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Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

 
• By Sue Sutter

Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.

Renal toxicity concerns failed to keep Gilead Sciences Inc.’s HIV treatment Quad from sailing through an FDA advisory committee review May 11. Although the panel rendered a lopsided vote in favor of approval, it nevertheless suggested a variety of areas for post-marketing study to better define the four-in-one, fixed-dose combination’s efficacy and safety profile.

In a 13-1 vote, the Antiviral Drugs Advisory Committee said the available data support approval of Quad (elvitegravir/cobicistat/emtricitabine/tenofovir) as a...

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