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news.Gilead Sciences has reported positive data from its Phase 3 clinical trial which evaluated the efficacy of cobicistat, a pharmacoenhancing or boosting agent as compared to ritonavir.
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Cobicistat, a quad single-tablet regimen is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
The Study 114 is a randomized, double-blind, Phase 3 clinical trial comparing the efficacy and safety of cobicistat-boosted atazanavir versus ritonavir-boosted atazanavir, each administered with Truvada, over a 96-week period.
HIV-infected treatment-naive adults were randomized (1:1) to receive a regimen of cobicistat 150 mg, atazanavir 300 mg and Truvada (n=344) or ritonavir 100 mg, atazanavir 300 mg and Truvada.
The primary endpoint of the study was the proportion of patients achieving HIV RNA levels of less than 50 copies/mL at 48 weeks of treatment.
Secondary objective is assessing efficacy, safety and tolerability of the treatment regimens through 96 weeks of treatment.