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New Drug Application Submitted to FDA for Single-Tablet HIV Regimen
A new drug application (NDA) has been submitted to the FDA for an investigational, once-daily single tablet containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults.
According to the product’s developer (Gilead Sciences), the data submitted in the NDA support the use of the regimen in adult and adolescent treatment-naïve HIV-infected individuals, in virologically suppressed patients who switch regimens, and in those with renal impairment. If approved, E/C/F/TAF would be the first single-tablet regimen to contain TAF.
TAF is an investigational prodrug of tenofovir, the active agent in Viread (tenofovir disoproxil fumarate, Gilead Sciences). TAF is a more targeted form of tenofovir than that found in Viread, and it has demonstrated high antiviral efficacy at a dose that is 10 times lower, as well as improved renal and bone safety profiles.
The NDA for E/C/F/TAF was supported by 48-week data from two pivotal phase III studies in which the regimen met its primary objective of non-inferiority compared with Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg, Gilead Sciences) in treatment-naïve HIV patients. In these studies, E/C/F/TAF demonstrated improved renal and bone safety compared with Stribild.
The NDA was also supported by data from additional phase III studies that evaluated the TAF-based regimen in virologically suppressed HIV patients who switched to E/C/F/TAF and in patients with renal impairment.
Source: Gilead Sciences; November 6, 2014.