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FDA Approves Use of Atazanavir-Ritonavir Combo in Previously Untreated HIV-1 Infected Patients

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) announced today that the U.S. Food & Drug Administration (FDA) approved the use of REYATAZ® (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients. REYATAZ boosted with ritonavir (REYATAZ/r) taken once daily with food is recognized by the U.S. Department of Health and Human Services (DHHS) as a preferred component of combination HIV therapy for treatment-naive patients.

For treatment-naive patients who are unable to tolerate ritonavir, REYATAZ 400 mg (without ritonavir), taken once daily with food, is recommended.

This use of once-daily REYATAZ/r in HIV-1 infected treatment-naive adult patients is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of REYATAZ/r to twice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIV combination therapy, in treatment-naive HIV-1 infected adult patients.

Within the CASTLE study, the REYATAZ/r arm was associated with low increases from baseline in total cholesterol (13 percent), LDL cholesterol (14 percent), HDL cholesterol (29 percent), and triglycerides (15 percent). The lopinavir/r arm was associated with 25 percent increase in total cholesterol, 19 percent increase in LDL cholesterol, 37 percent increase in HDL cholesterol, and 52 percent increase in triglycerides. Two percent of patients in the REYATAZ® (atazanavir sulfate)/r arm and eight percent of patients in the lopinavir/r arm required lipid-lowering therapy in the study, compared to 1 percent in each arm at baseline.

Safety events in this study were consistent with prior experience. Grade 2-4 treatment-related adverse events that occurred in two percent or greater of patients in the CASTLE study included jaundice (4 percent and zero percent), nausea (4 percent and 8 percent), diarrhea (2 percent and 11 percent) and rash (3 percent and 2 percent) in the REYATAZ/r and lopinavir/r arms, respectively. Grade 3–4 increases in total bilirubin were seen in 34 percent of patients in the REYATAZ/r arm and in less than 1 percent of patients in the lopinavir/r arm.

“Bristol-Myers Squibb is committed to developing medicines that enhance the care of people living with HIV and AIDS,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. “Boosted REYATAZ provides health care professionals a newly approved, once-daily dosing option as part of combination therapy for patients naive to HIV therapy.”

About the CASTLE Study
The CASTLE study is the first large-scale (n=883), open-label, randomized study designed to demonstrate the non-inferiority of REYATAZ/r to lopinavir/r in treatment-naive HIV-1 infected adult patients. Forty-eight week data from the study were presented earlier this year at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Mass., and previously announced in a press release on February 6, 2008. Data from the CASTLE study were also published in the August 23 issue of The Lancet.

Source: Bristol-Myers Squibb Company

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