{"id":21240,"date":"2013-04-01T12:11:36","date_gmt":"2013-04-01T12:11:36","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=21240"},"modified":"2013-04-03T09:20:08","modified_gmt":"2013-04-03T09:20:08","slug":"dietary-requirements-changed-in-europe-for-fixed-dose-combination-rilpivirinetenofovirftc-eviplera","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/21240","title":{"rendered":"Dietary requirements changed in Europe for fixed dose combination rilpivirine\/tenofovir\/FTC (Eviplera)"},"content":{"rendered":"<p><strong>On 20 March 2013, Gilead isseud a letter noting that the European Medicines Agency (EMA) had modified the Summary of Product Characteristics (SPC) for the fixed dose combination rilpivirine\/tenofovir\/FTC (Eviplera).<\/strong> [1]<\/p>\n<p>The new recommendation is to take Eviplera &#8220;with food&#8221;. Previously the indication was &#8220;take with a meal&#8221; (See Section 4.2 in the SPC). [2]<\/p>\n<p>This was based on a review of results from a pharmacokinetic study that was presented at the Glasgow conference, reporting a slightly different impact of food on rilpivirine absorption when part of the fixed dose combination Eviplera compared to when taken as a separate medication. [3]<\/p>\n<p>This study reported that rilpivirine and tenofovir exposure are increased after intake of a standard (533 kcal, 21 g fat) or light meal (390 kcal, 12 g fat) relative to fasting conditions. Compared to fasting conditions, rilpivirine AUC was 9% and 16% higher with a light meal or standard meal, respectively. Compared to standard meal, RPV AUC was 14% and 6% lower with fasted or light meal administration, respectively. These details have not been added to Section 5.2 of the SPC on pharmacokinetic proterties.<\/p>\n<p>These changes only relate to the prescribing information with regard to food intake for the FDC formulation. The SPC for single agent rilpivirine still retains the requirement to take with a standard (533 kcal) meal.<\/p>\n<p>References:<\/p>\n<ol>\n<li>Gilead letter to treatment educators. Changes to food Eviplera. 20 March 2013. 188\/IHQ\/13-03\/\/1074.<\/li>\n<li>Kearney B et al. Effect of food on the pharmacokinetics of emtricitabine\/ rilpivirine\/tenofovir disoproxil fumarate single-tablet regimen. 11th International HIV Congress, 11-15 November 2012. Journal of the International AIDS Society 2012, 15(Suppl 4):18333. Poster abstract P68.<br \/>\n<a href=\"http:\/\/dx.doi.org\/10.7448\/IAS.15.6.18333\">http:\/\/dx.doi.org\/10.7448\/IAS.15.6.18333<\/a><\/li>\n<li>Eviplera: Summary of Product Characteristics, (updated 13 February 2013).<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/002312\/human_med_001514.jsp&amp;mid=WC0b01ac058001d124\">http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/002312\/human_med_001514.jsp&amp;mid=WC0b01ac058001d124<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>On 20 March 2013, Gilead isseud a letter noting that the European Medicines Agency (EMA) had modified the Summary of Product Characteristics (SPC) for the fixed dose combination rilpivirine\/tenofovir\/FTC (Eviplera). [1] The new recommendation is to take Eviplera &#8220;with food&#8221;. &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,34],"tags":[],"class_list":["post-21240","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-pk-and-drug-interactions"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21240","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=21240"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21240\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=21240"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=21240"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=21240"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}