ViiV Healthcare has been granted marketing authorisation by the European Commission for Triumeq — the newest HIV single tablet regimen (STR). This follows last month’s approval by the US Food and Drug Administration.
As with the FDA approval, the EC’s authorisation is based primarily upon data from two clinical trials: the phase III SINGLE study conducted with dolutegravir and abacavir/lamivudine as separate pills; and a bioequivalence study of the fixed-dose combination of dolutegravir, abacavir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.
The fourth STR to gain EC approval, Triumeq offers people living with HIV the first STR without food requirements or restrictions. Triumeq is also the only STR to include an unboosted integrase inhibitor, dolutegravir (Tivicay).
An application for licensing of Triumeq is currently with the TGA.