Active Ingredient: Interferon, alfa-2b
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
3,000,000 - 3,000,000 [iU]
From 3,000,000 To 3,000,000 [iU] once every 2 day(s)
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.
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.
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).
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.
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