Abbott announced that the FDA has approved once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced adult patients with HIV. This approval is supported by data from the M06-802 study, a 48-week, Phase 3, open-label, randomized study comparing once-daily to twice-daily dosing of Kaletra combined with other antiretrovirals in 599 treatment-experienced HIV-infected adults. The data showed comparable efficacy, safety and tolerability between once-daily and twice-daily dosing, as well as a similar rate of resistance development between the regimens.

Kaletra once-daily dosing is already indicated for adult patients new to antiretroviral treatment.

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