Gilead Sciences (Nasdaq:GILD) today announced Phase 3b clinical trial results from STaR ( Single Tablet Regimen), the first head-to-head study comparing the single tablet regimens Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) and Atripla ® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) in treatment-naïve adults with HIV infection. Data demonstrated that Complera, which is marketed as Eviplera ® in the European Union, is non-inferior to Atripla based on the proportion of patients with HIV RNA levels (viral load) < 50 copies/mL at 48 weeks.
Complera demonstrated a statistically significant difference in efficacy compared to Atripla among patients with low baseline viral load (≤ 100,000 copies/mL), and was non-inferior to Atripla among patients with high baseline viral load (> 100,000 copies/mL). Notably, the virologic failure rate was low and comparable between Complera and Atripla, including among patients with baseline viral load up to 500,000 copies/mL. In addition, Complera was well-tolerated with fewer adverse events across all grades and fewer discontinuations due to adverse events (3 percent versus 9 percent; p<0.001) in the Complera and Atripla arms, respectively. These results were presented today in an oral session at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) in Glasgow, United Kingdom.
“Since its U.S. approval in 2006, Atripla has become a standard of HIV care, so the rate of viral suppression demonstrated by Complera in this study is impressive,” said Calvin J. Cohen, MD, M.Sc., Director of Research, Community Research Initiative of New England and principal investigator of the STaR study. “Further, these data reinforce the tolerability profile of Complera and support its role as an important single tablet treatment option for many HIV patients new to therapy.”
At week 48, 86 percent of patients taking Complera (n=338/394) compared to 82 percent of patients taking Atripla (n=320/392) achieved HIV RNA levels < 50 copies/mL based on the U.S. Food and Drug Administration (FDA) snapshot algorithm (95 percent CI for the difference: -1.1 percent to +9.2 percent; predefined criterion for non-inferiority was the lower bound of a two-sided 95 percent CI of -12 percent). Among patients with baseline viral load ≤ 100,000 copies/mL, 89 percent of Complera patients (n=231/260) compared to 82 percent of Atripla patients (n=204/250) achieved viral suppression to < 50 copies/mL (95 percent CI for the difference: 1.1 percent to 13.4 percent). Among patients with baseline viral load > 100,000 copies/mL, 80 percent of Complera patients (n=107/134) and 82 percent of Atripla patients (n=116/142) achieved viral suppression to < 50 copies/mL (95 percent CI for the difference: -11.1 percent to 7.5 percent).