Gilead Sciences announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (BIC), a novel investigational integrase strand transfer inhibitor (formerly GS-9883), and emtricitabine (FTC)/tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in adults.
BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens.
The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir among treatment-naive patients and among virologically suppressed patients switching from an existing antiretroviral regimen with dolutegravir. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.
Gilead plans to submit a marketing authorisation application for BIC/FTC/TAF in the European Union in Q3. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.
It is presently unknown when Gilead plans to submit an application to the Australian Therapeutic Goods Administration (TGA) for Bictegravir in this triple combination single tablet regimen.
Source: Adapted from https://thefly.com/landingPageNews.php?id=2565018 Gilead submits NDA for Bictegravir, Emtricitabine, Tenofovir Alafenamide regimen. Accessed 13 June, 2017 Read the Gilead Press Release: http://www.gilead.com/news/press-releases/2017/6/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-fixeddose-combination-of-bictegravir-emtricitabine-and-tenofovir-alafenamide-for-hiv-treatment