Earlier on Monday, Gilead Sciences Inc. announced that a late-stage study for a 4-drug combination pill “Quad,” intended to treat HIV, achieved its primary endpoint.
Gilead said that Quad was as effective as Atripla, the company’s 3-drug combo for HIV. Subsequent to a 48-week treatment, 88% patients receiving Quad demonstrated decreased blood virus levels, thus meeting the primary endpoint of the study. The figure stands at 84% for patients administered Atripla.
Both patient groups demonstrated similar side effects and discontinuation rates.
With the trial spread over 96 weeks, Gilead is expected to submit a full report of its results early in 2012 at a scientific conference. By the end of September, the company hopes to present results of a second late-stage trial, following which it will prepare an FDA application for the Quad pill during the first quarter of 2012.
Quad is a 4-drug combination pill for HIV comprising emtracitabine and tenofovir, which have received FDA approval, as well as elvitegravir and cobicistat, which are yet to be approved. Gilead’s Truvada contains Emtracitabine and tenofovir, and these two drugs also make up for two of the three components in Atripla. While Elvitegravir is designed to prevent the HIV virus from integrating into the DNA, cobicistat is intended to boost the efficacy of other drugs.
Gilead and Bristol-Myers Squibb Co. jointly market the first once-a-day HIV drug, Atripla.
In morning trading, Gilead shares plummeted 5 cents to $37.38.