Median changes from baseline in total cholesterol, HDL and LDL at 96 weeks, were, respectively, +14, +6 and +14 mg/dL for Stribild, and +8, +5 and +11 mg/dL for the atazanavir-based regimen (total cholesterol, p=0.046; HDL, p=0.24; LDL, p=0.32). The median change in triglycerides was +5 mg/dL for Stribild and +16 mg/dL for the atazanavir-based regimen (p=0.012).
Studies 102 and 103 are ongoing in a blinded fashion. After week 192, patients will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all subjects will be given the option to participate in an open-label rollover extension and receive Stribild. Additional information about the study can be found at www.clinicaltrials.gov.
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 in the United States as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. A Marketing Authorisation Application (MAA) for the regimen was validated for review by the European Medicines Agency (EMA) on December 20, 2011. 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 from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir as a standalone agent on June 27, 2012, and the agency has set a target action date under the Prescription Drug User Fee Act (PDUFA) of April 27, 2013. An MAA for elvitegravir in the EU was validated for review by EMA on June 18, 2012.
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