Bictegravir/FTC/TAF: new once-daily integrase-based FDC submitted to US FDA
Simon Collins, HIV i-Base
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 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-drug interactions that affect bictegravir are likely to be dependent on 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 during 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).