Bictegravir/FTC/TAF: New Once-Daily Integrase-Based Fixed-Dose Combination Submitted to U.S. FDA
On 12 June 2017, Gilead Sciences submitted a new drug application to the US FDA for a single tablet fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
Bictegravir (formerly GS-9883) is a potent once-daily integrase inhibitor, with mean plasma concentration more than 20 x above the IC95 at 24 hours and low intrapatient differences. It is used at low milligram dose (50 mg) leading to a small pill with TAF. Bictegravir has a plasma half-life of 18 hours, doesn't need PK boosting and can be taken with or without food.
Potential drug interactions that affect bictegravir are likely to be dependent of inhibition or induction of both CYP3A4 and UGT1-A1 with little expected effect of bictegravir on other drugs.
The application is based on non-inferiority results from four phase 3 studies. These include a treatment naive study compared to dolutegravir and several switch studies in people with viral suppression on current treatment.
A similar submission to the European Medicines Agency (EMA) is planned for 3Q 2017.
Gilead press statement. Gilead submits new drug application to U.S. food and drug administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment. (12 June 2017).