Peginterferon alpha-2b in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.
For this indication, competent medicine agencies globally authorize below treatments:
1.5 - 1.5 ug per kg of body weight
From 1.5 To 1.5 ug per kg of body weight once every 7 day(s)
Peginterferon alpha-2b should be administered as a once weekly subcutaneous injection. The dose administered in adults depends on whether it is used in combination therapy (bitherapy or tritherapy) or as monotherapy.
Bitherapy (peginterferon alpha-2b with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Tritherapy (peginterferon alpha-2b with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Peginterferon alpha-2b 1.5 micrograms/kg/week in combination with ribavirin capsules.
The intended dose of 1.5 μg/kg of peginterferon alpha-2b to be used in combination with ribavirin may be delivered in weight categories with the peginterferon alpha-2b strengths according to Table 1. Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Table 1. Dosing for combination therapy*:
|Body weight (kg)||Peginterferon alpha-2b||Ribavirin capsules|
|Peginterferon alpha-2b strength (μg/0.5 ml)||Administer once weekly (ml)||Total daily ribavirin dose (mg)||Number of capsules (200 mg)|
a 2 morning, 2 evening
b 2 morning, 3 evening
c 3 morning, 3 evening
d 3 morning, 4 evening
* Refer to the SmPC of boceprevir for details about the dose of boceprevir to be administered in tritherapy.
Tritherapy: Refer to the SmPC for boceprevir.
Bitherapy: Predictability of sustained virological response – Patients infected with virus genotype 1 who fail to achieve undetectable HCV-RNA or demonstrate adequate virological response at week 4 or 12 are highly unlikely to become sustained virological responders and should be evaluated for discontinuation.
For patients who exhibit virological response at week 12, treatment should be continued for at least another three-month period (i.e., a total of six months). The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age >40 years, male gender, bridging fibrosis).
If severe adverse reactions or laboratory abnormalities develop during treatment with peginterferon alpha-2b monotherapy or combination therapy, the dosages of peginterferon alpha-2b and/or ribavirin must be modified as appropriate, until the adverse reactions abate. Dose reduction of boceprevir is not recommended. Boceprevir must not be administered in the absence of peginterferon alpha-2b and ribavirin. As adherence might be of importance for outcome of therapy, the dose of peginterferon alpha-2b and ribavirin should be kept as close as possible to the recommended standard dose.
Guidelines were developed in clinical trials for dose modification.