Chronic hepatitis C

Indication for Interferon, alfa-2b

Population group: Suitable for both men and women, only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

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

3 million IU/m² once every other day

Route of admnistration


Defined daily dose

3,000,000 - 3,000,000 [iU] per m² of body surface area (BSA)

Dosage regimen

From 3,000,000 To 3,000,000 [iU] per m² of body surface area (BSA) once every 2 day(s)

Detailed description

Children 3 years of age or older and adolescents

Interferon alpha-2b 3 MIU/m² is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).

The efficacy and safety of interferon alpha-2b in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.

Duration of treatment for children and adolescents

Genotype 1: The recommended duration of treatment is one year. Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%). Therefore, it is recommended that children and adolescent patients receiving interferon 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 2/3: The recommended duration of treatment is 24 weeks.

Active ingredient

Recombinant interferon alfa-2b is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals. It has demonstrated significant immunomodulatory activity in vitro.

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