|View printer-friendly version|
|Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens|
– Bictegravir-Containing Regimen Found to Be Non-Inferior to Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adult Patients with HIV–
– No Patients in Bictegravir Treatment Arm Demonstrated Treatment-Emergent Resistance Through 48 Weeks –
“These data demonstrate the potential of BIC/FTC/TAF to match the
efficacy of a boosted protease inhibitor regimen while also offering a
high barrier to resistance and fewer interactions with other drugs,”
In Study 1878, a total of 577 virologically suppressed adults with HIV
taking regimens of boosted atazanavir (ATV) or darunavir (DRV) +
No patients in the BIC/FTC/TAF arm developed treatment-emergent
resistance, and one participant on DRV/ritonavir +
“The combination of the unboosted integrase inhibitor bictegravir with
the FTC/TAF backbone has the potential to further evolve HIV triple
therapy with convenient dosing in a single-tablet regimen,” said
Gilead filed a New Drug Application for BIC/FTC/TAF with a Priority
Review voucher on
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.
Further information about the clinical trials can be found at www.clinicaltrials.gov.
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City,
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 the
possibility that regulatory authorities, including the
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Minimum 20 minute delay