The experimental single-tablet 'Quad' HIV pill by Gilead Sciences was found to be statistically equivalent to that containing Reyataz, according to results from a late-stage study said the company.
According to the company the second pivotal Phase 3 trial (Study 103) of its investigational single-tablet Quad regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being studied in treatment-naive HIV-1 patients, met its primary objective of non-inferiority at week 48.
As per the company, the primary endpoint analysis indicated that 90 percent of patients in the Quad arm achieved viral load of less than 50 copies/mL through week 48, compared to 87 percent in the ritonavir-boosted atazanavir plus Truvada arm.
In addition, Gilead reported that the discontinuation rate due to adverse events was higher in the ritonavir-boosted atazanavir arm (5.1 percent), compared to the Quad (3.1 percent).
The Quad combines four Gilead drugs into a single pill and is a keystone of the company's efforts to preserve its domination in the HIV treatment market and fight off a threatening general menace.
Gilead Chief Operating Officer John Milligan, speaking on a conference call, said the company would request a priority review by the Food and Drug Administration, which could clear the way for an approval as early as mid-year 2012.
When approved, Gilead will be in a position to seek to convince doctors to both prescribe the Quad to newly diagnosed HIV patients and perhaps, more significantly, change patients from existing HIV therapies.