FDA Approves Once-Daily Combination of Abbott’s Protease Inhibitor Kaletra
Pharmaceutical company Abbott Laboratories on Monday announced that FDA has approved a once-daily formulation of its antiretroviral protease inhibitor Kaletra, which is used in combination with other drugs for initial treatment of HIV, Dow Jones/SmartMoney.com reports (Rojas, Dow Jones/SmartMoney.com, 5/2). Protease inhibitors work by blocking the action of an enzyme that cuts HIV proteins into the shorter sections that the virus needs to replicate (Kaiser Daily HIV/AIDS Report, 2/28). The once-daily Kaletra -- which is a combination of the antiretroviral drugs lopinavir and ritonavir and initially was approved in a twice-daily regimen -- will be available in liquid and soft-gel formulations. According to Abbott, Kaletra is the most-prescribed protease inhibitor in the United States, Dow Jones/SmartMoney.com reports. FDA approval was based on data from a clinical study of 190 patients new to HIV therapy that compared once-daily and twice-daily Kaletra doses, both administered in combination with once-daily tenofovir and emtricitabine over a 48-week period (Dow Jones/SmartMoney.com, 5/2). The results of the trial showed comparable HIV viral loads of less than 50 copies per milliliter on average between the two dosing groups, according to an Abbott release. Side effects of both regimens included nausea and diarrhea, including more frequent diarrhea for the once-daily group. However, the once-daily regimen was "generally well-tolerated," according to the release. Scott Brun, Abbott divisional vice president for infectious disease development, said the once-daily regimen will provide "enhanced flexibility for people living with HIV" (Abbott release, 5/2).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.