ViiV Healthcare, a joint venture involving GlaxoSmithKline (GSK), Pfizer and Shionogi, has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for treatment of HIV-1 patients.

The NDA followed the approval of once-daily integrase inhibitor Tivicay (dolutegravir) in August for use with other antiretroviral agents (ARVs) for the treatment of HIV-1 in adults and children aged 12 and older.

ViiV Healthcare chief medical officer John Pottage said people with HIV and their doctors are looking to use an appropriate treatment options for the individual, while also trying to reduce the number of pills required for effective and acceptable antiretroviral treatment.

"This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill," Pottage said.

The company is also expected to submit a marketing authorisation application (MAA) for the single-tablet regimen in Europe in the near future.

Dolutegravir (DTG) MAA was submitted to the European Union in December 2012 and is currently under review by the European Medicines Agency (EMA).

The company already sells a tablet combining abacavir (ABC) and lamivudine (3TC) in the US and Europe under the brand name Epzicom and Kivexa respectively.

The NDA 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.

In addition, the submission is supported by pivotal data that assessed the bioequivalence of the three drug pill when taken as a single-tablet regimen compared with the administration of DTG with ABC/3TC as separate components.

A further 48-week Phase IIIb/IV trial of the single-tablet regimen in treatment-naive HIV-positive women is ongoing, the company said.

Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), used in combination with other antiretroviral agents to treat HIV-1 infection in those above 12-years-old.