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|European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)|
– In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks –
BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone.
“Triple therapy has been the standard of HIV treatment for more than 20
years and has allowed people living with HIV to achieve durable
undetectability. At Gilead, we have continued to explore ways to improve
and provide more HIV treatment options, with the goal of going beyond
reducing viral load and helping to address some of the wider challenges
faced by people living with HIV,” said
The MAA for BIC/FTC/TAF is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks in all four studies.
The CHMP’s recommendation will now be reviewed by the
BIC/FTC/TAF was approved by the
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention 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 generic 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 the risk
Biktarvy, Descovy, Gilead and the Gilead logo are trademarks of
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Gilead Sciences, Inc.
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