Dolutegravir indicates superiority compared to efavirenz in treatment-naïve patients: top-line results only

Just prior to IAS conference in Washington, a press release from Shionogi-ViiV outlined top-line results from a phase III indicating that the investigational integrase inhibitor had produced superior results compared to efavirenz.

Although not seen as a helpful way to review new clinical data, once primary endpoint results are available, trading laws in the US and some other countries mandate that they are released publically, in the interest of transparency.

The press release included results from the SINGLE study, specifically that a dolutegravir-basred combination demonstrated superiority compared to Atripla in treatment naïve patients. This was based on viral suppression at 48 weeks of 88% vs. 81% (difference 7.4%; 95%CI: +2.5% to +12.3%, p=0.003).

This difference was driven by a lower rate of discontinuations due to side effects in the dolutegrvir arm (2% vs. 10%).

Further details are needed when the study is presented or published before any further comment is warranted.

Source: Shionogi-ViiV Healthcare press release. Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV. (11 July 2012).