Gilead Submits NDA for Triple-Therapy, Single Tablet HIV Regimen
The NDA included data from 4 Phase 3 studies where BIC/FTC/TAF met the primary objective of non-inferiority.
Gilead announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for a single-tablet regimen containing bictegravir, emtricitabine, and tenofovir alafenamide, for the treatment of adults with HIV-1 infection.
The investigational tablet contains bictegravir (BIC) 50mg, a novel integrase strand transfer inhibitor, emtricitabine (FTC) 200mg and tenofovir alafenamide (TAF) 25mg, both nucleoside analogue reverse transcriptase inhibitors.
The NDA included data from 4 Phase 3 studies where BIC/FTC/TAF met the primary objective of non-inferiority. Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.
The fourth ongoing study, involving virologically-suppressed patients, is evaluating switching to BIC/FTC/TAF vs remaining on a suppressive regimen of 2 nucleoside/nucleotide reverse transcriptase inhibitors + boosted protease inhibitor.
“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, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.
Gilead submits new drug application to US Food and Drug Administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment [press release]. Foster City, California: Gilead. Published June 12, 2017. Accessed June 28, 2017.