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|Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment|
– Investigational Single Tablet Regimen May Have Potential to
Advance Triple-therapy HIV Treatment for a
“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
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 (50mg) among treatment-naïve patients and among virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) 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 authorization application for
BIC/FTC/TAF in the
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.
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including
For more information on
Gilead Sciences, Inc.
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