{"id":41427,"date":"2021-10-31T07:29:18","date_gmt":"2021-10-31T07:29:18","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41427"},"modified":"2021-11-01T12:12:19","modified_gmt":"2021-11-01T12:12:19","slug":"41427","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41427","title":{"rendered":"Gilead withdraws application for F\/TAF as PrEP in the EU"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 20 October 2021, Gilead Sciences announced that the company will no longer look to market F\/TAF (Descovy) as PrEP in the EU. <\/span><\/strong><\/p>\n<\/div>\n

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This is a significant policy change given the years of investment and positive results from phase 3 studies showing that F\/TAF had potential advantages compared to F\/TDF. However, these were generally slight: statistically significant reductions in bone and kidney toxicity were unlikely to be clinically significant for most people and numerically fewer HIV infections were not statistically significant.<\/span><\/p>\n<\/div>\n

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The reason for the withdrawal is likely be linked to the large price difference charged for F\/TAF compared to F\/TDF would not be acceptable to European health systems.<\/span><\/p>\n<\/div>\n

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EU countries have wider access to generic versions of F\/TDF which is at least 90% cheaper than the hoped for marketing price for F\/TAF.\u00a0<\/span><\/p>\n<\/div>\n

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The press release states that Gilead will continue to provide F\/TAF to study participants in the EU who were enrolled in the phase 3 DISCOVER study.<\/span><\/p>\n<\/div>\n

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This may be to cover the ethical and regulatory requirements (including in the Helsinki declaration) that pharmaceutical companies need to provide post-trial access to treatment for patients participating in clinical trials. [2]<\/span><\/p>\n

comment<\/h3>\n<\/div>\n
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This decision is a shame. If both options were the same price, F\/TAF might be more widely used. <\/span><\/strong><\/p>\n<\/div>\n

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It is a smaller tablet and it has better pharmacokinetics that likely make is more protective if doses are missed.<\/span><\/strong><\/p>\n<\/div>\n

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UK residents are able to buy and important generic versions of F\/TAF online for personal use, although this is only allowed in a few other EU countries.<\/span><\/strong><\/p>\n<\/div>\n

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

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  1. Gilead press statement. Gilead announces decision not to pursue marketing authorization for Descovy for pre-exposure prophylaxis in the European Union. (20 October 2021).
    \n<\/span>https:\/\/www.gilead.com\/news-and-press\/company-statements\/gilead-announces-decision-not-to-pursue-marketing-authorization-for-descovy-for-pre-exposure-prophylaxis-in-the-european-union<\/a><\/li>\n
  2. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects.
    \n    https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects<\/a><\/li>\n<\/ol>\n

    This report was first published on 20 October 2021.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 20 October 2021, Gilead Sciences announced that the company will no longer look to market F\/TAF (Descovy) as PrEP in the EU. This is a significant policy change given the years of investment and positive …<\/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-41427","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\/41427","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=41427"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41427\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41427"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41427"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}