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entecavir (Baraclude)

Advice

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.

Drug Details

Drug Name: entecavir (Baraclude)
SMC Drug ID: 1049/15
Manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd
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.
BNF Category:
Sub Category: 5.3 Antiviral Drugs
Submission Type: Abbreviated Submission
Status: Restricted
Date Advice Published: 11 May 2015

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