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Approved Hepatitis B Drugs for Children (United States)

Chronic hepatitis B infection is normally a mild disease in children and teens. Most children do not have visible signs or symptoms and can expect to live full, healthy lives without any physical limitations. In rare cases, there are children and teens who may require more immediate medical intervention and treatment.

ALL children and teens with chronic hepatitis B infection should be seen regularly by a pediatric liver specialist (or a provider knowledgeable about hepatitis B) whether they are on treatment or not. The standard recommendation is to schedule visits every six months, but it can be more or less depending on the situation. During these check-ups your child or teen will undergo a physical exam, blood tests, and possible imaging studies of the liver (such as an ultrasound, FibroScan [Transient Elastography] or CT scan).

There are currently 5 approved drugs in the United States for children living with hepatitis B .

  • Entecavir (Baraclude) is a pill that is taken once a day for at least one year or longer. It is considered a first-line treatment.  Approved in 2014 for children 2 years and older.
  • Tenofovir disoproxil (Viread) is a pill that is taken once a day for at least one year or longer. It is considered a first-line treatment. Approved in 2012 for children 12 years and older.
  • Peginterferon alfa-2a (Pegasys) is an injection given once weekly for 6 months to 1 year and may include flu-like symptoms. It is considered a first-line treatment. Children must closely monitored by a liver specialist with regular visits and blood tests.
  • Interferon alpha (Intron A) is an injection usually given three times a week for 6 months to 1 year. Children generally experience fewer side effects than adults, but they can include flu-like symptoms. They must be closely monitored by a liver specialist with regular visits and blood tests. This is an older drug that is not usually prescribed.
  • Lamivudine (Epivir-HBV, Zeffix, Heptodin) is a pill that is taken once a day for at least one year or more. This is an older antiviral that results in drug resistance, thus, considered a second-line treatment.

Not every child with chronic hepatitis B needs to be treated. A pediatric liver specialist (or care provider knowledgeable about hepatitis B) should evaluate your child to decide whether he or she is a good candidate for treatment based on the results of a physical exam, blood tests, and imaging studies such as an ultrasound or CT scan. The approved drugs appear to be of greatest benefit to those who show signs of active liver disease.

Read the Hepatitis B Foundation’s Clinical Guidelines for Pediatric HBV
The Hepatitis B Foundation convened a Pediatric HBV Workshop of the nation’s leading pediatric liver specialists to develop the first national recommendations for the care of children living with chronic hepatitis B infections. These recommendations have been published in highly respected, peer-reviewed journals and provide expert guidance for the care of infected children.

HBF's Pediatric HBV Screening and Monitoring Recommendations  (PDF) Published in Pediatrics in November 2009
Haber BA, Block JM, Jonas MM, Karpen SJ, London WT, McMahon BJ, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB. Recommendations for screening, monitoring, and referral of pediatric chronic hepatitis B. Pediatrics;124:e1007-13. (Nov. 2009)

HBF's Pediatric HBV Management and Treatment Recommendations
(PDF) Published in Hepatology in October 2010
Jonas MM, Block JM, Haber BA, Karpen SJ, London WT, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB, and McMahon BJ (2010). Treatment of children with chronic hepatitis B virus infection in the United States: Patient selection and therapeutic options. Hepatology;52;2192-13. (Oct. 2010)