Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Feb 18 2010

Gilead Sciences, Inc. (Nasdaq:GILD) announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada^® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla^® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg). At 24 weeks, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure, intent-to-treat population). Discontinuation rates due to adverse events were comparable in both arms of the study. These data will be presented today at the 17th Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco (Abstract #58LB).

“Simplified treatment regimens of co-formulated, fixed-dose medicines have become the standard of care in HIV therapy because they can help patients adhere to dosing schedules”

“Simplified treatment regimens of co-formulated, fixed-dose medicines have become the standard of care in HIV therapy because they can help patients adhere to dosing schedules,” said Calvin J. Cohen, MD, M.Sc., principal investigator and Director of Research, Community Research Initiative of New England. “These positive efficacy and safety results indicate that the Quad has the potential to become an important new treatment option in HIV therapy.”

The Quad contains four Gilead compounds in a single, once-daily tablet: elvitegravir, an investigational integrase inhibitor for HIV; cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain HIV medicines; and Truvada, which is itself a combination of the two HIV medicines emtricitabine and tenofovir disoproxil fumarate.

Gilead is also studying cobicistat as a stand-alone boosting agent for other antiretroviral medications – in particular, once-daily protease inhibitors such as atazanavir. Currently, ritonavir is the only agent used to boost HIV therapy. Data from a Phase II clinical trial evaluating the safety and efficacy of cobicistat-boosted atazanavir plus Truvada compared to ritonavir-boosted atazanavir plus Truvada will also be presented today at CROI.

“We are dedicated to developing new HIV treatment regimens that feature improved efficacy and tolerability profiles, both of which are increasingly important as patients remain on therapy for longer periods of time,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We are excited about these results and look forward to working with the U.S. Food and Drug Administration to finalize the Phase III clinical program for the Quad and cobicistat.”

SOURCE Gilead Sciences