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.