FDA approves drug for pediatric HIV

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.

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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.

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