{"id":44319,"date":"2022-12-01T07:30:48","date_gmt":"2022-12-01T07:30:48","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=44319"},"modified":"2022-12-21T10:35:55","modified_gmt":"2022-12-21T10:35:55","slug":"cabotegravir-la-submitted-to-ema-for-use-as-prep-in-europe","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/44319","title":{"rendered":"Cabotegravir-LA submitted to EMA for use as PrEP in Europe"},"content":{"rendered":"
Simon Collins, HIV i-Base<\/span><\/strong><\/div>\n
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On 28 October 2022, ViiV Healthcare announced that the European Medicine’s Agency had ‘validated’ its application for cabotegravir-LA (CAB-LA) to be used as PrEP.\u00a0<\/span><\/strong><\/p>\n<\/div>\n

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CAB-LA is a long-acting formulation that is given by intramuscular injection every two months to prevent HIV transmission, irrespective of condom use.<\/span><\/p>\n<\/div>\n

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The application is largely based on results from two large international phase 3 studies called HPTN 083 and 084. Both studies randomised participants to either CAB-LA or to daily oral PrEP using TDF\/FTC and reported that significantly fewer people receiving CAB-LA became HIV positive. These results have previously been reported in HTB. [2, 3]<\/span><\/p>\n<\/div>\n

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C<\/span>AB-LA is already<\/span> approved<\/span> for PrEP <\/span>in the US,<\/span> Australia and<\/span>, most recently, <\/span>Zimbabwe<\/span>. [4]<\/span><\/p>\n<\/div>\n

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It is marketed under the brand name <\/span>Apretude.<\/span><\/p>\n<\/div>\n

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comment<\/span><\/h3>\n<\/div>\n
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This is important news. S<\/span><\/strong>ubmitting CAB-LA recognises that access in the EU is essential \u2013 and that ViiV want to find a European market for new PrEP formulations.<\/span><\/strong><\/p>\n<\/div>\n

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Although ViiV has previously stated a commitment to submitting for approval in the EU, regulatory documents were submitted first in South Africa, Malawi, Botswana, Brazil, Kenya, Uganda, Vietnam, Malaysia, Myanmar, Philippines and China. [5]<\/span><\/strong><\/p>\n<\/div>\n

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Access however is also dependent on having an affordable price, which in Europe will be compared to generic oral PrEP. <\/span><\/strong><\/p>\n<\/div>\n

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It is unclear how this will be reconciled with the significantly higher price for CAB-LA when used as treatment, not just in the EU but in all regions. \u00a0In the US, CAB-LA for PrEP is currently listed at $22,000 pa.<\/span><\/strong><\/p>\n

The lack of an effective market for high-priced PrEP is the reason that Gilead cancelled their PrEP application for F\/TAF (Descovy) in the EU. [6]<\/strong><\/p>\n<\/div>\n

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

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    \n
  1. ViiV press release. <\/span>European Medicines Agency validates ViiV Healthcare\u2019s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention<\/span>. (28 October 2022).
    \n<\/span>https:\/\/viivhealthcare.com\/hiv-news-and-media\/news\/press-releases\/2022\/october\/european-medicines-agency-validates-viiv-healthcare<\/a><\/li>\n
  2. Cabotegravir long-acting injections prevent HIV as PrEP. HTB (June 2020).
    \n    https:\/\/i-base.info\/htb\/37961<\/a><\/li>\n
  3. Two-monthly cabotegravir injections prevent HIV infection in African women: HPTN 084 study recommends early unblinding. HTB (November 2020).
    \n    https:\/\/i-base.info\/htb\/39327<\/a><\/li>\n
  4. ViiV press release. P<\/span>rogress in our commitment to enabling access to cabotegravir long-acting for hiv prevention, as first sub-Saharan African country approves Apretude. (Undated, but likely 20 October 2022).
    \n<\/span>    https:\/\/viivhealthcare.com\/hiv-news-and-media\/news\/company-statements\/progress-in-our-commitment-to-enabling-access<\/a><\/li>\n
  5. ViiV Healthcare. Worldwide registration: cabotegravir PrEP. [Accessed 28 October 2022].
    \n    https:\/\/viivhealthcare.com\/content\/dam\/cf-viiv\/viivhealthcare\/en_GB\/files\/cab-prep-wwrs-10oct2022-for-external-use.pdf<\/a> (PDF)<\/li>\n
  6. Gilead withdraws application for F\/TAF as PrEP in the EU. HTB (October 2021).
    \n    https:\/\/i-base.info\/htb\/41427<\/a><\/li>\n<\/ol>\n

    First published 28 October 2022.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 28 October 2022, ViiV Healthcare announced that the European Medicine’s Agency had ‘validated’ its application for cabotegravir-LA (CAB-LA) to be used as PrEP.\u00a0 CAB-LA is a long-acting formulation that is given by intramuscular injection every …<\/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-44319","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\/44319","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=44319"}],"version-history":[{"count":3,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44319\/revisions"}],"predecessor-version":[{"id":44635,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44319\/revisions\/44635"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=44319"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=44319"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=44319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}