The FDA approved today
a drug for use as treatment for HIV-1 infection in children and adolescents.
The agency approved raltegravir (Isentress, Merck) for
use with other antiretroviral drugs for the treatment of HIV-1 infection for
children and adolescents aged 2 to 18 years, according to an FDA press release.
The drug is an HIV integrase strand-transfer inhibitor
that works by slowing the spread of HIV in the body. Raltegravir was first
approved in October 2007 for use in adult patients.
Isentress is available in tablet form and can be taken
twice daily, with or without food. The tablet is also available in a chewable
form. Because the two tablet formulations are not interchangeable, the chewable
form is approved only for use in children aged 2 to 11 years.
A single, multicenter clinical trial of 96 children and
adolescents aged 2 to 18 years with HIV-1 infection evaluated the safety and
effectiveness of raltegravir. These patients previously received treatment for
HIV-1 infection. After 24 weeks of treatment with raltegravir, 53% had an
undetectable viral load.
Insomnia and headache were the most commonly reported
severe adverse events related to raltegravir. The frequency of these adverse
effects is similar for children and adults. One pediatric patient reported
severe treatment-related insomnia, and another pediatric patient experienced a
drug-related skin rash. The drug should be discontinued if this occurs.