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.>
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