NDA Submitted for "Quad" for HIV-1 Infection in Adults
Gilead Sciences announced it has submitted a New Drug Application (NDA) for the “Quad”, a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.
The NDA is supported by 48-week data from two pivotal Phase 3 studies in which the Quad met its primary objective of non-inferiority as compared to Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir (Study 103). The NDA is also supported by Chemistry, Manufacturing and Controls information on the individual components of the Quad and the co-formulated single-tablet regimen.
The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen: elvitegravir, an integrase inhibitor; cobicistat, a “boosting” agent that enables elvitegravir once-daily dosing; and Truvada.
For more information call (800) GILEAD-5 or visit www.gilead.com.