Quad elvitegravir/cobicistat/emtricitabine/tenofovir: Additional Phase III data

Additional data from the 96-week, double-blind, international Phase III Study 103 trial in 708 treatment-naive patients showed that once-daily Quad led to significantly smaller increases from baseline in triglycerides vs. ritonavir-boosted atazanavir plus Truvada emtricitabine/tenofovir (8 vs. 23 mg/dL, p=0.006). Mean increases in CD4+ cell counts were similar between treatment groups (207 vs. 211 cell/mm 3). Data were presented at the Retroviruses and Opportunistic Infections meeting in Seattle. Last year, Gilead reported that Quad met the primary endpoint of non-inferiority to ritonavir-boosted atazanavir plus Truvada in the proportion of patients who achieved HIV RNA levels <50 copies/mL at week 48 (90% vs. 87%, 95% CI for the difference: -1.9%, 7.8%). The predefined criterion for non-inferiority was a lower bound of a 2-sided 95% CI of -12% (see BioCentury, Sept. 26, 2011). In December, Gilead said EMA and FDA accepted an MAA and NDA for review, respectively, for Quad to treat HIV-1 infection in adults. The NDA has an Aug. 27 PDUFA date. ...