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.
Complera received marketing authorization from the European Commission as Eviplera in November 2011, becoming the first single tablet regimen approved for patients new to HIV therapy in Europe. In November 2012, Eviplera was added to European AIDS Clinical Society (EACS) treatment guidelines as a recommended regimen for treatment-naïve HIV patients.
About STaRSTaR (Study 110) is an ongoing, randomized (1:1), open-label Phase 3b study evaluating the efficacy and safety of Complera (n=394 treated) compared to Atripla (n=392 treated) among treatment-naïve HIV-positive adults with baseline HIV RNA levels ≥ 2,500 copies/mL. The primary objective of the study is to evaluate the non-inferiority, at a 12 percent margin, of Complera compared to Atripla in achieving HIV RNA levels < 50 copies/mL through 48 weeks of therapy, based on the FDA snapshot algorithm. Secondary endpoints include safety and efficacy of change from baseline in CD4 cell count at weeks 48 and 96 of therapy, and development of genotypic and phenotypic resistance at the time of virologic failure. Randomization was stratified by baseline HIV RNA levels (≤ or > 100,000 copies/mL).