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Bristol-Myers Squibb’s HIV combination therapy wins FDA approval

Bristol-Myers Squibb Company has announced that the FDA has approved the use of Reyataz 300mg once-daily boosted with ritonavir 100mg as part of combination therapy in previously untreated HIV-1 infected patients.

This use of once-daily Reyataz boosted with ritonavir (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, each as part of HIV combination therapy, in treatment-naive HIV-1 infected adult patients.

Reyataz/r taken once daily with food is recognized by the US 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 400mg (without ritonavir), taken once daily with food, is recommended.

Elliott Sigal, executive vice president, chief scientific officer and president of R&D at Bristol-Myers Squibb, said: “Bristol-Myers Squibb is committed to developing medicines that enhance the care of people living with HIV and AIDS. Boosted Reyataz provides healthcare professionals a newly approved, once-daily dosing option as part of combination therapy for patients naive to HIV therapy.”