Virologic failure per snapshot algorithm was defined as patients failing to achieve viral load < 50 copies/mL at week 48, or discontinuing study drug prior to this time point due to lack of efficacy, or discontinuing study drug for other reasons and with last available viral load showing ≥ 50 copies/mL. Virologic failure rates for Complera and Atripla were, respectively, 5 percent and 3 percent for patients with viral load ≤ 100,000 copies/mL; 10 percent and 9 percent for patients with viral load > 100,000 to 500,000 copies/mL; and 25 percent and 16 percent for patients with viral load > 500,000 copies/mL.Complera was approved in the United States in August 2011 and is indicated for use as a complete regimen for treatment-naïve adults with HIV-1 infection. Complera combines Gilead’s Truvada ® (emtricitabine and tenofovir disoproxil fumarate) with Janssen R&D Ireland’s rilpivirine (marketed as Edurant ®). In previous studies, more rilpivirine-treated patients with viral load > 100,000 copies/mL at the start of therapy experienced virologic failure compared to those with viral load < 100,000 copies/mL. Complera has Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for important safety information.
Gilead’s Complera® Non-Inferior To Atripla® Among Treatment-Naïve HIV Patients
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