{"id":33841,"date":"2018-01-22T11:51:20","date_gmt":"2018-01-22T11:51:20","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=33841"},"modified":"2018-07-01T21:11:13","modified_gmt":"2018-07-01T21:11:13","slug":"doravirine-fdc-submitted-to-fda-in-us-decision-expected-october-2018","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/33841","title":{"rendered":"Doravirine FDC submitted to FDA in US: decision expected October 2018"},"content":{"rendered":"

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

On 8 January 2018, Merck announced that two new applications for the NNRTI doravirine (formally MK-1439) have been submitted to the US FDA. [1]<\/strong><\/p>\n

One application is as a separate drug and the second is as part of a fixed dose combination (FDC) with two generic tenofovir DF (TDF) and generic lamivudine (3TC).<\/p>\n

Applications are based on 48-week results from two ongoing randomised, double-blind phase 3 studies in treatment naive participants with darunavir and efavirenz used as comparitor drugs.<\/p>\n

The DRIVE-FORWARD study randomised 768 treatment naive participants to either doravirine or darunavir\/r, stratified by baseline viral load (<\/> 5 log) and investigator selected NRTI backbone. For the primary endpoint, viral load was <50 copies\/mL in 84% vs 80% in the doravirine vs darunavir arms respectively (difference: +3.9%, 95%CI: \u20131.6 to +9.4). [2]<\/p>\n

Using a similar design, the DRIVE-AHEAD study randomised 734 treatment-naive participants to either the a doravirine FDC or efavirenz FDC, both coformulated with TDF\/FTC. At week 48, viral load was < 50 copies\/mL was achieved by 84% vs 80% in the doravirine vs efavirenz arms respectively (difference: +3.5%, 95%CI: \u20132.0 to +9.0). [3]<\/p>\n

The FDA decision will be announced by 23 October 2018.<\/p>\n

References<\/p>\n

    \n
  1. Merck press statement. FDA accepts new drug applications for Merck\u2019s doravirine, the company\u2019s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), for treatment of HIV-1 infection. (08 January 2018)
    \nhttp:\/\/investors.merck.com\/news\/press-release-details\/2018\/FDA-Accepts-New-Drug-Applications-for-Mercks-Doravirine-the-Companys-Investigational-Non-Nucleoside-Reverse-Transcriptase-Inhibitor-NNRTI-for-Treatment-of-HIV-1-Infection\/default.aspx<\/a><\/li>\n
  2. Molina J-M et al. Doravirine is non-inferior to darunavir\/r in phase 3 treatment-naive trial at week 48. CROI 2017, 13-16 February 2017, Seattle. Late breaker oral abstract 45LB.
    \n    http:\/\/www.croiconference.org\/sessions\/doravirine-non-inferior-darunavirr-phase-3-treatment-na\u00efve-trial-week-48<\/a><\/li>\n
  3. Squires K et al. Fixed dose combination of doravirine\/lamivudine\/TDF is non-inferior to efavirenz\/emtricitabine\/TDF in treatment-naive adults with HIV-1 infection: week 48 results of the Phase 3 DRIVE-AHEAD study. IAS 2017, 23-26 July, Paris. Oral late-breaker abstract TUAB0104LB.
    \n    http:\/\/programme.ias2017.org\/Abstract\/Abstract\/5585<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 8 January 2018, Merck announced that two new applications for the NNRTI doravirine (formally MK-1439) have been submitted to the US FDA. [1] One application is as a separate drug and the second is as …<\/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-33841","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33841","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=33841"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33841\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=33841"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=33841"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=33841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}