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ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV
Date:10/22/2013

LONDON, Oct. 22, 2013 /PRNewswire/ -- ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug Application (NDA) follows the approval of dolutegravir by the US Food and Drug Administration (FDA) in August 2013 under the brand name Tivicay®, approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs).

"People living with HIV and their doctors seek to use appropriate treatment options for the individual, while also trying to minimise the number of pills required for effective and acceptable antiretroviral treatment," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. "This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill."

In Europe, a Marketing Authorisation Application (MAA) for this single-tablet regimen will be submitted in the near future. The review of the MAA for dolutegravir (DTG), submitted in Europe in December 2012, is in progress with the European Medicines Agency (EMA). A combination tablet containing abacavir (ABC) and lamivudine (3TC) is approved and available in the US under the brand name Epzicom® (abacavir sulfate 600 mg + lamivudine 300 mg) and in the EU under the brand name Kivexa®.

The investigational single-tablet combination of DTG/ABC/3TC has sometimes been referred to as "Trii".  The submission announced today is based on data from one pivotal Phase III study of DTG1, supported by three other Phase III/IIIb studies2-4, which ev
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SOURCE ViiV Healthcare
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