The primary endpoint analysis indicated that 59.0 percent of patients in the elvitegravir arm compared to 57.8 percent in the raltegravir arm (95% CI for the difference: -6.0% to +8.2%) achieved and maintained a viral load of less than 50 copies/mL through week 48. The predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -10%.
By prior agreement with the FDA, this is the only phase-3 study GILD needs to obtain approval for Elvitegravir—provided, of course, that there are no safety problems.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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