Reuters (09.19.11) - Tuesday, September 20, 2011
Gilead Sciences Inc. announced on Monday that its
investigational once-daily "Quad" tablet reduced HIV viral
loads in treatment-naive trial participants as well as a
regimen combining existing treatments. The Foster City,
Calif.-based company plans to request Food and Drug
Administration "priority review" by the end of this year,
rather than the first quarter of next year as previously
announced. Approval could be granted as early as mid-2012.
The Quad pill combines two experimental agents, the integrase
inhibitor elvitegravir and the boosting agent cobicistat, with
Truvada (emtricitabine/tenofovir). In this latest Phase III
trial, Quad was compared with ritonavir-boosted atazanavir
(Reyataz) plus Truvada.
At the end of 48 weeks, 90 percent of patients taking Quad
achieved an HIV RNA viral load of less than 50 copies/mL,
compared with 87 percent of participants on the control
regimen. While 5.1 percent dropped out of the control group
due to adverse events (primarily due to elevated bilirubin
levels), just 3.1 percent of Quad participants did so.
"The 90 percent response rate observed on the Quad arm in this
study is an unprecedented result and speaks to the potency,
safety, and convenience of an integrase-based single-tablet
regimen," said Norbert Bischofberger, PhD, Gilead's chief
"Overall the data are good ... mostly in line with investor
expectations," said Cowen and Co. analyst Philip Nadeau. "I
think there might have been a little bit of expectation for
statistical superiority, but only from a few outliers."