Use of HIV Drug Isentress Expanded to Children and Adolescents

Drug Alerts , News / September 28, 2016

Isentress (raltegravir) has been approved by the FDA for use along with other antiretroviral drugs for the treatment of HIV-1 infection in children and adolescents aged 2-18.

Isentress is part of a class of medications called HIV Integrase Strand Transfer Inhibitors that works by slowing the spread of HIV in the body. It was initially approved for use in adult patients in October 2007, under the FDA’s accelerated approval program.

A single, multi-center clinical trial of 96 children and adolescents ages 2-18 years with HIV-1 infection, who have previously received treatment for the condition, evaluated the safety and effectiveness of Isentress. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.

The most commonly reported severe, treatment-related side effects in patients taking Isentress include insomnia and headache. The frequency of these side effects is similar for both children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash. The drug should be discontinued if this occurs.

Isentress is available in pill form to be taken twice daily, with or without food. The pill is also available in a chewable form. Since the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.

Isentress does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Isentress is made by Whitehouse Station, N.J.-based Merck & Co., Inc.

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