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Peginterferon alfa-2b

Generic Name
Peginterferon alfa-2b
Brand Names
Pegintron, Sylatron
Drug Type
Biotech
CAS Number
215647-85-1
Unique Ingredient Identifier
G8RGG88B68

Overview

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 . 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 . Peginterferon alfa-2b was used alongside Ribavirin(https://go.drugbank.com/drugs/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 . 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 . 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.

Indication

Peginterferon alfa-2b is indicated for the treatment of HCV in combination with Ribavirin and a NS3/4A protease inhibitor for genotype 1 or without a NS3/4A protease inhibitor for genotypes 2-6 . May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies. It is also indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy.

Associated Conditions

  • Chronic Hepatitis C Virus (HCV) Infection
  • Melanoma

Research Report

Published: Jul 21, 2025

Peginterferon Alfa-2b: A Comprehensive Clinical and Pharmacological Review

Executive Summary

Peginterferon alfa-2b is a biological therapeutic agent belonging to the cytokine class of drugs, specifically a pegylated form of recombinant human interferon alfa-2b.[1] Its development represented a significant pharmacokinetic advance over standard interferon, achieved by covalently conjugating the protein to a 12,000-dalton linear polyethylene glycol (PEG) moiety. This modification substantially prolongs the drug's elimination half-life, permitting a more convenient once-weekly subcutaneous dosing regimen.[3] The drug exerts pleiotropic antiviral, antiproliferative, and immunomodulatory effects by binding to the type I interferon receptor and activating the Janus Kinase/Signal Transducer and Activator of Transcription (JAK/STAT) signaling pathway, leading to the expression of hundreds of interferon-stimulated genes.[1]

Peginterferon alfa-2b has received U.S. Food and Drug Administration (FDA) approval for two distinct indications under separate brand names to mitigate the risk of prescribing errors. As PEG-Intron, it is indicated for the treatment of chronic hepatitis C (CHC), typically in combination with ribavirin and, historically, with direct-acting antiviral agents.[1] As

Sylatron, it is indicated for the adjuvant treatment of malignant melanoma with nodal involvement following surgical resection.[8] The drug also sees significant off-label use in the management of myeloproliferative neoplasms (MPNs) such as polycythemia vera and essential thrombocythemia, where its unique mechanism offers the potential for disease modification.[11]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/08/14
N/A
Recruiting
Guangzhou 8th People's Hospital
2022/01/10
Phase 4
Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
2021/04/15
Phase 3
Completed
2019/04/19
Not Applicable
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
2019/04/18
Not Applicable
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
2017/06/08
N/A
Completed
2016/12/05
Phase 2
Terminated
Aiwu Ruth He, MD
2016/11/25
Phase 4
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
2015/11/16
Not Applicable
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
2015/03/04
Phase 1
Completed
Inge Marie Svane

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PEGETRON
Merck Canada Inc
02246026
Capsule ,  Powder For Solution - Subcutaneous ,  Oral
50 MCG / 0.5 ML
8/13/2002
PEGETRON
Merck Canada Inc
02246027
Powder For Solution ,  Capsule - Subcutaneous ,  Oral
80 MCG / 0.5 ML
8/13/2002
VICTRELIS TRIPLE
Merck Canada Inc
02371472
Capsule ,  Powder For Solution - Oral ,  Subcutaneous
150 MCG / 0.5 ML
8/16/2011
VICTRELIS TRIPLE
Merck Canada Inc
02371448
Capsule ,  Powder For Solution - Subcutaneous ,  Oral
80 MCG / 0.5 ML
8/16/2011
UNITRON PEG
Merck Canada Inc
02242966
Powder For Solution - Subcutaneous
74 MCG / VIAL
3/27/2001
UNITRON PEG
Merck Canada Inc
02242967
Powder For Solution - Subcutaneous
118.4 MCG / VIAL
3/27/2001
UNITRON PEG
Merck Canada Inc
02242969
Powder For Solution - Subcutaneous
222 MCG / VIAL
3/27/2001
PEGETRON
Merck Canada Inc
02246030
Powder For Solution ,  Capsule - Subcutaneous ,  Oral
150 MCG / 0.5 ML
8/13/2002
PEGETRON
Merck Canada Inc
02246028
Capsule ,  Powder For Solution - Oral ,  Subcutaneous
100 MCG / 0.5 ML
8/13/2002
PEGETRON
Merck Canada Inc
02254638
Capsule ,  Powder For Solution - Subcutaneous ,  Oral
120 MCG / 0.5 ML
9/17/2004

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
PEGINTRON 50 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
00131002
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
ViraferonPeg 80 microgramos polvo y disolvente para solucion inyectable en pluma precargada
00132035
POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PEGINTRON 80 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
00131035
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PEGINTRON 50 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
100131032
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PEGINTRON 50 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
00131031
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PEGINTRON 120 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
100131044
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PEGINTRON 100 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
00131039
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PEGINTRON 80 microgramos POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
100131036
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
ViraferonPeg 100 microgramos polvo y disolvente para solucion inyectable en pluma precargada
00132039
POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
ViraferonPeg 150 microgramos polvo y disolvente para solucion inyectable en pluma precargada
00132047
POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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