terça-feira, maio 03, 2005

Kaletra uma vez ao dia aprovado pela FDA para naives

FDA today approved the use of KALETRA 800/200 mg once-daily administration for the treatment of HIV-infection in therapy-naive adult patients, based on review and analysis of two clinical trials comparing safety and efficacy of lopinavir (LPV)/ritonavir (RTV) 800/200 mg once daily (qd) and LPV/RTV 400/100 mg twice daily (bid), for a duration of at least 48 weeks in antiretroviral-naive HIV-1 infected subjects.

At this time, once daily Kaletra is not approved for treatment experienced patients because trough concentrations of lopinavir are approximately 60% than that observed in the twice daily regimen and because there are no clinical studies comparing the two dosing schedules in treatment-experienced individuals.

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