Stribild, a complete once-daily single tablet regimen for treatment-naïve adults with HIV-1 infection, approved by FDA
The FDA ( Food and Drug Administration ) has approved Stribild ( Elvitegravir 150 mg / Cobicistat 150 mg / Emtricitabine 200 mg / Tenofovir disoproxil fumarate 300 mg ), 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.
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 ).
Stribild is the third single tablet HIV regimen developed by Gilead. The first, Atripla, was approved in 2006. The second single tablet regimen, Complera ( Emtricitabine / Rilpivirine / Tenofovir disoproxil fumarate ), which combines Truvada and Rilpivirine, was approved in 2011.
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.
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.
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. ( Xagena )
Source: Gilead, 2012
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