The Phase 2 study will evaluate GS-7340 as part of a once-daily, co-formulated single-tablet regimen that will also contain the boosting agent cobicistat, the integrase inhibitor elvitegravir, and Emtriva® (emtricitabine) [i.e. Quad with GS-7340 substituted for Viread]. The GS-7340-containing single-tablet regimen will be compared to Gilead’s Quad single-tablet regimen, which contains Viread and Emtriva (as Truvada®), elvitegravir and cobicistat, and is currently under review for marketing approval by U.S. and European regulatory agencies.
Gilead plans to initiate a second Phase 2 trial for GS-7340 later in 2012 that will assess GS-7340 as part of another single-tablet regimen containing cobicistat, Emtriva and Tibotec Pharmaceuticals’ protease inhibitor Prezista (darunavir). Gilead announced an agreement with Tibotec to develop this single-tablet regimen on November 15, 2011[#msg-69031745].
Due to the expiration of the Viread (and probably Truvada) US patents in 2017, GILD has a lot riding on the success of GS-7340. See #msg-62301844 for background.
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