{"id":33422,"date":"2018-02-09T11:50:07","date_gmt":"2018-02-09T11:50:07","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=33422"},"modified":"2018-07-21T11:43:31","modified_gmt":"2018-07-21T11:43:31","slug":"bictegravir-approved-in-the-us-in-new-integrase-inhibitor-based-fdc-bictarvy","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/33422","title":{"rendered":"Bictegravir approved in the US in new integrase-inhibitor based FDC (Biktarvy)"},"content":{"rendered":"
\"\"

Bictarvy FDC tablet (15 x 8 mm)<\/p><\/div>\n

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

On 7 February 2018, the US FDA approved a new fixed dose combination (FDC) containing bictegravir, emtricitabine and tenofovir alafenamide (TAF). [1, 2]<\/strong><\/p>\n

Bictegravir is an integrase inhibitor with a 50 mg dose that does not need to be boosted or taken with food. It is coformulated with 200 mg emtricitabine and a 25 mg dose of TAF.<\/p>\n

Bictegravir has a plasma half-life of 18 hours, which suggests some flexibility for adherence and a resistance profile that might retain sensitivity to resistance mutations associated with raltegravir and elvitegravir but that is similar to dolutegravir. [3]<\/p>\n

Approval is based on results from four ongoing randomised phase 3 studies.<\/p>\n

The FDC is manufactured by Gilead Sciences and will be marketed with the brand name Bictarvy.<\/p>\n

For more details please see the full prescribing information. [4]<\/p>\n

comment<\/h3>\n

Faster US approval was due to a\u00a0Priority Review designation, that enables companies to buy and submit vouchers for an FDA decision with six rather than ten months.<\/strong><\/p>\n

This FDC has already been submitted to the EMA for European approval, with a decision expected later in 2018.<\/strong><\/p>\n

Pricing information was not included in the press release but will play a key role in uptake of the bictegravir FDC, given that dolutegravir is coformulated with two off-patent NRTIs and ViiV Healthcare have ongoing studies using dolutegravir with only lamivudine.<\/strong><\/p>\n

Almost immediately after the bictegravir FDC approval, ViiV Healthcare announced plans for a study that is not yet even listed on the clinical trials registry. This will switch people who are stable on TAF-containing combinations to dolutegravir\/lamivudine dual therapy. [5]<\/strong><\/p>\n

Also following the approval, ViiV<\/strong>\u00a0filed a lawsuit alleging that Gilead was infringing dolutegravir patents. ViiV is seeking \u201cfinancial redress\u201d. [6] <\/strong><\/p>\n

References<\/p>\n

    \n
  1. FDA HIV listserv. FDA approves BIKTARVY tablets (Fixed Dose Combination). (07 February 2018).<\/li>\n
  2. U.S. Food and Drug Administration approves Gilead\u2019s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection. (07 February 2018).
    \nhttp:\/\/www.gilead.com\/news\/press-releases<\/a><\/li>\n
  3. Tsiang M et al. Antiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profile. Antimic Agents and Chem. (September 2016). doi: 10.1128\/AAC.01474-16.
    \n    http:\/\/aac.asm.org\/content\/early\/2016\/09\/13\/AAC.01474-16.abstract<\/a><\/li>\n
  4. Biktarvy US prescribing information and patient leaflet.
    \n    https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210251s000lbl.pdf <\/a>(PDF)<\/li>\n
  5. ViiV press release.\u00a0ViiV Healthcare launches eighth phase III study in two-drug regimen programme for HIV-1 treatment. (08 February 2018).
    \n    https:\/\/www.gsk.com\/en-gb\/media\/press-releases<\/a><\/li>\n
  6. Beasley D. US FDA approves Gilead triple HIV drug, rival files lawsuit. Reuters. 7 February 2017.
    \n    https:\/\/www.reuters.com\/article\/us-gilead-sciences-fda\/u-s-fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 7 February 2018, the US FDA approved a new fixed dose combination (FDC) containing bictegravir, emtricitabine and tenofovir alafenamide (TAF). [1, 2] Bictegravir is an integrase inhibitor with a 50 mg dose that does not …<\/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-33422","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33422","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=33422"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33422\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=33422"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=33422"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=33422"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}