{"id":38355,"date":"2020-07-22T07:35:51","date_gmt":"2020-07-22T07:35:51","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38355"},"modified":"2020-08-06T20:42:04","modified_gmt":"2020-08-06T20:42:04","slug":"fda-approves-fostemsavir-for-multidrug-resistant-hiv-in-the-us","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38355","title":{"rendered":"FDA approves fostemsavir (Rukobia) for multidrug resistant HIV in the US"},"content":{"rendered":"<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\">Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYFIRST\"><strong><span lang=\"EN-US\">On 2 July 2020, the US FDA approved fostemsavir as an HIV treatment for people with extensive drug resistance and few choices for antiretroviral treatment (ART). [1, 2]<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Fostemsavir <\/span>is a gp120 attachment inhibitor, the first drug in this new class, that works at an early stage of the HIV lifecycle to block the virus from infecting CD4 cells.<\/p>\n<p class=\"HTBBODYtext\">The indication also covers people <span lang=\"EN-US\">who are failing their current ART due to resistance, intolerance or safety considerations.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Approval was primarily based on results from the international phase 3 BRIGHTE study, which has reported 96-week follow-up, but longer term results are available from some participants out to week 192. [3, 4]<\/span><\/p>\n<p class=\"HTBBODYtext\">Fostemsavir (previously BMS-663068) has had a long development history, and was acquired by ViiV Healthcare from Bristol-Myers Squibb with other investigational compounds in 2015.<\/p>\n<p class=\"HTBBODYtext\">Fostemsavir is dosed at 600 mg twice-daily.<\/p>\n<p>Potential drug-drug interactions are possible with strong cytochrome P450 (CYP)3A inducers, would significantly reduce temsavir (the active moiety of fostemsavir) plasma concentrations. These drugs include, but are not limited:<\/p>\n<ul>\n<li>Androgen receptor inhibitor: enzalutamide<\/li>\n<li>Anticonvulsants: carbamazepine, phenytoin<\/li>\n<li>Antimycobacterial: rifampin<\/li>\n<li>Antineoplastic: mitotane<\/li>\n<li>Herbal product: St John\u2019s wort (Hypericum perforatum)<\/li>\n<\/ul>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Fostemsavir is marketed by ViiV Healthcare under the trade name Rukobia.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">For more details please see the full prescribing information. [5]<\/span><\/p>\n<p class=\"HTBcommenttitle\"><strong><span lang=\"EN-US\">COMMENT<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Although the pool of people on failing ART with multiple drug resistance is luckily small, fostemsavir In combination with other active drugs, is likely to be a life-saving option.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Fostemsavir was submitted to the EMA for approval in the EU in January 2020, with a decision expected shortly.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">A limited named patient access programme is available, including in the UK, for people who urgently need access to fostemsavir. For details, doctors should directly contact ViiV Healthcare.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">References<\/span><\/p>\n<ol>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">FDA press release. FDA approves new HIV treatment for patients with limited treatment options (2 July 2020).<br \/>\n<\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-hiv-treatment-patients-limited-treatment-options\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-hiv-treatment-patients-limited-treatment-options<\/span><\/a><\/li>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">ViiV press release. ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available. (2 July 2020).<br \/>\n<\/span><a href=\"https:\/\/viivhealthcare.com\/en-gb\/media\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/viivhealthcare.com\/en-gb\/media<\/span><\/a><\/li>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">Collins S. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB (24 July 2019).<br \/>\n<\/span><a href=\"https:\/\/i-base.info\/htb\/36390\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/i-base.info\/htb\/36390<\/span><\/a><\/li>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">Thompson M et al. Long-term safety &amp; efficacy of fostemsavir in treatment-experienced HIV participants. CROI 2019, 4 &#8211; 7 March, Seattle. Poster abstract 483.<br \/>\n<\/span><a href=\"https:\/\/www.croiconference.org\/abstract\/long-term-safety-efficacy-fostemsavir-treatment-experienced-hiv-participants\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/www.croiconference.org\/abstract\/long-term-safety-efficacy-fostemsavir-treatment-experienced-hiv-participants<\/span><\/a><\/li>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">Ruktobia US Prescribing Information. (Still to be posted).<br \/>\n<\/span><span lang=\"EN-US\"><a href=\"https:\/\/medlineplus.gov\/druginfo\/drug_Ra.html\" rel=\"noopener noreferrer\">https:\/\/medlineplus.gov\/druginfo\/drug_Ra.html<\/a> (FDA website)<br \/>\n<\/span><span lang=\"EN-US\"><a href=\"https:\/\/viivhealthcare.com\/en-us\/our-medicines\" rel=\"noopener noreferrer\">https:\/\/viivhealthcare.com\/en-us\/our-medicines<\/a> (ViiV website)<\/span><\/li>\n<\/ol>\n<p><em>This report was first published on 2 July 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 2 July 2020, the US FDA approved fostemsavir as an HIV treatment for people with extensive drug resistance and few choices for antiretroviral treatment (ART). [1, 2] Fostemsavir is a gp120 attachment inhibitor, the first &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-38355","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38355","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=38355"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38355\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38355"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38355"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38355"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}