{"id":36656,"date":"2019-09-30T08:37:22","date_gmt":"2019-09-30T08:37:22","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36656"},"modified":"2019-09-30T13:12:11","modified_gmt":"2019-09-30T13:12:11","slug":"fda-expands-indication-for-doravirine-in-the-us-as-switch-option","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36656","title":{"rendered":"FDA expands indication for doravirine in the US as switch option"},"content":{"rendered":"<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">Simon Collins, HIV i-Base<\/span><\/b><\/p>\n<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">On 20 September 2019, the US FDA expanded the indication for the NNRTI doravirine to also include people currently on effective ART with undetectable viral load. [1]<\/span><\/b><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Similar approval was also announced for the fixed dose combination (FDC) of doravirine\/TDF\/3TC.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Previously, doravirine was indicated as first-line ART for people who were treatment-naive.<\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Approvals were based on results from the phase 3 DRIVE-SHIFT trial that switched people on stable ART to the fixed dose combination (FDC) of doravirine\/3TC\/TDF (Delstrigo). <\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">This study was published as an open access paper in the 1 August 2019 edition of JAIDS. [2]<\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Reference<\/span><\/p>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Merck PR. Merck\u2019s doravirine (Pifeltro) and doravirine\/lamivudine\/tenofovir disoproxil fumarate (Delstrigo) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed. 20 September 2019).<br \/>\n<a href=\"https:\/\/www.mrknewsroom.com\/news-release\/prescription-medicine-news\/mercks-pifeltro-doravirine-and-delstrigo-doravirinelamivudin\" rel=\"noopener\">https:\/\/www.mrknewsroom.com\/news-release\/prescription-medicine-news\/mercks-pifeltro-doravirine-and-delstrigo-doravirinelamivudin<\/a><br \/>\n<\/span><\/li>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Johnson M et al. <\/span>Switching to\u00a0doravirine\/lamivudine\/tenofovir disoproxil fumarate (DOR\/3TC\/TDF) maintains\u00a0HIV-1\u00a0virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. <span lang=\"EN-US\">JAIDS: 81(4); 463\u2013472. doi: 10.1097\/QAI.0000000000002056.<br \/>\n<\/span><a href=\"https:\/\/journals.lww.com\/jaids\/Fulltext\/2019\/08010\/Switching_to_Doravirine_Lamivudine_Tenofovir.15.aspx\" rel=\"noopener\">https:\/\/journals.lww.com\/jaids\/Fulltext\/2019\/08010\/Switching_to_Doravirine_Lamivudine_Tenofovir.15.aspx<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 20 September 2019, the US FDA expanded the indication for the NNRTI doravirine to also include people currently on effective ART with undetectable viral load. [1] Similar approval was also announced for the fixed dose &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-36656","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36656","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=36656"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36656\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36656"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36656"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36656"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}