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PEGASYS (peginterferon alfa-2a), interferon

INFECTIOUS DISEASE - New indication
Opinions on drugs - Posted on Nov 28 2018

Reason for request

Extension of indication

High clinical benefit in chronic hepatitis B in children over the age of 3 and minor clinical added value like VIREAD and BARACLUDE

 

  • PEGASYS has now a marketing authorization (MA) in the treatment of HBe antigen (HBeAg)-positive chronic hepatitis B in non-cirrhotic children and adolescents aged 3 years and over, with viral replication and confirmed persistently elevated serum ALAT levels.

  • Its superiority has been demonstrated compared to no treatment in terms of HBe seroconversion at 24 weeks after 48 weeks of treatment.

  • Despite its safety, it can lead to a sustained virological response (HBs seroconversion) and does not induce resistance.

  • It should be started on a case by case basis, taking predictive factors of response to interferon into account along with the risk of adverse effects.

 

 


Actual benefit

Important

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Improvement in actual benefit

IV (mineur)

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