| Pharmaceutical Information |
| Drug Name |
Peginterferon alfa-2b |
| Drug ID |
BADD_D01696 |
| Description |
Peginterferon alfa-2b is a form of recombinant interferon used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients [L852]. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) resulting in less use of Peginterferon alfa-2b. Peginterferon alfa-2b is derived from the alfa-2b moeity of recombinant human interferon and acts by binding to human type 1 interferon receptors. Activation and dimerization of this receptor induces the body's innate antiviral response by activating the janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway. Use of Peginterferon alfa-2b is associated with a wide range of severe adverse effects including the aggravation and development of endocrine and autoimmune disorders, retinopathies, cardiovascular and neuropsychiatric complications, and increased risk of hepatic decompensation in patients with cirrhosis. The use of Peginterferon alfa-2b has largely declined since newer interferon-free antiviral therapies have been developed.
In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) no longer recommend Peginterferon alfa-2b for the treatment of Hepatitis C [A19593]. Peginterferon alfa-2b was used alongside [DB00811] with the intent to cure, or achieve a sustained virologic response (SVR), after 48 weeks of therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality [A19626].
Peginterferon alfa-2b is available as a variable dose injectable product (tradename Pegintron) used for the treatment of chronic Hepatitis C. Approved in 2001 by the FDA, Pegintron is indicated for the treatment of HCV with [Ribavirin] or other antiviral drugs [FDA Label]. When combined together, Peginterferon alfa-2b and [Ribavirin] have been shown to achieve a SVR between 41% for genotype 1 and 75% for genotypes 2-6 after 48 weeks of treatment. |
| Indications and Usage |
Peginterferon alfa-2b is indicated for the treatment of HCV in combination with [DB00811] and a NS3/4A protease inhibitor for genotype 1 or without a NS3/4A protease inhibitor for genotypes 2-6 [FDA Label]. May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
|
| Marketing Status |
approved |
| ATC Code |
L03AB10 |
| DrugBank ID |
DB00022
|
| KEGG ID |
D02748
|
| MeSH ID |
C417083
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D08NWC
|
| NDC Product Code |
Not Available |
| UNII |
G8RGG88B68
|
| Synonyms |
peginterferon alfa-2b | PEG-IFNalpha-2b | PEG INF alfa-2b | PEG INF alpha-2b | polyethylene glycol-interferon alfa-2b | pegylated interferon alfa-2b | peg-proline-interferon alpha-2b | peg-proline-INFalpha-2b | Pegintron | ViraferonPeg | PEG-Intron |
|
| Chemical Information |
| Molecular Formula |
Not Available |
| CAS Registry Number |
215647-85-1 |
| SMILES |
Not Available |
| Chemical Structure |
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| ADRs Induced by Drug |
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