Entecavir approved for children 2 years and older for hepatitis B virus infection

— Christine M. Kukka, Project Manager, HBV Advocate

The U.S. Food and Drug Administration has approved the antiviral entecavir (brand name Baraclude) for use in children and teens age 2 and older. This robust antiviral is the first to be approved by the FDA for children in several years, and is considered one of the top two antivirals available to adults today.

Previously, the only FDA-approved drug treatments for treating children with hepatitis B-related liver damage (including high viral load and signs of liver damage) were considered relatively ineffectively, including conventional interferon that requires a weekly injection (which has been replaced by more effective pegylated interferon for adults) and the antiviral lamivudine (Epivir-HBV), which is considered a substandard because of its high rate of drug resistance.

According to the FDA-approved package insert, children with body weight greater than 30 kg should receive 10 mL (0.5 mg) of oral solution or one 0.5 mg tablet once daily. Children with body weight greater than 30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg tablet once daily. Higher doses of entecavir are recommended  for children who have already developed drug resistance to the antiviral lamivudine,  — Chris

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