Dolutegravir: Phase III data

The double-blind, international Phase III SINGLE trial (ING114467) in 833 treatment-naïve patients with HIV-1 infection showed that once-daily 50 mg dolutegravir plus Epzicom abacavir/lamivudine was superior to Atripla emtricitabine/tenofovir/efavirenz on the primary endpoint of the proportion of patients with undetectable HIV-1 RNA levels (<50 copies/mL) at week 48 (88% vs. 81%, p=0.003). The partners said the trial was designed to demonstrate non-inferiority on the primary endpoint and statistical superiority was concluded as part of a subsequent pre-specified analysis. Additionally, the partners said that the differences in efficacy between treatment groups were primarily driven by a lower rate of discontinuation due to adverse events in patients receiving dolutegravir plus Epzicom vs. Atripla (2% vs. 10%). ...