CASTLE Study Showed Similar Efficacy Between Once-Daily REYATAZÃ (atazanavir Sulfate)/ritonavir And Twice-Daily Lopinavir/ritonavir Part 3
Thursday, May 29th, 2008Immunologic Response — The connote magnify contained with CD4+ relay from baseline at 48 weeks be 203 cells/mm3 in patients in the REYATAZ/r arm and 219 cells/mm3 in patients in the lopinavir/r arm.
Lipid Effects — Seven percent of patients in the REYATAZ/r arm vs. eighteen percent of patients in the lopinavir/r arm have recompense cholesterol greater than or the same to 240 mg/dL.
AZILECT(R) be approved by the Food & Drug Administration May 17, 2006, foot next to background from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical study, which built-in higher than 1,500 patients.
Safety and Tolerability — 26% of patients in the REYATAZ/r arm and 30% of patients in the lopinavir/r arm knowing any order 2-4 treatment-related adverse thing.
— The amount of control discontinuation in the red to adverse business was two percent in the REYATAZ/r arm and three percent in the lopinavir/r arm.
— Renal adverse events of any grade be experienced in two percent of patients in both treatment guns.
— 34% of patients in the once-daily REYATAZ/r arm and smaller quantity than 1% of patients in the twice-daily lopinavir/r arm experienced elevation all tell bilirubin greater than 2.5 times the maximum of regular.
— The rates of grade 3-4 liver enzyme elevations (greater than 5 times the upper observe of normal) were the same relating treatment arms. — Grade 3-4 ALT elevations: 2% in the once-daily REYATAZî (atazanavir sulfate)/r arm vs. 1% in the twice-daily lopinavir/r arm — Grade 3-4 AST elevations: 2% in the REYATAZ/r arm vs. less than 1% in the lopinavir/r arm A prespecified advisory analysis of virologic riposte rates (HIV-1 RNA less than 50 copies/mL) by baseline CD4+ category (greater than 200 cells/mm3, between 100 and 200 cells/mm3, between 50 and 100 cells/mm3, and less than 50 cells/mm3) symbolize that response rates were homogeneous across all baseline CD4+ categories in the REYATAZ/r arm. This descriptive analysis indicated that response rates were reduced all for field near humiliate CD4+ count in the lopinavir/r arm. A repositioning hoc analysis show no company between virologic response rates and CD4+ category inwardly the REYATAZ/r arm (p = 0.51) and a statistically imperative association between virologic response rates and CD4+ category within the lopinavir/r arm (p = 0.0085).
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