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FDA: Safety Of Proposed Gilead HIV Drug "Generally Acceptable"

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration said the safety of an experimental Gilead Sciences Inc. (GILD) HIV medicine that combines four medicines into one pill was "generally acceptable." The drug, known as the Quad, combines Gilead's double-drug Truvada, the drug elvitegravir and an agent that boosts blood levels of certain HIV drugs, cobicistat. The company is seeking FDA approval for the medicine, and the product will be reviewed Friday by the agency's antiviral drugs advisory panel. The panel of non-FDA medical experts will make a recommendation to the agency about whether it thinks the Quad should be approved. The FDA released background material Wednesday in preparation for the meeting. The agency said clinical studies of the Quad showed it met study goals looking at effectiveness by reducing viral load in patients and said adverse-events were similar among patients treated with the Quad compared to those being treated with other HIV drugs. However, the FDA said it appeared that more patients in the Quad study groups stopped the drug because of kidney-related side-effects compared to patients not receiving the drug. Gilead is hoping that the one-pill, once-daily Quad regimen will provide more convenience to HIV patients, many of whom now take multiple pills for treatment. Some analysts think it could become a blockbuster seller. Gilead submitted two clinical studies involving Quad. One 700-patient study compared it with Atripla, which combines three HIV medicines in a single, once-daily pill, as an initial therapy for HIV infection. Atripla is a combination of Gilead's Truvada with Bristol-Myers Squibb Co.'s (BMY) Sustiva. The study met its goal of showing both drugs were similar at treating HIV by suppressing the so-called viral load. The study found that 88% of Quad recipients had viral suppression 48 weeks after starting treatment, versus 84% of Atripla users. Another study involving about 700 patients compared the Quad to patients taking Truvada in addition to another HIV drug, atazanavir/ritonavir and showed the Quad reduced viral load in 90% of patients after 48 weeks compared to 87% of patients being treated with the other drugs. -By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

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