December 21, 2011 — The US Food and Drug Administration (FDA) today expanded the indication of the HIV drug raltegravir (Isentress, Merck) beyond adults to include children and adolescents from 2 to 18 years of age.
The approval follows a multicenter clinical trial of 96 children and adolescents who had previously received treatment for HIV infection. After 24 weeks of raltegravir therapy, roughly half the patients had undetectable blood levels of HIV.
"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
Raltegravir belongs to a drug class called HIV integrase strand transfer inhibitors that slow the spread of HIV in the body. The FDA originally approved it for adult patients in October 2007 under the administration's accelerated approval program, designed to provide patients with earlier access to promising new drugs. In this program, manufacturers must submit additional clinical information after approval to confirm the drug's benefit.
Raltegravir, a tablet, can be taken twice a day either with or without food. There are 2 chewable versions — a 25-mg tablet and a 100-mg scored tablet — approved only for use in children aged 2 to 11 years.
The FDA-approved dose is a 400-mg film-coated tablet twice a day for adolescents aged 12 years and older. Children aged 6 to 11 years who weigh at least 25 kg can take the 400-mg film-coated tablet twice daily or chewable tablets in weight-based doses up to 300 mg, twice daily.
Children aged 6 to 11 years who weigh less than 25 kg should receive only chewable tablets weight-based up to 300 mg, twice daily, as should children aged 2 to 5 years who weigh at least 10 kg.
The FDA states that because the formulations are not bioequivalent, the chewable tablets should not be substituted for the 400- mg film-coated tablet.
Severe adverse events that are most commonly reported for raltegravir are insomnia and headache, and children and adults experience them at equal rates. The agency advises clinicians to discontinue raltegravir if patients develop a treatment-related skin rash or severe insomnia.
More information about today's FDA announcement is available on the agency's Web site.
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Cite this: HIV Drug Raltegravir Approved for Children, Adolescents - Medscape - Dec 21, 2011.