Triumeq FDA approved

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26 Aug 2014

Triumeq — the newest HIV single tablet regimen (STR) — has been approved by the US Food and Drug Administration. A combination of the integrase inhibitor dolutegravir, with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine, ViiV Healthcare’s Triumeq is the fourth STR to have gained FDA approval.

The availability of Triumeq offers people living with HIV the first STR without food requirements or restrictions. Triumeq is also the only STR not to include tenofovir. (Tenofovir’s links to kidney disease and low bone mineral density are of particular concern among the ageing HIV population.)

The FDA approval is based primarily  upon data from two clinical trials, one of which — the SINGLE study — found more participants' viral loads to be undetectable (HIV-1 RNA <50 copies/mL) on Triumeq when compared to Atripla, the most commonly used STR. At 96 weeks, 80% of participants on Triumeq were virologically suppressed compared to 72% of participants on Atripla. Triumeq was also found to be better tolerated.

An application for the licensing of Triumeq is currently with the TGA.