Indications : התוויות

4.1   Therapeutic indications

Tritherapy:
Rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis C (CHC) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.
Please refer to peginterferon alfa -2b and boceprevir Summary of Product Characteristics (SmPCs) when using Rebetol in combination with these medicines.

Bitherapy:
Rebetol is indicated for the treatment of chronic hepatitis C virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Rebetol monotherapy must not be used.
Please refer to interferon alfa-2b and peginterferon alfa-2b Summary of Product Characteristics (SmPCs) when using Rebetol in combination with these medicines.

There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).

Previously untreated (naïve) patients
Adult patients (18 years of age or older): Rebetol is indicated for:
• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis C genotype1 infection with compensated liver disease • bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA).
• bitherapy- for the treatment of CHC infection in combination with peginterferon alfa-2b for patients with compensated cirrhosis and/or clinically stable HIV co-infection (see section        4.4).

Previously treated patients
Adult patients: Rebetol is indicated for:
• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients having CHC genotype 1 infection with compensated liver disease.


•    bitherapy- in combination with peginterferon alfa-2b, for the treatment of patients with chronic hepatitis C who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin (see section5.1).
•    bitherapy-in combination with interferon alfa-2b, for the treatment of patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed.