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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

ith regard to efficacy, lipid effects, safety and tolerability. Additional study results include:

Achievement of Undetectable Viral Load in Patients with High Baseline Viral Load
* In the study, 74 percent of the 223 patients with high baseline viral

load (greater than or equal to 100,000 copies/mL) in the once-daily

REYATAZ(R) (atazanavir sulfate)/r arm achieved undetectable viral load

at 48 weeks, vs. 72 percent of the 225 patients with high baseline

viral load in the twice-daily lopinavir/r arm.

Immunologic Response

* The mean increase in CD4+ count from baseline at 48 weeks was

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 had total cholesterol greater than or

equal to 240 mg/dL.

* Less than one percent of patients in the REYATAZ/r arm vs. four percent

of patients in the lopinavir/r arm had triglyceride levels greater than

or equal to 751 mg/dL.

Safety and Tolerability

* 26% of patients in the REYATAZ/r arm and 30% of patients in the

lopinavir/r arm experienced any grade 2-4 treatment-related adverse

event.

* The incidence of treatment discontinuation due to adverse events was

two percent in the REYATAZ/r arm and three percent in the lopinavir/r

arm.

* Renal adverse events of any grade were experienced in two percent of

patients in both treatment arms.

* 34% of patients in the once-daily REYATAZ/r arm and less than 1% of

patients in the twice-daily lopinavir/r arm experienced elevations in

total bilirubin greater than 2.5 times the upper limit of normal.

* The rates of grade 3-4 liver enzyme elevations (greater than 5 times

the upper limi
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SOURCE Bristol-Myers Squibb Company
Copyright©2008 PR Newswire.
All rights reserved

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Supplied sterile in peel-open packages. Intended for one-time use....
Used for percutaneous nephrostomy. Supplied sterile in peel-open packages. Intended for one-time use....
Used as a percutaneous entry needle to introduce wire guides. The coaxial design reduces potential A.V. malformations. Supplied sterile in peel-open packages. Intended for one-time use....
Used under fluoroscopy for initial location and positioning of the renal collecting system throughout a percutaneous nephrostomy. Supplied sterile in peel-open packages. Intended for one-time use....
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