{"id":35990,"date":"2019-04-30T08:30:38","date_gmt":"2019-04-30T08:30:38","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=35990"},"modified":"2019-04-30T18:30:06","modified_gmt":"2019-04-30T18:30:06","slug":"dolutegravir-3tc-dual-fdc-approved-in-the-us","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/35990","title":{"rendered":"Dolutegravir\/3TC dual FDC (Dovato) approved in the US and given positive opinion in the EU"},"content":{"rendered":"

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

On 8 April 2019, the US FDA approved a new single-pill two-drug fixed dose combination (FDC) of dolutegravir (DTG) plus lamivudine (3TC). [1]<\/span><\/b><\/p>\n

A few weeks later, positive opinion for dolutegravir\/lamivudine was also given by the European Medicines Agency, indicating likely approval in the EU. [2]<\/strong><\/p>\n

DTG\/3TC is a once-daily combination that can be taken with or without food.<\/span><\/p>\n

The indication is for treatment-naive adults who do not have drug resistance to either of these two drugs and approval is based on results of the phase 3 GEMINI 1 and 2 studies that were presented at the IAS conference last year. [3, 4]<\/span><\/p>\n

The approval includes a boxed warning for management of patients coinfected with hepatitis B (HBV). All patients should be tested for HBV before starting DTG\/3TC and additional treatment for HBV should be used.<\/span><\/p>\n

There is also a caution for women to avoid dolutegravir during conception and in early pregnancy due to a risk of neural tube defects.<\/span><\/p>\n

Dolutegravir\/3TC is manufactured by ViiV Healthcare and is marketed with the tradename Dovato.<\/span><\/p>\n

For full details see the full product characteristics. [5]<\/span><\/p>\n

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

    \n
  1. FDA announcement listserve. FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment. (8 April 2019).
    \n<\/span>https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm635526.htm<\/span><\/a><\/li>\n
  2. ViiV press statement. ViiV Healthcare announces CHMP Positive Opinion for Dovato\u00ae (dolutegravir\/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection. (26 April 2019).
    \n    https:\/\/www.viivhealthcare.com\/en-gb\/media\/<\/a><\/li>\n
  3. Cahn P et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir\/emtricitabine (TDF\/FTC) fixed-dose combination in antiretroviral treatment-na\u00efve adults with HIV-1 infection \u2013 48-week results from the GEMINI studies. AIDS 2018, 23-27 July 2018, Amsterdam. Late breaker oral abstract TUAB0106LB.
    \n    http:\/\/programme.aids2018.org\/Abstract\/Abstract\/13210<\/a>\u00a0(abstract)
    \n    https:\/\/youtu.be\/pgmb1Fi63Fo?t=3642<\/a>\u00a0(webcast)<\/span><\/li>\n
  4. Collins S. DTG\/3TC dual therapy is non-inferior to triple-ART in GEMINI study. HTB August 2018.
    \n<\/span>    https:\/\/i-base.info\/htb\/34647<\/span><\/a><\/li>\n
  5. ViiV Healthcare. US prescribing information for Dovato. (8 April 2019).
    \n<\/span>    https:\/\/www.gsksource.com\/pharma\/content\/dam\/GlaxoSmithKline\/US\/en\/Prescribing_Information\/Dovato\/pdf\/DOVATO-PI-PIL.PDF<\/a> (pdf)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 8 April 2019, the US FDA approved a new single-pill two-drug fixed dose combination (FDC) of dolutegravir (DTG) plus lamivudine (3TC). [1] A few weeks later, positive opinion for dolutegravir\/lamivudine was also given by the …<\/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-35990","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/35990","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=35990"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/35990\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=35990"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=35990"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=35990"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}