Viiv Healthcare submits Trii to EMA for HIV

ViiV Healthcare has submitted a regulatory application in Europe for its investigational single-tablet regimen (STR) known as Trii, combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for the treatment of people living with HIV. The submission 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 components5. A further 48-week Phase IIIb/IV study of this single-tablet regimen in treatment-naive HIV-positive women (the ARIA study) is ongoing.

The review of the MAA for dolutegravir (DTG), submitted in Europe in December 2012, is in progress with the European Medicines Agency (EMA). A fixed-dose combination of ABC/3TC for use in antiretroviral combination therapy is marketed by ViiV Healthcare in Europe under the brand name Kivexa as a once-daily tablet. This Marketing Authorisation Application (MAA) follows the announcement earlier this week of a similar regulatory submission in the US.