FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) announced Monday that the U.S. Food and Drug Administration or FDA has approved Stribild, a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
Stribild, referred to as 'Quad' prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate.
Applications for marketing approval of Stribild are also pending in Australia, Canada and the European Union, the company said.
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. The company said that Stribild does not cure HIV-1 infection.
The company stated that Stribild has Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B.
The company added that Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Stribild have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Stribild.
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