Chronic hepatitis C

Indication for Interferon, alfa-2b

Population group: Suitable for both men and women, only adults (18 - 65 years old)

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

3 million IU once every other day

Route of admnistration

Subcutaneous

Defined daily dose

3,000,000 - 3,000,000 [iU]

Dosage regimen

From 3,000,000 To 3,000,000 [iU] once every 2 day(s)

Detailed description

Interferon alpha-2b is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.

Relapse patients (adults)

Interferon alpha-2b is given in combination with ribavirin. Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with interferon alpha-2b in combination with ribavirin for 6 months.

The efficacy of interferon alpha-2b is enhanced when given in combination with ribavirin. Interferon alpha-2b should be given alone mainly in case of intolerance or contraindication to ribavirin.

Interferon alpha-2b in combination with ribavirin

Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with interferon alpha-2b in combination with ribavirin for at least 6 months.

Treatment should be continued for another 6-month period (i.e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.

Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.

During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCV- RNA below lower limit of detection six months after withdrawal of treatment).

Interferon alpha-2b alone

The optimal duration of therapy with interferon alpha-2b alone is not yet fully established, but a therapy of between 12 and 18 months is advised.

It is recommended that patients be treated with interferon alpha-2b alone for at least 3 to 4 months, at which point HCV-RNA status should be determined. Treatment should be continued in patients who exhibit negative HCV-RNA.

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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