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.
Clinical Benefit
Substantial |
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Clinical Added Value
minor |
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