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|U.S. FDA Approves Gilead’s Stribild™, a Complete Once-Daily Single Tablet Regimen for Treatment-Naïve Adults with HIV-1 Infection|
– Stribild is Gilead’s Third Single Tablet Regimen for the Treatment of HIV and the First to Contain an Integrase Inhibitor –
“Over the past decade, co-formulated HIV medicines have simplified
therapy for many patients and have become standard of care,” said
The approval of Stribild is supported by 48-week data from two pivotal Phase 3 studies in which the single tablet regimen met its primary objective of non-inferiority compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada® (emtricitabine/tenofovir disoproxil fumarate) (Study 103). Today’s approval is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of Stribild and the co-formulated single tablet regimen.
“For much of the company’s 25-year history, Gilead has focused on the
development of improved treatments and simplified regimens for HIV,”
Stribild is the third single tablet HIV regimen developed by Gilead. The
first, Atripla, was approved in 2006 and is marketed by Gilead and
In all studies of Stribild, most adverse events were mild to moderate. Stribild has Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for important safety information.
Applications for marketing approval of Stribild are also pending in
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance
to patients in
For patients with private insurance, Gilead’s co-pay coupon program
provides assistance with out-of-pocket expenses for Gilead’s HIV
medications, including Stribild, starting at the first dollar.
Additionally, Gilead is working closely with the
Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg. Stribild is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. Stribild does not cure HIV-1 infection.
Elvitegravir is a member of the integrase inhibitor class of
antiretroviral compounds. Integrase inhibitors interfere with HIV
replication by blocking the ability of the virus to integrate into the
genetic material of human cells. Elvitegravir was licensed by Gilead
Cobicistat is a pharmacoenhancing or “boosting” agent that enables
elvitegravir once-daily dosing. It is a potent mechanism-based inhibitor
of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the
body. Cobicistat acts only as a pharmacoenhancer and has no antiviral
activity. Gilead submitted an NDA to
Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established.
Important Safety Information about Stribild
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and Precautions
Dosage and Administration
Pregnancy and Breastfeeding
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 that physicians and patients may not see advantages of Stribild
over other therapies and may therefore be reluctant to prescribe the
product, and the risk that public payers may be reluctant to approve or
provide reimbursement for the product. In addition, pending marketing
applications for Stribild, including in the
Advancing Access, Complera, Stribild and Truvada are trademarks or
registered trademarks of
Atripla is a registered trademark of
For more information on
Gilead Sciences, Inc.
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