The European Medicines Agency has approved once-daily dosing of the protease inhibitor Kaletra (lopinavir/ritonavir) in patients new to HIV treatment, manufacturer Abbott Laboratories announced this week.
According to a company press release, Kaletra dosed once daily might be associated with a lesser sustainability of virologic suppression and a higher risk of diarrhoea compared to the recommended standard twice-daily dosage. Kaletra once-daily dosing is not validated in antiretroviral-experienced patients and has not been evaluated in paediatric patients. Kaletra must not be administered once daily in combination with efavirenz, nevirapine, nelfinavir, amprenavir, carbamazepine, phenobarbital or phenytoin.
Although the European Medicines Agency has only approved once-daily dosing in treatment-naive patients, results from a recently reported randomised study showed that in treatment-experienced patients there was no significant difference in viral load suppression or side-effects during 48 weeks of follow-up between patients who took the drug once or twice daily.