{"id":38225,"date":"2020-06-26T07:30:41","date_gmt":"2020-06-26T07:30:41","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38225"},"modified":"2020-06-26T09:51:06","modified_gmt":"2020-06-26T09:51:06","slug":"fda-contraindication-for-remdesivir-and-hydroxychloroquine-hcq-immediate-impact-on-current-hcq-research","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38225","title":{"rendered":"FDA contraindication for remdesivir and hydroxychloroquine (HCQ): immediate impact on current HCQ research"},"content":{"rendered":"<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\"><img loading=\"lazy\" decoding=\"async\" class=\" alignright\" src=\"https:\/\/i-base.info\/wp-content\/uploads\/2020\/03\/COVID-19-graphic.png\" width=\"231\" height=\"142\" \/>Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">On 15 June 2020, the US FDA issued a warning over a potential serious drug interaction between remdesivir and hydroxychloroquine that makes the two drugs contraindicated. [1]<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The warning is based on a recently completed study that showed that HCQ could reduce concentrations of remdesivir, although further details on the interaction are not given<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This should stop continued enrolment into ongoing HCQ studies in settings where remdesivir is available (if any such studies are still continuing).<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Access to remdesivir as a proven and approved treatment now outweighs the scientific interest in HCQ, however novel the original study design, especially given recent reports that HCQ has no activity against COVID-19. [2]<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The FDA also revoked the Emergency Use Authorisation (EUA) that was issued in March 2020 to enable access and research into HCQ for COVID-19. [3]<\/span><\/p>\n<h3 class=\"HTBBODYtext\"><span lang=\"EN-US\">comment<\/span><\/h3>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">The Liverpool Drug Interaction databases (both for HIV and COVID-19) categorise this DDI as serious with a red alert contraindication.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Ongoing HCQ studies need to rapidly consider best outcomes for their participants that will prioritise immediate access to remdesivir as an FDA-approved active drug compared to scientific interest in HCQ as an investigational drug that has now reported outcomes that are worse than standard of care (ie no intervention).<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">This should limit further randomisations to studies that include HCQ arms when remdesivir is now available.<\/span><\/strong><b><span lang=\"EN-US\">\u00a0<\/span><\/b><\/p>\n<p class=\"HTBreferences\"><span lang=\"EN-US\"><em>This article was first published online on 16 June 2020.<\/em><\/span><\/p>\n<p class=\"HTBreferences\"><span lang=\"EN-US\">References<\/span><\/p>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Coronavirus (COVID-19) update: FDA warns of newly discovered potential drug interaction that may reduce effectiveness of a COVID-19 treatment authorized for emergency use (15 June 2020).<br \/>\n<\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-warns-newly-discovered-potential-drug-interaction-may-reduce\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-warns-newly-discovered-potential-drug-interaction-may-reduce<\/span><\/a><\/li>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Collins S. UK RECOVERY study stops hydroxychloroquine (HCQ) for COVID-19: more than 1100 deaths question ethics and safety overall. HTB early access (6 June 2020).<br \/>\n<\/span><a href=\"https:\/\/i-base.info\/htb\/38188\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/i-base.info\/htb\/38188<\/span><\/a><\/li>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">FDA announcement. <\/span>Coronavirus (COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine. (15 June 2020).<br \/>\n<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and<\/a> (html)<br \/>\n<a href=\"https:\/\/www.fda.gov\/media\/138945\/download\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/media\/138945\/download<\/a> (PDF)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 15 June 2020, the US FDA issued a warning over a potential serious drug interaction between remdesivir and hydroxychloroquine that makes the two drugs contraindicated. [1] The warning is based on a recently completed study &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-38225","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38225","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=38225"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38225\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}