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

The investigational tablet contains bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg
The investigational tablet contains bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg

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.  

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“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.