{"id":41890,"date":"2021-12-20T07:37:44","date_gmt":"2021-12-20T07:37:44","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41890"},"modified":"2022-02-20T08:27:00","modified_gmt":"2022-02-20T08:27:00","slug":"us-fda-approves-long-acting-cabotegravir-injections-for-prep","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41890","title":{"rendered":"US FDA approves long-acting cabotegravir injections for PrEP: price set at $22,000 a year"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 20 December 2021, the US FDA approved long-acting cabotegravir injections for pre-exposure prophylaxis (PrEP) against HIV infection. [1]<\/span><\/strong><\/p>\n<\/div>\n

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The indication is for HIV negative <\/span>adults and adolescents weighing at least 35 kg who are at risk of HIV. Dosing involves a single 600 mg (3 mL) intramuscular gluteal injection given monthly for the first two doses, and then given every two months. The use of a monthly oral lead-in period to test for sensitivity is optional.<\/p>\n<\/div>\n

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Dosing can be brought forward by up to seven days but missed injections include the recommendation to use various schedules of daily oral cabotegravir, depending on timing of missed doses.<\/p>\n<\/div>\n

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Approval is based on results from two large international randomised phase 3 studies (<\/span>HPTN 083 and 084) that used daily oral TDF\/FTC as an active control.<\/p>\n<\/div>\n

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For full details see the full product information, including for side effects, risk of developing drug resistance and that residual concentrations of cabotegravir can persist for more than a year after a single injection.<\/span><\/p>\n<\/div>\n

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Cabotegravir injections for PrEP are manufactured by ViiV Healthcare and marketed by under the trade name Apretude.<\/span><\/p>\n<\/div>\n

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Long-acting injections of both cabotegravir plus rilpivirine were approved by the FDA as HIV treatment in January 2021. [2]<\/span><\/p>\n<\/div>\n

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comment<\/h3>\n

The scientific achievement of this new option for PrEP is clearly recognised and welcomed. <\/strong><\/p>\n

But for all the potential advantages, access for most people will be linked to pricing, and the\u00a0wholesale price announced in the US is $22,000 a year.<\/strong><\/p>\n

In a press release on 23 December 2021, the US activist organisation the Fair Price Coalition has denounced the price as both exorbitant and unsustainable. It notes this price is 25% higher than when cabotegravir is used as HIV treatment. And also the the US now has access to generic oral PrEP with TDF\/FTC marketed at approximately $30 for 30 tablets. [3]<\/strong><\/p>\n

Throughout the development stages ViiV Healthcare stated many times that pricing would be easily affordable, including for people in low and middle-income countries that contributed clinical sites for the large phase 3 studies. Guaranteeing access in countries where research is run is actually an ethical requirement of the Helsinki declaration for running international studies.<\/strong><\/p>\n

This would involve setting a price in these countries that is comparable to generic oral PrEP – but this seems difficult given the signal from the US price.<\/strong><\/p>\n

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

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  1. FDA news release. FDA approves first injectable treatment for HIV pre-exposure prevention (20 December 2021).
    \n<\/span>https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention<\/a><\/li>\n
  2. US FDA approves long-acting injectable HIV treatment: monthly dosing. HTB, (22 January 2021).
    \n    https:\/\/i-base.info\/htb\/39697<\/a><\/li>\n
  3. Fair Pricing Coalition press release. Fair Pricing Coalition welcomes approval of two-month HIV prevention shot, denounces ViiV\u00a0Healthcare\u2019s exorbitant, unsustainable pricing. (23 December 2021).
    \n    https:\/\/www.fairpricingcoalition.org<\/a><\/li>\n<\/ol>\n

    This report was updated on 23 December 2021 to include comments on drug pricing.<\/em><\/p>\n<\/div>\n<\/div>\n

    <\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 20 December 2021, the US FDA approved long-acting cabotegravir injections for pre-exposure prophylaxis (PrEP) against HIV infection. [1] The indication is for HIV negative adults and adolescents weighing at least 35 kg who are at …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-41890","post","type-post","status-publish","format-standard","hentry","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41890","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=41890"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41890\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}