Once-Daily Dolutegravir is Non-Inferior to Twice-Daily Raltegravir in Treatment-Naive Adults with HIV-1

Once-Daily Dolutegravir is Non-Inferior to Twice-Daily Raltegravir in Treatment-Naive Adults with HIV-1 PR Newswire WASHINGTON, July 26, 2012 -- Shionogi-ViiV Healthcare LLC present full 48-week data results from SPRING-2 Phase III study at International AIDS Conference -- Findings support progression towards registration WASHINGTON, July 26, 2012 /PRNewswire/ -- Shionogi-ViiV Healthcare LLC today announced 48-week data from the SPRING-2 Phase III study, which is evaluating the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1 infection. In this double-blind, double-dummy study, the proportion of study participants who were virologically suppressed (HIV-1 RNA <50 c/mL) was 88% for once-daily dolutegravir (DTG) and 85% for twice-daily raltegravir (RAL), with a 95% confidence interval for the difference, (-2.2% to +7.1%) meeting the 10% non-inferiority limit. Response rates were similar regardless of which dual nucleoside reverse transcriptase inhibitor (NRTI) therapy was used. For study participants with high baseline viral load (HIV-1 RNA >100,000 c/mL), the response rates were 82% for DTG vs. 75% for RAL. These data were presented at the XIX International AIDS Conference in Washington, DC. Prespecified secondary analyses also supported non-inferiority of dolutegravir to raltegravir; the proportion of subjects without treatment-related discontinuations was 93% on dolutegravir and 92% on raltegravir.