In early May, the FDA approved once-daily dosing of Abbott’s powerhouse protease inhibitor (PI) Kaletra (lopinavir plus booster ritonavir)—but only for folks new to HIV meds. For now, the rest of you are stuck with the twice-a-day: Once-daily hasn’t been tested in old-timers, and some HIV docs and treatment advocates worry that the PI’s blood levels will fall too low over 24 hours to work in folks with resistant virus. And once-daily dosing comes with a caution as big and bold as Kaletra’s famously bright-orange capsule: The incidence of diarrhea may rise if you take Kaletra all at once rather than in two daily doses. Still, one dose is one less to worry about. And Abbott is reformulating the soft-gel capsule into a tablet, hoping that the new tab will table Kaletra’s gastro side effects. The tablet will reduce the daily pill total from six to four and may avoid the PI’s take-with-food restriction (it’s being tested with and without). What’s more, it will omit one ingredient—fatty oleic acid—which Abbott’s George Hanna, MD, fingers for the diarrhea and nausea. The new tabs are being tested in HIVers new and old to meds. Last but not least, Abbott foresees a Norvir (ritonavir) remix, so HIVers who use Norvir to boost other PIs may be able to kick those icky side effects, too.
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New Kaletra, Nice to Meet Ya
July 1, 2005
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