Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide filed with FDA for HIV-Gilead Sciences

Gilead Sciences has submitted a New Drug Application to the FDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult and adolescent treatment-na�ve 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 III studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead�s Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-na�ve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild.

The NDA is also supported by data from additional Phase III studies evaluating the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF and among patients with renal impairment. In addition, the filing is supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components and the co-formulated single tablet regimen. Gilead plans to submit a regulatory application for E/C/F/TAF in the European Union by the end of 2014.