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Gilead's HIV drug meets phase III endpoint

A phase III clinical trial has shown Gilead's investigational antiretroviral agent elvitegravir is as effective as Merck's Isentress after 48 weeks

A phase III clinical trial has shown Gilead's investigational antiretroviral agent elvitegravir is as effective as Merck's Isentress after 48 weeks.

During the trial, elvitegravir was dosed once daily, compared to raltegravir, dosed twice daily. Both drugs were administered with a background regimen that includes a ritonavir-boosted protease inhibitor (PI) and a second antiretroviral agent. 

Gilead is studying the use of elvitegravir as part of a separate investigational fixed-dose, single-tablet "Quad" regimen. The Quad contains four Gilead compounds in a fixed-dose, single-tablet and is currently in phase III testing.

"We 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," said Dr Norbert Bischofberger, executive vice president, R&D and chief scientific officer, Gilead Sciences. 

"By analysing these data now we will be in a better position to advance filings as quickly as possible once data from subsequent phase III clinical trials in our Quad development programme become available later this year."

The elvitegravir phase III, randomised, double-blind trial continues and will measure secondary endpoints including various additional measures of the efficacy, safety and tolerability of the two treatment regimens.

23rd March 2011

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