Gilead Sciences has filed a NDA for a once-daily single tablet containing bictegravir (50 mg), a novel integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) to treat HIV-1 infection.

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.

BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials among treatment-na�ve adult patients and among virologically suppressed adult patients who switched regimens. The NDA for BIC/FTC/TAF is supported by data from four Phase III studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg) among treatment-na�ve patients and among virologically suppressed patients (HIV-1 RNA levels <50 copies ml switching from an existing antiretroviral regimen with dolutegravir. a fourth ongoing study in virologically suppressed patients compares switching to bic ftc taf versus remaining on a suppressive regimen of two nucleoside nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.>

Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.