Abbott announced has received marketing authorization from the European Commission for once-daily dosing of the Kaletra (lopinavir/ritonavir) tablet, the company's leading HIV protease inhibitor (PI), in adult patients new to HIV therapy. The Kaletra tablet is now approved for once-daily as well as twice-daily use in this patient population in combination with other anti-retroviral agents, giving physicians another option when deciding on the most appropriate HIV dosing regimen.
"The approval of this new dosing option for Kaletra in Europe is valuable for adult patients who may benefit from being able to take their prescribed Kaletra regimen one time each day," said Scott Brun, divisional vice president, Infectious Disease Development, Global Pharmaceutical Research and Development, Abbott. "Once-daily dosing of a co-formulated tablet, such as Kaletra, is especially important for patients whose life circumstances present challenges to treatment compliance."
The new dosing indication is available in cases where once-daily Kaletra administration is considered necessary for the management of the patient. 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 anti-retroviral 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.
The Kaletra tablet can be taken with or without food and does not require refrigeration - two important advances in delivering HIV medicine.
"With the management of HIV, it is important to consider the needs of each patient," said Juan González-García, Hospital Universitario La Paz, Madrid, Spain. "New treatment options, such as once-daily dosing of Kaletra, have increased the interest of physicians and patients in identifying treatments that can be tailored to a patient's lifestyle rather than a patient adapting his or her lifestyle to the treatment."
Kaletra is an inhibitor of human immunodeficiency virus (HIV) protease enzyme used for the treatment of HIV-1 infected adults and children above the age of two years.