ViiV Healthcare, a global specialist HIV company established by GSK and Pfizer, has submitted 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 DTG, supported by three other phase III/IIIb studies, which evaluated the safety and efficacy of this regimen. It additionally includes pivotal data evaluating the bioequivalence of DTG/ABC/3TC when taken as a single-tablet regimen compared to the administration of DTG with ABC/3TC as separate components. A further 48-week phase IIIb/IV study of this single-tablet regimen in treatment-naive HIV-positive women (the ARIA study) is ongoing.

Tivicay is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating Tivicay: poor virologic response was observed in subjects treated with Tivicay 50 mg twice daily with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.

Epzicom, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection. Epzicom is one of multiple products containing abacavir. Before starting Epzicom, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir. In one controlled study, more patients taking abacavir 600 mg once daily had severe hypersensitivity reactions compared to patients taking abacavir 300 mg twice daily. As a part of a triple-drug regimen, Epzicom is recommended for use with ART agents from different pharmacological classes and not with other NRTIs


ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.