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news.Abbott has received FDA approval for once-daily dosing of Kaletra (lopinavir / ritonavir) for adult patients with HIV who have previously taken antiretroviral therapy.
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Abbott said that Kaletra once-daily dosing is already indicated for adult patients new to antiretroviral treatment. This gives treatment-experienced patients who have HIV that responds to Kaletra another dosing option as determined by their physician.
Additionally, Kaletra tablets can be taken with or without food and can be stored at room temperature, making it convenient for patients.
Abbott’s submission for once-daily dosing in treatment-experienced patients was supported by data from the M06-802 study, a 48-week, Phase 3, open-label, randomised study comparing once-daily to twice-daily dosing of Kaletra combined with other antiretrovirals in 599 treatment-experienced HIV-infected adults.
The data showed comparable efficacy, safety and tolerability between once-daily and twice-daily dosing, as well as a similar rate of resistance development between the regimens.
Joseph Gathe, clinical instructor of department of internal medicine at Baylor College of Medicine, said: “Adherence to treatment is critical to the effective management of HIV. A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients.”
Scott Brun, divisional vice president of infectious diseases for global pharmaceutical research and development at Abbott, said: “This approval means Kaletra tablets can now be used once or twice daily as part of combination therapy, giving treatment-experienced patients an additional dosing option to better fit their daily schedule.”