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ViiV Healthcare files marketing authorisation application in Europe for three-drug HIV pill (integrase dolutegravir) Oct 28 2013
ViiV Healthcare has submitted a marketing authorization application (MAA) in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) to treat HIV-1 patients.
The MAA follows the approval of once-daily integrase inhibitor Tivicay (dolutegravir) in August 2013 by the US FDA for use with other antiretroviral agents (ARVs) for the treatment of HIV-1 in adults and children aged 12 and above.
ViiV Healthcare chief medical officer John Pottage said people living with HIV and their doctors are looking to use suitable treatment options for the individual, while also trying to reduce the number of pills required for effective and acceptable antiretroviral treatment.
"This submission, together with the New Drug Application submitted recently to the US Food and Drug Administration, aims to make a complete dolutegravir-based regimen available for the first time in a single once-daily pill," Pottage said. The review of the MAA for dolutegravir (DTG) was submitted to the European Union in December 2012 and is currently being reviewed by the European Medicines Agency (EMA).
ViiV Healthcare, a joint venture involving GlaxoSmithKline (GSK), Pfizer and Shionogi, already sells a tablet combining ABC and 3TC in the US and Europe under the brand name Epzicom and Kivexa respectively.
The recent application for the three drug pill, which has sometimes been referred to as 'Trii', is backed by data secured from a Phase III trial of DTG and three other Phase III/IIIb studies, which assessed the safety and efficacy of the regimen.
Tivicay is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), used in combination with other antiretroviral agents for the treatment of HIV-1 infection in people above 12-years-old.

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