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.

RELATED: New Combo Tablets Approved for HIV-1 Infection

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.