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Once-Daily Lopinavir/Ritonavir Tablet Approved in EU for Treatment-Naïve HIV Patients NEW YORK -- September 14, 2009 -- The European Commission has approved the once daily dosing combination tablet of lopinavir/ritonavir (Kaletra) for the treatment of patients with HIV who are treatment-naïve. The new dosing indication is available in cases where once-daily lopinavir/ritonavir administration is considered necessary for the management of the patient. The once daily dose might be associated with a lesser sustainability of virologic suppression and a higher risk of diarrhoea compared with the recommended standard twice-daily dosage. Lopinavir/ritonavir once-daily dosing is not validated in antiretroviral-experienced patients and has not been evaluated in paediatric patients. Lopinavir/ritonavir must not be administered once daily in combination with efavirenz, nevirapine, nelfinavir, amprenavir, carbamazepine, phenobarbital or phenytoin. In clinical trials, the most common side effects of moderate to severe intensity were diarrhoea, insomnia, headache, burning or prickling sensation around the mouth and extremities, nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder, rash, lipodystrophy, acne, and weakness. This is not a complete list of reported side effects. SOURCE: Abbott E-mail this page to a friend or colleague! To print, use this version