The FDA announced in late April the approval of once-daily 800/200 mg lopinavir/ritonavir (Kaletra) tablets and oral solution for use by previously treated HIV positive adults without extensive lopinavir resistance. Once-daily administration is not recommended for children or for adults with three or more lopinavir resistance-associated mutations.
Twice-daily lopinavir/ritonavir was initially approved for treatment-experienced patients in September 2000; once-daily dosing was later added for treatment-naive individuals. The new regimen is supported by data from Study 802, a Phase III randomized clinical trial showing similar efficacy and tolerability with once-daily and twice-daily dosing.View Full Article
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