NDA Submitted for Single Tablet HIV-1 Infection Regimen
Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults.
The NDA submission included data that supported the use of the regimen among adults and adolescents who are treatment-naïve HIV individuals, virologically suppressed patients who switch regimens, and those with renal impairment. The NDA for E/C/F/TAF is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead's Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) among treatment-naïve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild.
TAF is an investigational, novel prodrug of tenofovir, the active agent in Viread (tenofovir disoproxil fumarate).
For more information call (800) 445-3235 or visit Gilead.com.