Gilead Sciences has reported positive results from a Phase III trial evaluating elvitegravir, its investigational anti-retroviral agent, as a treatment for HIV-1 infection in treatment-experienced patients.
The trial met the primary endpoint, which was defined as non-inferiority of once-daily elvitegravir compared to twice-daily raltegravir, at week 48.
The study results showed responses at 48 weeks met the statistical criteria of non-inferiority when compared to raltegravir based on the proportion of subjects who achieved and maintained HIV RNA levels (viral load) of less than 50 copies/ml.
About 59% of patients in the elvitegravir arm achieved and maintained a viral load of less than 50 copies/ml through week 48, compared with 57.8% in the raltegravir arm.
Discontinuation rates due to adverse events were comparable in both arms of the study.
The randomised, double-blind, 48-week clinical trial was designed to evaluate the non-inferiority of elvitegravir versus raltegravir, each administered with a background regimen.
The study enrolled HIV-infected treatment-experienced adults with HIV RNA of greater than or equal to 1,000 copies/ml.
The study is ongoing in a blinded fashion and the secondary endpoints include various additional measures of the efficacy, safety and tolerability of the two treatment regimens.
Elvitegravir, an HIV integrase inhibitor, was licensed by Gilead from Japan Tobacco in March 2005.