Elvitegravir (Gilead Sciences) is filed at FDA for HIV-1 Infection in treatment-experienced adults - 05-Jul-2012
Elvitegravir,from Gilead Sciences, an integrase inhibitor for treatment for HIV-1 infection in treatment-experienced adults is filed at the FDA. The submission is supported by 96-week data from a pivotal Phase III 145 study, in which the drug dosed once daily at 150mg or 85mg was non-inferior to the integrase inhibitor raltegravir 400mg dosed twice daily – each administered with a background regimen that included a fully active ritonavir-boosted protease inhibitor and a second antiretroviral.The drug was filed at EMA last month.
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