Dolutegravir regulatory update

ViiV submitted regulatory applications in the U.S., EU and Canada for dolutegravir to treat HIV infection in patients ages >=12 years. 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 8, a co-primary endpoint (p<0.001) (see BioCentury, Nov. 19). ...