September 12, 2011
Results are expected this month in the second pivotal clinical trial of Gilead Sciences Inc.'s four-in-one HIV treatment. Known as "Quad," the pill combines the experimental integrase inhibitor elvitegravir and the boosting agent cobicistat with Truvada, which contains Gilead's older HIV drugs Emtriva and Viread. If approved, Quad would be the first single-tablet HIV regimen to include an integrase inhibitor, which seeks to block HIV's ability to replicate. Currently, the only integrase inhibitor to gain approval is Merck & Co. Inc.'s Isentress (raltegravir), which must be taken twice daily. Gilead said in August that its first pivotal trial of Quad met the goal of showing it worked as well as Atripla, Gilead's three-drug HIV pill; analysts, however, say it may need to show superiority to convince investors of its potential. A lower-cost generic version of Atripla could be on the market in 2018. Full safety data from the first trial will be presented at a medical conference in March; Gilead plans to submit Quad for U.S. regulatory approval in the first quarter of 2012.