GS-7340/elvitegravir/cobicistat/emtricitabine: Phase II started
Gilead began a double-blind, U.S. Phase II trial to compare a once-daily single-tablet regimen of GS-7340 plus elvitegravir/cobicistat/emtricitabine vs. Gilead's Quad elvitegravir/cobicistat/emtricitabine/tenofovir regimen in about 150 treatment-naïve adults.
GS-7340 is in Phase II testing for HIV infection. Elvitegravir, an HIV integrase inhibitor, and cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), are in Phase III testing outside of Japan. Gilead has ex-Japanese rights to elvitegravir from Japan Tobacco Inc. (Tokyo:2914; Osaka:2914, Tokyo, Japan) under a 2005 deal. Gilead markets Emtriva emtricitabine, a nucleoside analog reverse transcriptase inhibitor (NRTI). In December, EMA and FDA accepted an MAA and NDA for review, respectively, for its fixed-dose Quad regimen to treat HIV-1 infection in adults (see BioCentury, Jan. 2). The NDA has an Aug. 27 PDUFA date. ...