{"id":36725,"date":"2019-10-18T08:21:11","date_gmt":"2019-10-18T08:21:11","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36725"},"modified":"2019-10-21T11:59:19","modified_gmt":"2019-10-21T11:59:19","slug":"dual-dolutegravir-lamivudine-submitted-to-us-fda-as-switch-option","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36725","title":{"rendered":"Dual dolutegravir\/lamivudine submitted to US FDA as switch option"},"content":{"rendered":"<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\">Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">On 16 October 2019, ViiV Healthcare reported that the company had submitted a supplemental new drug application to the US FDA to use dolutegravir\/lamivudine as a switch options for adults with undetectable viral load on their current combination. [1]<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This is based on results from the phase 3 TANGO study, reported at IAS 2019. [2, 3]<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The current indication, both in the EU and the US is for use as initial ART in people without resistance to either drug.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The fixed dose combination (FDC) of dolutegravir is marketed with the trade name Dovato.<\/span><\/p>\n<p class=\"HTBreferences\"><span lang=\"EN-US\">References<\/span><\/p>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">ViiV Healthcare press statement. ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1 (16 October 2019).<br \/>\n<\/span><a href=\"https:\/\/viivhealthcare.com\/en-gb\/media\/press-releases\/2019\/october\/viiv-healthcare-submits-supplemental-new-drug-application-to-us-\" rel=\"noopener\">https:\/\/viivhealthcare.com\/en-gb\/media<\/a><\/li>\n<li class=\"HTBreferences\">van Wyk J et al. Switching to DTG+3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 24 weeks (TANGO Study). 10th IAS Conference on HIV Science (IAS 2019), 21-24 July 2019, Mexico City. Late-breaker oral abstract WEAB0403LB.<br \/>\n<a href=\"http:\/\/programme.ias2019.org\/Abstract\/Abstract\/4903\" rel=\"noopener\">http:\/\/programme.ias2019.org\/Abstract\/Abstract\/4903<\/a><\/li>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Collins S. Switching to dolutegravir\/lamivudine dual therapy is non-inferior to TAF-based triple therapy at week-48 in TANGO study. HTB (24 July 2019).<br \/>\n<\/span><a href=\"https:\/\/i-base.info\/htb\/36450\">https:\/\/i-base.info\/htb\/36450<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 16 October 2019, ViiV Healthcare reported that the company had submitted a supplemental new drug application to the US FDA to use dolutegravir\/lamivudine as a switch options for adults with undetectable viral load on their &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-36725","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36725","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=36725"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36725\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}