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news.Gilead Sciences said the randomized, double-blind Phase III trial of its experimental drug Elvitegravir, for the treatment of HIV-1 infection in treatment-experienced patients, met its primary objective.
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The Phase III 48-week clinical trial evaluating the non-inferiority of Elvitegravir versus Raltegravir each administered with a background regimen in HIV-infected treatment-experienced adults with HIV RNA (viral load) of greater than or equal to 1,000 copies/ml.
The primary endpoint analysis indicated that 59% of patients in the Elvitegravir arm compared to 57.8% in the Raltegravir arm achieved and maintained a viral load of less than 50 copies/ml through week 48.
Elvitegravir is also being studied as part of Gilead’s investigational fixed-dose, single-tablet ‘Quad’ regimen.
Gilead Sciences Research and Development executive vice president and chief scientific officer Norbert Bischofberger said they are very pleased to have achieved the primary endpoint in this clinical trial, as data from this study will support regulatory filings for Elvitegravir as well as Gilead’s investigational Quad pill.