NEW YORK -- October 2, 2008 -- The US Food and Drug Administration has approved atazanavir sulfate (Reyataz) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in treatment-naïve HIV-1 infected patients.
The approval is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of atazanavir/ritonavir (atazanavir/r) sulfate to twice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIV combination therapy, in treatment- naïve HIV-1 infected adult patients.
Within the CASTLE study, the atazanavir/r arm was associated with low increases from baseline in total cholesterol (13%), low-density lipoprotein cholesterol (14%), high-density lipoprotein cholesterol (29%), and triglycerides (15%).
Two percent of patients in the atazanavir/r arm and 8% of patients in the lopinavir/r arm required lipid-lowering therapy in the study, compared with 1% in each arm at baseline.
Grade 2 to 4 adverse events that occurred in 2% or greater of patients in the CASTLE study included jaundice, nausea, diarrhoea, and rash. Grade 3 to 4 increases in total bilirubin were seen in 34% of patients in the atazanavir/r arm and in less than 1% of patients in the lopinavir/r arm.
SOURCE: Bristol-Myers Squibb
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