Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

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 four 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 two 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.  

For more information visit Gilead.com.