following an abbreviated submission
entecavir (Baraclude®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of chronic hepatitis B virus infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum alanine aminotransferase levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
SMC restriction: to be prescribed under the supervision of specialists in paediatric infectious diseases.
While the benefits of viral suppression in adults are acknowledged the benefits of anti-viral treatment in children are less well established. In clinical studies, the antiviral efficacy of entecavir in children is reported to be lower than in adults. However there is a potential need for treatment in a very small number of paediatric patients and this is the first licensed medicine for hepatitis B in this age group.
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Medicine details
- Medicine name:
- entecavir (Baraclude)
- SMC ID:
- 1049/15
- Indication:
- Treatment of chronic hepatitis B virus infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum alanine aminotransferase levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Infections
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 11 May 2015