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FDA reviewing safety of HIV drug combination

February 24, 2010 1:10 AM UTC

FDA issued an early communication about an ongoing safety review of HIV drug Invirase saquinavir from Roche (SIX:ROG; OTCQX:RHHBY) boosted with Norvir ritonavir from Abbott Laboratories (NYSE:ABT). The agency said preliminary data from a QT study of the combination in healthy volunteers showed a dose-dependent prolongation of the QT and PR intervals, which could lead to torsades de pointe -- a frequently fatal arrhythmia -- and heart block, respectively. Roche submitted the data after FDA requested that all manufacturers of protease inhibitors conduct a QT study. ...