Kaletra Tablets Offer Convenience Benefits, Abbott Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm plans to transition all patients on Kaletra (lopinavir/ritonavir) capsules to the new tablet formulation, which reduces the pill count and eliminates the need for refrigeration.
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Abbott is highlighting convenience benefits with a newly approved tablet formulation of its HIV therapy Kaletra (lopinavir/ritonavir). Patients will have to take fewer pills and have the option of taking the pills with or without food with the new tablet formulation. In addition to reducing the number of pills per day, the tablet formulation does not have a refrigeration requirement. FDA approved the new formulation Oct. 28. Instead of taking six pills a day with the original capsule formulation, patients' pill burden will be reduced to four tablets per day. "The standard daily doses of new Kaletra tablets and capsules provide similar drug levels in the blood," Abbott noted. Approval of Kaletra tablets was based on pharmacokinetic studies in 141 non-HIV infected healthy volunteers. The tablets use Meltrex melt-extrusion technology, which enables "stable, solid dispersion of Kaletra within a tablet that provides similar drug levels in the blood relative to the capsules." The new film-coated tablets are yellow and contain 200 mg lopinavir and 50 mg ritonavir; the old capsules are orange and contain 133.3 mg lopinavir and 33.3 mg ritonavir. Abbott intends to transition all Kaletra patients from capsules to tablets "to reduce the potential for patients and pharmacist confusion between the two formulations." The company plans to have a full conversion completed by March 2006. "Kaletra tablets will be available at pharmacies across the country in the next few weeks," Abbott said. Abbott received approval for a once-daily regimen of Kaletra in April, allowing for six pills to be taken once a day instead of three pills twice daily (1 (Also see "Abbott's HIV Therapy Kaletra Gets Once-Daily Dosing" - Pink Sheet, 29 Apr, 2005.)). Kaletra is the top prescribed protease inhibitor for treatment of HIV worldwide, Abbott reported. The firm also cited guidelines issued by an HHS panel in October that recommend Kaletra in combination with zidovudine and lamivudine or emtricitabine as the preferred PI regimen for treatment-naive patients. -Mary Jo Laffler |