Isentress Gains Expanded Indication for Children with HIV-1

Isentress (raltegravir; Merck) has been approved by the FDA for use with other antiretroviral drugs for the treatment of HIV-1 infection for children 2–18 years, weighing ≥10kg. This approval was based on results from a single, multi-center clinical trial evaluating the safety and efficacy of Isentress in 96 children and adolescents ages 2–18 years with HIV-1 infection who had previously received treatment. After 24 weeks of treatment with Isentress, 53% of these patients had an undetectable amount of HIV in their blood.

Isentress film-coated tablets are already indicated for adults for the treatment of HIV-1 infection, in combination with other antiretrovirals. Isentress will be made available in an additional chewable tablet form in 25mg and 100mg dosage strengths approved for children 2–11 years. The chewable tablet and already available film-coated tablet formulations are not bioequivalent and can not be interchanged.

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