Fixed-dose combination HIV treatment filed for US approval

A New Drug Application has been submitted to the US Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50mg) (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.

US biotech major Gilead Sciences’ (Nasdaq: GILD) 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-naïve adult patients and among virologically suppressed adult patients who switched regimens.

"We aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone," said Norbert Bischofberger, executive vice president R&D and chief scientific officer, Gilead Sciences.

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 (5mg) among treatment-naïve 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.