LONDON (dpa-AFX) - GlaxoSmithKline Plc (GSK, GSK.L) said Shionogi-ViiV Healthcare LLC, a joint venture between ViiV Healthcare Ltd. and Shionogi & Co., Ltd., announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naïve adults with HIV-1.
The study showed superiority of the dolutegravir-based regimen versus single tablet regimen Atripla. At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed compared to 81% of participants on the single tablet regimen Atripla.
Differences in efficacy were mainly driven by a higher rate of discontinuation due to adverse events on the Atripla arm. The SINGLE study was designed to demonstrate non-inferiority of the dolutegravir-based regimen versus Atripla, and the primary analysis met this criterion. Statistical superiority was concluded as part of a subsequent, pre-specified testing procedure.
Dr. Tsutae 'Den' Nagata, chief medical officer, Shionogi & Co., Ltd., said, 'Taken together with the results of the SPRING-2 trial, the SINGLE findings suggest that, if approved by regulators, a treatment regimen containing dolutegravir may offer people living with HIV an important additional first line option in the future.'
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