Phase III SAILING study of dolutegravir(ViiV) success in HIV-1

ViiV Healthcare has announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor.

At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c ml vs. 70 of participants on the twice-daily raltegravir regimen. this difference in response was statistically significant with a 95 confidence interval for the difference of 3.4 to 15.9 p="0.003)." the sailing study was designed to demonstrate non-inferiority of a regimen containing dolutegravir versus raltegravir both with up to two background agents and the analysis met this criterion statistical superiority was concluded as part of a pre-specified testing procedure. these data were presented at the 20th conference on retroviruses and opportunistic infections croi in atlanta georgia.>