{"id":36263,"date":"2019-07-17T07:40:24","date_gmt":"2019-07-17T07:40:24","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36263"},"modified":"2019-07-17T10:19:50","modified_gmt":"2019-07-17T10:19:50","slug":"dolutegravir-lamivudine-dovato-approved-as-dual-hiv-combination-in-eu","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36263","title":{"rendered":"Dolutegravir\/lamivudine approved as dual HIV combination in EU"},"content":{"rendered":"

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

On 3 July 2019, dolutegravir\/lamivudine was approved as a two-drug fixed dose combination (FDC) in the EU. [1]<\/span><\/strong><\/p>\n

This follows approval in the US in April 2019. [2]<\/span><\/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

Reference<\/span><\/p>\n

    \n
  1. ViiV press statement. ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir\/lamivudine),\u00a0a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection. (03 July 2019).
    \nhttps:\/\/www.gsk.com\/en-gb\/media\/press-releases\/viiv-healthcare-receives-eu-marketing-authorisation-for-dovato-dolutegravirlamivudine-a-new-once-daily-single-pill-two-drug-regimen-for-the-treatment-of-hiv-1-infection\/<\/a>
    \n<\/span><\/li>\n
  2. FDA announcement list serve. 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
  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.<\/span>
    \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)<\/span><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 3 July 2019, dolutegravir\/lamivudine was approved as a two-drug fixed dose combination (FDC) in the EU. [1] This follows approval in the US in April 2019. [2] DTG\/3TC is a once-daily combination that can be …<\/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-36263","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36263","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=36263"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36263\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36263"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}