Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
The Phase 3 Study, Study 145 was a double-blind, multicenter, randomized (1:1), active-controlled, 96-week clinical trial evaluating the non-inferiority of elvitegravir versus raltegravir.
The patients received either once-daily elvitegravir (150 mg or 85 mg) or twice-daily raltegravir 400 mg.
As the 48 weeks study met non-inferiority endpoint, patients continued to receive the regimen to which they were randomized in a blinded fashion through 96 weeks.
The secondary endpoints include additional measures of the efficacy, safety and tolerability of the two treatment regimens.
The company intends to file for US regulatory approval of elvitegravir in the second quarter of 2012.