Abbott announced that the US Food and Drug Administration (FDA) approved once-daily dosing of Kaletra (lopinavir/ritonavir) for adult patients with HIV who have previously taken antiretroviral therapy. 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.
"Adherence to treatment is critical to the effective management of HIV," said Joseph Gathe, clinical instructor, Department of Internal Medicine, Baylor College of Medicine. "A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients."
Kaletra tablets can be taken with or without food and can be stored at room temperature, making it convenient for patients.
Approval of once-daily Kaletra for treatment-experienced patients comes as Abbott marks the 10th anniversary of the medication's original US FDA approval for the treatment of HIV. The US FDA granted early access approval on Sept.15, 2000. Kaletra and other protease inhibitors have become critical components of HIV combination therapy used to help patients manage HIV. Many innovations in HIV treatment have occurred during the past decade, giving physicians and patients more treatment options.
"For more than a decade, HIV treatment was about helping people live another day, another week, another month. Now it is also about making treatment more convenient for patients," said Scott C Brun, divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "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."
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, randomized 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.
The HIV virus can change over time and HIV resistance is the consequence of mutations that emerge in the viral proteins targeted by antiretroviral agents. The use of Kaletra once-daily should be limited to those adult patients having only very few protease inhibitor associated mutations (i.e., less than three lopinavir mutations).