval for raltegravir (Isentress), to be used in treatment-naive patients. The recommended dose for raltegravir is 400 mg twice daily, with or without food.<\/strong><\/p>\n<p>This expanded use in treatment-naive patients is based on 48-week results of a randomised, double-blind trial comparing raltegravir to efavirenz, both with tenofovir+FTC backgroung nucleosides. Viral load was reduced to &lt;50 copies\/mL in 87% of the raltegravir group compared to 82% of the efavirenz group (difference 4.7% 95% CI -1.3%, 10.6%).<\/p>\n<p>Other changes were made to the US package insert included new reference to paranoia and anxiety as newly repirted side effects.<\/p>\n<p><strong>DRUG INTERACTIONS<\/strong> Together with a warning about use with UGT (UDP-glucuronosyltransferases) inducers other than rifampin, specifically, \u0093Coadministration of raltegravir with drugs that are strong inducers of UGT1A1 may result in reduced plasma concentrations of raltegravir\u0094<\/p>\n<p><strong>SIDE EFFECTS<\/strong> Section 6.2: <strong>Postmarketing experience:<\/strong> the addition of paranoia and anxiety.<\/p>\n<p><strong>DRUG INTERACTIONS<\/strong> Section 7.1 <strong>Effect of raltegravir on the pharmacokinetics of other agents<\/strong> adds information for CYP1A2, CYP2B6 and methadone.<\/p>\n<p><strong>RESISTANCE:<\/strong> Treatment-naive subjects: By Week 48 in the STARTMRK trial, the primary raltegravir resistance-associated substitutions were observed in 3 (1 with Y143R and 2 with Q148H\/R) of the 6 virologic failure subjects with evaluable paired genotypic data.<\/p>\n<p>Minor editorial changes were made to the patient package insert for consistency with other antiretrovirals.<\/p>\n<p>The revised label will be available on the FDA web site:<\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm<\/a><\/p>\n<p>or through the National Library of Medicine\u0092s DailyMed site:<\/p>\n<p><a href=\"http:\/\/dailymed.nlm.nih.gov\/dailymed\/about.cfm\">http:\/\/dailymed.nlm.nih.gov\/dailymed\/about.cfm<\/a><\/p>\n<p>Source: FDA listserve (09 July 2009)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 8 July 2009, the US FDA granted approval for raltegravir (Isentress), to be used in treatment-naive patients. The recommended dose for raltegravir is 400 mg twice daily, with or without food. This expanded use in treatment-naive patients is based &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-4408","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4408","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=4408"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4408\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=4408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=4408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=4408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}