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
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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.
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Its superiority has been demonstrated compared to no treatment in terms of HBe seroconversion at 24 weeks after 48 weeks of treatment.
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Despite its safety, it can lead to a sustained virological response (HBs seroconversion) and does not induce resistance.
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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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