Gilead Sciences doses first patient in Quad Phase III clinical program

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate. The Phase III clinical program for the Quad includes two studies (Studies 102 and 103) that will evaluate the Quad regimen versus a standard of care among HIV-1 infected antiretroviral treatment-naïve adults.

“We are pleased to announce that the Quad Phase III clinical program is underway”

"We are pleased to announce that the Quad Phase III clinical program is underway," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Efficacy and safety results from the Phase II study suggest that the Quad may represent an important new option for patients with HIV. We look forward to further defining the clinical profile of the Quad in a larger number of patients in the Phase III trials."

Gilead is also examining cobicistat as a stand-alone boosting agent for other antiretrovirals, in particular protease inhibitors. Later this quarter, Gilead plans to initiate a Phase III clinical trial evaluating the efficacy, safety and tolerability of cobicistat-boosted atazanavir compared to ritonavir-boosted atazanavir, each in combination with Truvada^® (emtricitabine and tenofovir disoproxil fumarate).

Study Design

Study 102 is a randomized, double-blind clinical trial that will compare the efficacy, safety and tolerability of the Quad versus Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) over a 96-week period at 130 study sites in the United States and Puerto Rico. Eligible participants will be HIV-infected treatment-naïve adults with HIV RNA levels greater than or equal to 5,000 copies/mL. Approximately 700 trial participants will be randomized (1:1) to receive a once-daily tablet containing elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg>

Study 103 is a randomized, double-blind clinical trial that will compare the efficacy, safety and tolerability of the Quad versus ritonavir-boosted atazanavir and Truvada over a 96-week period at more than 200 study sites in North America, South America, Europe and Asia Pacific. Eligible participants will be HIV-infected treatment-naïve adults with HIV RNA levels greater than or equal to 5,000 copies/mL. Approximately 700 trial participants will be randomized (1:1) to receive a once-daily tablet containing elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg>

The primary endpoint of both trials will be the proportion of patients achieving HIV RNA levels of less than 50 copies/mL at 48 weeks of treatment. Secondary objectives will evaluate the efficacy, safety and tolerability of the treatment regimens through 96 weeks of treatment.

After week 96, subjects will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all subjects will be given the option to participate in an open-label rollover extension and receive the Quad single-tablet regimen.