Chronic hepatitis C

Active Ingredient: Peginterferon alpha-2b

Indication for Peginterferon alpha-2b

Population group: only children (1 year - 12 years old)

Peginterferon alpha-2b is indicated in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA.

When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case by case basis.

For this indication, competent medicine agencies globally authorize below treatments:

60 μg/m² once a week

Route of admnistration

Subcutaneous

Defined daily dose

60 - 60 ug per m² of body surface area (BSA)

Dosage regimen

From 60 To 60 ug per m² of body surface area (BSA) once every 7 day(s)

Detailed description

Paediatric population (bitherapy only) – Dose to be administered

Dosing for children 3 years of age and older and adolescent patients is determined by body surface area for peginterferon alpha-2b and by body weight for ribavirin. The recommended dose of peginterferon alpha-2b is 60 μg/m²/week subcutaneously in combination with ribavirin 15 mg/kg/day orally in two divided doses with food (morning and evening).

Paediatric population (bitherapy only) - Duration of treatment

  • Genotype 1: The recommended duration of treatment with bitherapy is 1 year. By extrapolation from clinical data on combination therapy with standard interferon in paediatric patients (negative predictive value 96% for interferon alfa–2b/ribavirin), patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders. Therefore, it is recommended that children and adolescent patients receiving peginterferon alpha-2b/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped <2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
  • Genotype 2 or 3: The recommended duration of treatment with bitherapy is 24 weeks.
  • Genotype 4: Only 5 children and adolescents with Genotype 4 were treated in the peginterferon alpha-2b/ribavirin clinical trial. The recommended duration of treatment with bitherapy is 1 year. It is recommended that children and adolescent patients receiving peginterferon alpha-2b/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped <2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.

Active ingredient

Peginterferon alpha-2b

Peginterferon alpha-2b is a covalent conjugate of recombinant interferon alfa-2b with monomethoxy polyethylene glycol. Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism. This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.

Read more about Peginterferon alpha-2b

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