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BARACLUDE, (entecavir), antiviral for hepatitis B

INFCTIOUS DISEASES - Update
Opinions on drugs - Posted on Nov 03 2016

Reason for request

Extension of indication

Minor improvement in the treatment of children aged from 2 to 18 years

  • BARACLUDE now has Marketing Authorisation in the treatment of chronic hepatitis B virus (HBV) infections in nucleoside-treatment-naïve patients aged from 2 years to under 18 years, presenting compensated liver disease with evidence of active viral replication and persistently elevated serum ALAT levels, or histological evidence of moderate to severe hepatic inflammation and/or fibrosis.
  • Like VIREAD, it represents a minor improvement in the treatment of these children.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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