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CASTLE Study Showed Similar Efficacy Between Once-Daily REYATAZ(R) (atazanavir sulfate)/ritonavir and Twice-Daily lopinavir/ritonavir at 48 Weeks in Previously Untreated HIV-Infected Adult Patients
Date:2/6/2008

in the once-daily REYATAZ(R) (atazanavir sulfate)/r arm or the twice-daily lopinavir/r arm were diarrhea (two percent and eleven percent, respectively) nausea (four percent and eight percent, respectively), jaundice (four percent and zero percent, respectively) and rash (three percent and two percent, respectively).

The REYATAZ/r arm was associated with significantly lower increases from baseline compared to the lopinavir/r arm in total cholesterol, triglycerides and non-HDL cholesterol at 48 weeks (p<0.0001). Two percent of patients in the REYATAZ/r arm and seven percent of patients in the lopinavir/r arm required initiation of lipid-lowering therapy in the study.

Safety events in this study were consistent with prior experience. Four deaths were reported in each treatment arm at 48 weeks; none were attributed to the study medications. Twelve percent of patients in the REYATAZ/r arm and ten percent of patients in the lopinavir/r arm experienced a serious adverse event.

Nine percent of patients in the REYATAZ/r arm and thirteen percent of patients in the lopinavir/r arm discontinued the study therapy before week 48.

About the CASTLE Study

The international, multi-center, open-label, 96-week CASTLE study randomized 883 treatment-naive patients infected with HIV-1. Four hundred and forty patients were randomized to receive REYATAZ 300 mg and ritonavir 100 mg once daily and 443 patients were randomized to receive lopinavir 400 mg and ritonavir 100 mg twice daily, each in combination with a once-daily, fixed- dose combination of emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg. All patients had a baseline viral load of greater than or equal to 5,000 copies/mL; there was no CD4+ cell count restriction for study entry. The primary endpoint for the study was the proportion of patients with viral load of less than 50 copies/mL at 48 weeks.

Additional Study Results

A number of secondary endpoints were also measured w
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SOURCE Bristol-Myers Squibb Company
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