Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients.
The company provided 96-week data from a pivotal Phase III study in which elvitegravir (150mg or 85mg) dosed once daily 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.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds, which interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
Elvitegravir is also a component of Gilead's once-daily Quad single tablet regimen, currently under US and European regulatory review for treatment-naïve adult patients.
The Quad contains four Gilead compounds in a complete once-daily, single tablet regimen elvitegravir 150mg, cobicistat 150mg, a boosting agent that enables elvitegravir once-daily dosing and Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg).
