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
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]
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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