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FDA expands use of HIV drug Isentress to children, adolescents

(Xinhua)

19:45, December 22, 2011

WASHINGTON, Dec. 21 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved Isentress for the treatment of HIV-1 infection for children and adolescents.

The drug 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 first approved for use in adult patients in October 2007, under FDA's accelerated approval program.

"Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

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

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

According to the FDA, the most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping and headache. The frequency of these side effects is similar for children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash.

 
 
 
 
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