The FDA approval is based on data from 2 clinical trials: SINGLE, a Phase 3 study evaluating treatment-naive adults taking dolutegravir and abacavir/lamivudine as separate pills; and a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir, and lamivudine when taken as a single pill vs. dolutegravir and abacavir/lamivudine as separate pills.
In the SINGLE study, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamviudine arm vs. the Atripla (efavirenz, emtricitabine, tenofovir; Bristol-Myers Squibb and Gilead) arm. The results were statistically significant and met the pre-specified endpoints for superiority. In the bioequivalence study, 80% of the participants on the dolutegravir-based regimen were virologically suppressed at Week 96 vs. 72% of participants on Atripla.
Triumeq will be available as fixed-dose 600mg/50mg/300mg tablets in 30-count bottles.
For more information call (877) 844-8872 or visit Triumeq.com.