{"id":43197,"date":"2022-07-01T07:43:37","date_gmt":"2022-07-01T07:43:37","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=43197"},"modified":"2022-07-01T08:24:04","modified_gmt":"2022-07-01T08:24:04","slug":"lenacapavir-for-mdr-hiv-gets-positive-opinion-for-approval-in-the-eu","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/43197","title":{"rendered":"Lenacapavir gets positive opinion for approval in the EU to treat MDR HIV"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 24 June 2022, the CHMP recommended EU approval for lenacapavir as a treatment for people with multiple drug resistance to other HIV drugs. [1]<\/span><\/strong><\/p>\n<\/div>\n

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This is based on 26-week results from the CAPELLA study that were recently published in the NEJM (and presented at CROI 2022 and EACS 2021). [2]<\/span><\/p>\n<\/div>\n

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Lenacapavir is a capsid inhibitor given by subcutaneous injection every six months.<\/span><\/p>\n<\/div>\n

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Positive opinions from the CHMP are routinely given full approval in the EU within three months.<\/span><\/p>\n<\/div>\n

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comment<\/span><\/h3>\n<\/div>\n
This is good news – and the first example of an ARV first being approved with an MDR indication.<\/span><\/strong><\/div>\n

Lenacapavir needs to be used in combination with other HIV drugs that are active. As monotherapy, it has a low genetic barrier to drug resistance which will quickly lead to loss of this new class.<\/span><\/strong><\/p>\n

Cases of viral failure in the CAPELLA study resulted from low adherence to oral ART in the optimised background regimen.<\/span><\/strong><\/p>\n

A decision from the US FDA is also expected shortly as Gilead also announced that an issue relating to manufacturing and storage has also been resolved. [3, 4]<\/span><\/strong><\/p>\n

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References<\/p>\n<\/div>\n

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    \n
  1. Gilead press release. <\/span>Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV. (24 June 2022).
    \nhttps:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2022\/6\/investigational-lenacapavir-receives-positive-chmp-opinion-for-people-with-multi-drug-resistant-hiv<\/a><\/li>\n
  2. Lenacapavir in MDR HIV: phase 3 results of CAPELLA study published. HTB (! June 2022).
    \n    https:\/\/i-base.info\/htb\/42883<\/a><\/li>\n
  3. Lenacapavir submitted to EMA for MDR HIV. HTB (17 September 2021).
    \n    https:\/\/i-base.info\/htb\/41294<\/a><\/li>\n
  4. Gilead <\/b>resubmits new drug application to US Food and Drug Administration for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor. (27 June 2022).
    \n    https:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2022\/6\/gilead-resubmits-new-drug-application-to-us-food-and-drug-administration-for-lenacapavir-an-investigational-longacting-hiv1-capsid-inhibitor<\/a><\/li>\n<\/ol>\n<\/div>\n
    \n

    This report was first published on 24 June 2022.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 24 June 2022, the CHMP recommended EU approval for lenacapavir as a treatment for people with multiple drug resistance to other HIV drugs. [1] This is based on 26-week results from the CAPELLA study that …<\/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-43197","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43197","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=43197"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43197\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=43197"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=43197"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=43197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}