Gilead Science's fixed-dose combination of bictegravir and emtricitabine/tenofovir alafenamide has been granted an NDA for the treatment of HIV infection.
The US Food and Drug Administration (FDA) has accepted Gilead Sciences' New Drug Application (NDA) for an investigational, fixed dose combination of 2 drugs for HIV infection treatment.
Bictegravir (BIC), an investigational integrase strand transfer inhibitor; and emtricitabine/tenofovir alafenamide (FTC/TAF), a dual-NRTI backbone are known in combination as BIC/FTC/TAF.
An action date has been set for February 18, 2018, under the Prescription Drug User Fee Act (PDFUA). Gilead filed the NDA with a priority review voucher on June 12, according to a Gilead press release.
Gilead’s NDA was supported by 4 Phase 3 studies done to evaluate a fixed-dose combination of BIC/FTC/TAF with treatment-naïve and biologically suppressed patients.
The trial compared a once-daily 75 mg BIC tablet paired with a 200/25 mg FTC/TAF once-daily tablet against a fixed-dose combination Dolutegravir (DTG) placebo for a length of 48 weeks. After Week 48, the patients were asked to continue with their treatment and attend visits every 12 weeks until the treatment options were unblinded.
Gilead announced that the trial had met its primary endpoint on May 30, stating that “BIC/FTC/TAF met the definition of non-inferiority in all four studies, with comparable proportions of patients having HIV-1 RNA <50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥50 copies/mL (Studies 1844 and 1878),” in a press release.
"Since the approval of Viread 16 years ago, Gilead has continually worked to develop and improve treatments for people living with HIV. This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the FTC/TAF backbone,” Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead Sciences, said in a press release at the time. “Based on the results from these Phase 3 studies, the combination of bictegravir and FTC/TAF could represent an important advance in triple-therapy treatment for a broad range of HIV patients, and we look forward to submitting regulatory applications in the U.S. and EU this year.”
BIC/FTC/TAF is currently under marketing review in the European Union, after being validated by the European Medicines Agency (EMA) in July 2017.