Date: 2012-04-02
Type of information: Results
phase: 3
Announcement: results
Company: ViiV Healthcare (UK-USA) Shionogi (Japan)
Product: dolutegravir
Action
mechanism:
Disease: naive adults with HIV-1 infection
Therapeutic area: Infectious diseases
Country:
Trial
details:
Latest news: ViiV Healthcare and Shionogi & Co., have announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1. The study met its primary objective, demonstrating non-inferiority of dolutegravir to raltegravir. Through 48 weeks, 88% of study participants on dolutegravir were virologically suppressed (<50 copies/mL) vs. 85% of participants on raltegravir [with a 95% confidence interval (CI) for the difference, -2.2% to + 7.1%; the lower end of the CI (-2.2%) was above the prespecified -10% non-inferiority limit]. The tolerability of dolutegravir was similar to that of raltegravir, with rates of adverse events leading to withdrawal at 2% in both arms. Drug-related nausea was reported by 10% of patients in each arm; no other adverse events related to study medication were reported by more than 5% of participants in either arm. Full results of this study, including the full results of the secondary endpoints, will be presented at an upcoming scientific meeting. SPRING-2 is the first of four Phase III studies that are due to be reported in 2012. Data from the clinical trials SINGLE (ING114467), VIKING-3 (ING112574) and SAILING (ING111762), will be received throughout the year and will allow further determination of the profile of dolutegravir. These studies are designed to support a future regulatory file for dolutegravir.