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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

Data also showed differences in gastrointestinal and lipid effects between

REYATAZ/ritonavir and lopinavir/ritonavir among study population

PRINCETON, N.J., Feb. 6 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced results from the CASTLE study, in which 300 mg of once-daily REYATAZ(R) (atazanavir sulfate) taken with 100 mg of ritonavir (REYATAZ/r) showed similar antiviral efficacy to twice-daily lopinavir 400 mg and ritonavir 100 mg (lopinavir/r) in previously untreated adult HIV-1 infected patients at 48 weeks, as part of HIV combination therapy. In this study, 78 percent of the 440 patients in the REYATAZ/r arm met the primary endpoint of achieving undetectable viral load (defined as HIV-1 RNA less than 50 copies/mL) at 48 weeks, compared with 76 percent of the 443 patients in the lopinavir/r arm.

CASTLE is the first large-scale, open-label, randomized study designed to demonstrate the non-inferiority of REYATAZ/r to lopinavir/r in previously untreated HIV-1 infected adult patients. Data from the CASTLE study were presented for the first time at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) this week in Boston, Mass.

"The CASTLE study provides important additional data to inform the use of a once-daily regimen including REYATAZ and ritonavir in antiretroviral-naive HIV-infected patients," said Jean-Michel Molina, M.D., Hopital Saint Louis, Paris, France. "When choosing a treatment in previously untreated patients it is important to ensure antiviral activity as well as tolerability to optimize the management of HIV infection over the long term."

The most common grade 2-4 adverse events occurring in greater than or equal to three percent of patients
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SOURCE Bristol-Myers Squibb Company
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