Isentress Approval Expanded to Include Children and
WEDNESDAY, Dec. 21 (HealthDay News) -- Approval for the HIV drug
Isentress (raltegravir) has been expanded to include children and
adolescents ages 2-18, the U.S. Food and Drug Administration said
The drug is an integrase strand transfer inhibitor that helps
slow the spread of the AIDS-causing virus throughout the body, the
agency said in a news release. It was first approved for adults in
The twice-daily pill is available in a chewable form for people
aged 2 to 11, and in non-chewable form. Clinical testing of the
drug among 96 children and teens with HIV-1 infection showed 53
percent of patients had undetectable blood HIV levels after 24
weeks, the FDA said.
The most common reported side effects of Isentress included
trouble sleeping and headache.
The drug does not cure HIV infection, and patients must take
Isentress continually to ensure ongoing reduction in HIV-related
illness, the FDA stressed.
The drug is produced by Merck & Co., based in Whitehouse
The U.S. Department of Health and Human Services has more about
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