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ARTICLE | Clinical News

Complera: Phase IIIb data

December 10, 2012 8:00 AM UTC

The open-label Phase IIIb STaR (Study 110) trial in 786 treatment-naïve patients with HIV infection showed that once-daily Complera met the primary endpoint of non-inferiority to Atripla emtricitabine/tenofovir/efavirenz in the proportion of patients who achieved HIV RNA levels <50 copies/mL at week 48 (86% vs. 82%, 95% CI for the difference: -1.1%, 9.2%). The predefined criterion for non-inferiority was a lower bound of a 2-sided 95% CI of -12%. In patients with a baseline viral load of <=100,000 copies/mL, 89% of patients receiving Complera achieved HIV RNA levels <50 copies/mL vs. 82% for Atripla. In patients with baseline viral load of >100,000 copies/mL, 80% of patients receiving Complera achieved HIV RNA levels <50 copies/mL vs. 82% for Atripla. The virologic failure rate, defined as failing to achieve a viral load of <50 copies/mL at week 48 or discontinuing treatment prior to week 48 with last available viral load showing >=50 copies/mL, was 8% in the Complera arm and 6% in the Atripla arm. Additionally, increases in CD4+ cell counts were similar between treatment groups at week 48 (200 vs. 191 cells/mm 3, p=0.34). Data were presented at the Drug Therapy in HIV Infection meeting in Glasgow. ...