{"id":36734,"date":"2019-10-18T08:15:51","date_gmt":"2019-10-18T08:15:51","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36734"},"modified":"2019-10-31T12:07:55","modified_gmt":"2019-10-31T12:07:55","slug":"us-approves-f-taf-for-prep-descovy-indication-excludes-risk-from-receptive-vaginal-sex","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36734","title":{"rendered":"US approves F\/TAF for PrEP (Descovy): indication excludes risk from receptive vaginal sex"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 3 October 2019, the US FDA approved the dual formulation F\/TAF with a new indication for HIV pre-exposure prophylaxis (PrEP). [1]<\/strong><\/p>\n

This is the second oral drug to be approved as PrEP.<\/p>\n

Approval was based on results from the phase 3 DISCOVER study reported earlier this year at CROI that used F\/TDF as an active control. [2]<\/p>\n

However, approval was controversial for only allowing a limited indication based on the study population in DISCOVER: gay or bisexual men and transgender women.<\/p>\n

The application had been for adult use (including woman) and the split panel decided that efficacy data was required in all populations for a broad indication.<\/p>\n

The decision not to include women in the initial phase 3 studies was questioned at the time and the manufacturers now have a post marketing commitment to run additional studies in cisgender women and adolescent girls. [1]<\/p>\n

More recent data from the DISCOVER study have shown that the pharmacokinetic benefits of F\/TAF might have significant advantages for women. [3]<\/p>\n

F\/TAF is manufactured by Gilead Sciences with the trade name Descovy.<\/p>\n

comment<\/h4>\n
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The FDA Antimicrobial Drugs Advisory Committee voted 16 to 2 for approval of F\/TAF in men who have sex with men and transgender women but 8 to 10 against approval in cisgender women.\u00a0[4] <\/strong><\/p>\n

This was based on the potential for different pharmacokinetics in rectal vs vaginal tissue to affect clinical efficacy and lack of efficacy data in cisgender women.\u00a0<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n

References<\/p>\n

    \n
  1. Gilead press release. US Food and Drug Administration approves Descovy for HIV pre-exposure prophylaxis (PrEP). <\/span>(03 October 2019).
    \n<\/span>https:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2019\/10\/us-food-and-drug-administration-approves-descovy-for-hiv-preexposure-prophylaxis-prep<\/a><\/li>\n
  2. Collins S. New option for PrEP \u2013 TAF\/FTC is non-inferior to TDF\/FTC: results of phase 3 DISCOVER study. HTB 12 March 2019.
    \n    https:\/\/i-base.info\/htb\/35809<\/a><\/li>\n
  3. Collins S. PK advantages of TAF\/FTC over TDF\/FTC for HIV PrEP might compensate for low adherence: sub-analysis of DISCOVER study. HTB (23 August 2019).
    \n    https:\/\/i-base.info\/htb\/36592<\/a><\/li>\n
  4. NATAP. FDA hearing ongoing Wed Aug 7 2019 on Descovy for PrEP vote. (7 August 2019).
    \n    http:\/\/www.natap.org\/2019\/HIV\/080819_01.htm<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 3 October 2019, the US FDA approved the dual formulation F\/TAF with a new indication for HIV pre-exposure prophylaxis (PrEP). [1] This is the second oral drug to be approved as PrEP. Approval was based …<\/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-36734","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\/36734","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=36734"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36734\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}