Gilead Submits NDA for Triple-Therapy, Single Tablet HIV Regimen

hiv virus
hiv virus
Gilead submitted their single-tablet regimen containing bictegravir, emtricitabine, and tenofovir alafenamide for HIV-1 treatment to the FDA.

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.  

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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.

This article originally appeared on MPR