US FDA has approved Reyataz plus ritonavir combo for HIV-1

US drug major Bristol-Myers Squibb says that the Food and Drug Administration has approved Reyataz (atazanavir sulfate) 300mg once-daily plus ritonavir 100mg as part of combination therapy in previously untreated HIV-1 patients. For treatment-naive patients who are unable to tolerate ritonavir, Reyataz 400mg (without ritonavir), taken once daily with food, is recommended. The approval is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of Reyataz/r to twice-daily lopinavir/ritonavir, each as part of HIV combination therapy, in treatment-naive HIV-1 adult patients. Within the CASTLE study, the Reyataz/r arm was associated with low increases from baseline in total cholesterol (13%), LDL cholesterol (14%), HDL cholesterol (29%) and triglycerides (15%). The lopinavir/r cohort saw a 25% increase in total cholesterol, a 19% rise in LDL cholesterol, and a 37% increase in HDL cholesterol.