ViiV Healthcare seeks approval for dolutegravir

ViiV Healthcare Ltd. submitted regulatory applications in the U.S., EU and Canada for dolutegravir to treat HIV infection in patients ages 12 years and older. The submissions include data from the Phase III VIKING-3 and SAILING trials in treatment-experienced patients as well as data from the Phase III SPRING-2 and SINGLE trials in treatment-naïve patients. Last month, ViiV reported that in the VIKING-3 trial, the addition of dolutegravir to patients' current failing integrase inhibitor-containing regimen significantly reduced mean HIV-1 RNA levels from baseline to day eight, a co-primary endpoint (p<0.001) (see BioCentury Extra, Nov. 14). ...