The Food and Drug Administration has approved a new low-dose Kaletra (lopinavir/ritonavir) tablet, sold as Aluvia in many other parts of the world, for use in HIV-positive children, according to the drug’s maker, Abbott.
As reported at the 11th European AIDS Conference in Madrid in October, Abbott has demonstrated that the new Kaletra tablets produce blood levels equivalent to the standard adult dose Kaletra. Abbott has also worked out dosing recommendations appropriate for children regardless of age or body size.
For children who can swallow pills, the new tablets can be used in place of the liquid formulation of Kaletra, which contains alcohol and, according to many HIV-positive children, has a bad taste. The new tablet formulation is also expected to have fewer digestive side effects like nausea and diarrhea.
The new tablets, containing 100mg lopinavir and 25mg ritonavir, will be available in the United States this month. Abbott is awaiting approval for the lower-strength tablets in Europe and to register the new formulation in more than 150 countries.
