Gilead Sciences says that its once-daily HIV drug elvitegravir hit its primary endpoint in a late-stage study, demonstrating its non-inferiority to Merck's twice-daily Isentress after 48 weeks of treatment. Investigators also concluded that discontinuation rates were comparable, helping Gilead gain a leg up over the competition. And Gilead, a leader in the HIV field, says that the fresh batch of positive data for the drug--also part of its new Quad therapy--represents a big step forward in its quest for near-term marketing approval.
After 48 weeks of treatment elvitegravir met the statistical criteria of non-inferiority as compared to Isentress (raltegravir) based on the proportion of subjects who achieved and maintained a viral load of less than 50 copies/mL, according to a statement from the company. All of the patients were given a background regimen that included a ritonavir-boosted protease inhibitor and a second antiretroviral agent. Discontinuation rates due to adverse events were comparable in both arms of the study. Gilead plans to submit these data for presentation at a scientific conference later this year.
"We are very pleased to have achieved the primary endpoint in this clinical trial, as data from this study will support regulatory filings for elvitegravir as well as Gilead's investigational Quad pill," said Norbert Bischofberger, PhD, the head of R&D and CSO at Gilead. "By analyzing these data now we will be in a better position to advance filings as quickly as possible once data from subsequent Phase III clinical trials in our Quad development program become available later this year."
- here's the Gilead release