Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Gilead Sciences has reported positive data from Single Tablet Regimen (STaR) Phase 3b study comparing Complera and Atripla among treatment-naive HIV patients.
Subscribe to our email newsletter
Data demonstrated that Complera is non-inferior to Atripla, achieving HIV RNA levels less than 50 copies/mL through 48 weeks of therapy, the primary endpoint of the study.
On the basis of FDA snapshot algorithm, 86% of Complera administered patients achieved HIV RNA levels less than 50 copies/mL compared to 82% of Atripla group patients.
STaR study principal investigator, Community Research Initiative of New England director of research Calvin Cohen said the rate of viral suppression demonstrated by Complera in the study is notable as Atripla has become a standard of HIV care since its approval in 2006.
"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," Cohen added.
A statistically considerable difference in efficacy of Complera in low baseline viral load patients and non-inferiority among high baseline viral load patients was reported as compared to Atripla.
The randomized (1:1), open-label study, in which Complera was well-tolerated, reported a low virologic failure rate that was similar between Complera and Atripla.
Complera is a combination of Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) and Janssen R&D Ireland’s rilpivirine.