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FDA Approves Four-Drug Tablet for Treatment of HIV Infection
Gilead Sciences, Inc., headquartered in Foster City, Calif., announced on August 27 that the FDA has approved Stribild, a once-daily tablet for human immunodeficiency virus-1 (HIV-1) infection in treatment-naïve adults. Stribild, known as “Quad” prior to FDA approval, combines four compounds in one tablet: elvitegravir (an integrase inhibitor) 150 mg; cobicistat (a pharmacoenhancing agent) 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg.
Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI), is marketed as Emtriva, and tenofovir disoproxil fumarate, another NRTI, is marketed as Viread.
The approval of Stribild is supported by 48-week data from two pivotal phase III studies in which the single-tablet regimen met its primary objective of noninferiority compared with Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and compared with a regimen containing ritonavir-boosted atazanavir plus Truvada (emtricitabine/tenofovir disoproxil fumarate) (Study 103).
Stribild is the third single-tablet HIV regimen developed by Gilead. The first, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the U.S. The second single-tablet regimen, Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), which combines Gilead’s Truvada and Janssen R&D Ireland’s rilpivirine, was approved in 2011.
The prescribing information for Stribild includes Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.
Stribild is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. The multidrug tablet 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.
Cobicistat is a pharmacoenhancing or “boosting” agent that enables once-daily dosing of elvitegravir. 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.
Elvitegravir and cobicistat as stand-alone agents are investigational products, and their safety and efficacy have not been established.
For more information, visit the Gilead Pharmaeuticals Web site.