Peginterferon alpha-2b

Therapeutic indications

Peginterferon alpha-2b is indicated for:

Chronic hepatitis C (CHC) genotype 1

Population group: only adults (18 - 65 years old)

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 (click for details):

Chronic hepatitis C positive for hepatitis C virus RNA (HCV-RNA)

Population group: only adults (18 years old or older)

Peginterferon alpha-2b is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.

Peginterferon alpha-2b in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy.

Interferon monotherapy, including peginterferon alpha-2b, is indicated mainly in case of intolerance or contraindication to ribavirin.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Chronic hepatitis C

Population group: only children (1 year - 12 years old)

Peginterferon alpha-2b is indicated in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA.

When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case by case basis.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Peginterferon alpha-2b is contraindicated in the following cases:

Cardiac disease

Heart disease

Autoimmune hepatitis, autoimmune disease

Autoimmune disease

Severe hepatic dysfunction, decompensated cirrhosis of the liver

at least one of
Hepatic failure stage IV
Decompensated cirrhosis of liver

Thyroid disease

Disorder of thyroid gland

Epilepsy, compromised central nervous system (CNS) function

at least one of
Epilepsy
Abnormal nervous system function

HCV/HIV patients with cirrhosis

at least one of
Type B viral hepatitis
Human immunodeficiency virus infection
and additionally Cirrhosis of liver

Telbivudine

Telbivudine

Severe psychiatric conditions

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Mental disorder

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Summary of Product Characteristics (SPC) 2018: PEGINTRON Powder and solvent for solution for injection
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