MedPath

Peginterferon alfa-2a

Generic Name
Peginterferon alfa-2a
Brand Names
Pegasys
Drug Type
Biotech
CAS Number
198153-51-4
Unique Ingredient Identifier
Q46947FE7K

Overview

Peginterferon alfa-2a 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-2a. Peginterferon alfa-2a is derived from the alfa-2a 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-2a 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-2a 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-2a for the treatment of Hepatitis C . Peginterferon alfa-2a was used alongside Ribavirin 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-2a is available as a fixed dose injector (tradename Pegasys) used for the treatment of chronic Hepatitis C. Approved in 2002 by the FDA, Pegasys is indicated for the treatment of HCV with Ribavirin or other antiviral drugs . When combined together, Peginterferon alfa-2a and Ribavirin have been shown to achieve a SVR between 36% for genotype 1 and 59% for genotypes 2-6 after 48 weeks of treatment.

Background

Peginterferon alfa-2a 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-2a. Peginterferon alfa-2a is derived from the alfa-2a 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-2a 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-2a 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-2a for the treatment of Hepatitis C . Peginterferon alfa-2a was used alongside Ribavirin 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-2a is available as a fixed dose injector (tradename Pegasys) used for the treatment of chronic Hepatitis C. Approved in 2002 by the FDA, Pegasys is indicated for the treatment of HCV with Ribavirin or other antiviral drugs . When combined together, Peginterferon alfa-2a and Ribavirin have been shown to achieve a SVR between 36% for genotype 1 and 59% for genotypes 2-6 after 48 weeks of treatment.

Indication

Peginterferon alfa-2a is indicated for the treatment of HCV in combination with other antiviral drugs in patients over 5 years of age with compensated liver disease . May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies. Peginterferon alfa-2a is also indicated as a monotherapy for adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation .

Associated Conditions

  • Chronic Hepatitis B Infection
  • Chronic Hepatitis C Virus (HCV) Infection
  • HBeAg Positive Chronic Hepatitis B

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/10
Phase 4
Completed
2025/02/14
Not Applicable
Recruiting
Children's Hospital of Soochow University
2023/11/22
Phase 1
Terminated
2023/07/20
Phase 2
Withdrawn
2023/02/15
Phase 1
Withdrawn
Baptist Health South Florida
2021/11/22
Phase 1
Completed
PharmaEssentia
2021/03/15
Phase 2
Recruiting
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
2018/03/29
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
pharmaand GmbH
82154-0449
SUBCUTANEOUS
180 ug in 1 mL
2/16/2024
pharmaand GmbH
82154-0451
SUBCUTANEOUS
180 ug in 0.5 mL
2/16/2024
Genentech, Inc.
0004-0350
SUBCUTANEOUS
180 ug in 1 mL
11/8/2019
Genentech, Inc.
0004-0357
SUBCUTANEOUS
180 ug in 0.5 mL
11/8/2019

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
6/20/2002

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
PEGASYS PRE-FILLED SYRINGE FOR INJECTION 180 mcg/0.5 ml
SIN12313P
INJECTION
180 mcg/0.5 ml
6/5/2003
PEGASYS PRE-FILLED SYRINGE FOR INJECTION 135 mcg/0.5 ml
SIN12314P
INJECTION
135 mcg/0.5 ml
6/5/2003

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Recombinant Human Interferon α2a Cream
国药准字S20153008
N/A
软膏剂
6/11/2020
Recombinant Human Interferon α2b Eye Drops
国药准字S20020102
生物制品
眼用制剂
4/7/2020
Recombinant Human Interferon α2b for Injection
国药准字S19980083
生物制品
冻干粉针剂
9/21/2020
Recombinant Human Interferon α2b for Injection
国药准字S20090032
生物制品
注射剂
9/6/2021
Recombinant Human Interferon α2b for Injection
国药准字S19980081
生物制品
冻干粉针剂
10/22/2020
Recombinant Human Interferon α2b for Injection
国药准字S20010043
生物制品
冻干粉针剂
8/31/2020
Recombinant Human Interferon α2b for Injection
国药准字S19990025
生物制品
注射剂
7/10/2020
Recombinant Human Interferon α2b for Injection
国药准字S20063024
生物制品
注射剂
7/10/2020
Recombinant Human Interferon α2b for Injection
国药准字S20040028
生物制品
注射剂
7/30/2020
Recombinant Human Interferon α2b for Injection
国药准字S20010074
生物制品
注射剂(冻干)
7/15/2020

PPB Drug Approvals

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