Dolutegravir meets HIV endpoint

Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) and ViiV Healthcare Ltd. said once-daily dolutegravir plus Epzicom abacavir/lamivudine was superior to Atripla emtricitabine/tenofovir/efavirenz in the Phase III SINGLE trial to treat HIV-1 infection in treatment-naive patients. Dolutegravir was superior on the primary endpoint of the proportion of patients with undetectable HIV-1 RNA levels at week 48 (88% vs. 81%, p=0.003). The double-blind, international trial enrolled 833 patients. 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. Dolutegravir is an HIV integrase inhibitor. ...