ViiV and Shionogi say dolutegravir meets primary endpoint in HIV

ViiV Healthcare, the HIV/AIDS joint venture of UK drugs giant GlaxoSmithKline (LSE: GSK) and US behemoth Pfizer (NYSE: PFE), and Japanese major Shionogi (TYO:4507) have revealed positive initial results from the SPRING-2 (ING113086) Phase III study of their 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) versus 85% of participants on raltegravir, Merck & Co’s Isentress, (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 pre-specified -10% non-inferiority limit).

If dolutegravir gains regulatory approval, which is anticipated for 2013, it would enter an HIV antiretrovirals market worth $13 billion in 2010 in the world’s major pharmaceutical markets and forecast to increase to more than $16 billion in 2020.