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FDA approves Abbott’s once-daily HIV drug

Abbott has received FDA approval to market a new, once-daily dosing regimen for Kaletra, a protease inhibitor used in combination with other anti-HIV medications for the initial treatment of HIV.

The new dosing regimen for Kaletra (lopinavir/ritonavir) is available in both liquid and soft gel capsule formulations and offers physicians and patients increased flexibility in managing their HIV treatment.

Approval for the new regimen is based on data from a clinical study conducted in 190 patients new to HIV therapy which evaluated the effectiveness of once-daily and twice-daily Kaletra doses, both administered in combination with once-daily tenofovir and emtricitabine, over a period of 48 weeks. Results demonstrated comparable virologic responses between the once- and twice-daily dosing groups.

“We are pleased to be able to provide patients with a once-daily, Kaletra-based regimen, as an alternative that provides comparable efficacy to the twice-daily dosing option in initial treatment of HIV,” said Dr Scott Brun, divisional vice president of infectious disease development at Abbott. “The once-daily regimen provides enhanced flexibility for people living with HIV.”