MedPath

Peginterferon alfa-2a

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

Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

Phase 1
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2017-09-05
Last Posted Date
2018-08-21
Lead Sponsor
Enyo Pharma
Target Recruit Count
73
Registration Number
NCT03272009
Locations
🇦🇺

Scientia Clinical Research Limited, Sydney, New South Wales, Australia

🇳🇱

Academic Medical Centre (AMC), Amsterdam, Netherlands

🇳🇱

Erasmus MC, Rotterdam, Netherlands

and more 6 locations

The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

Phase 4
Conditions
Chronic Hepatitis b
Hepatic Carcinoma
Interventions
Drug: ETV;TDF;ADV
First Posted Date
2017-08-17
Last Posted Date
2017-09-08
Lead Sponsor
Huashan Hospital
Target Recruit Count
432
Registration Number
NCT03253250
Locations
🇨🇳

Huashan Hospital, Shanghai, China

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Not Applicable
Conditions
Chronic Hepatitis B Infection
Interventions
First Posted Date
2017-07-07
Last Posted Date
2017-07-12
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
120
Registration Number
NCT03210493
Locations
🇨🇳

Beijing Ditan hospital,Capital Medical University, Beijing, Beijing, China

The Changes of Cytokines During Antiviral Therapy

Not Applicable
Conditions
Chronic Hepatitis B Infection
Interventions
First Posted Date
2017-07-07
Last Posted Date
2017-07-12
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
120
Registration Number
NCT03210506
Locations
🇨🇳

Beijing Ditan hospital,Capital Medical University, Beijing, Beijing, China

The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy

Phase 4
Conditions
Chronic Hepatitis B Infection
Interventions
First Posted Date
2017-07-06
Last Posted Date
2017-07-12
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
100
Registration Number
NCT03209037
Locations
🇨🇳

Beijing Ditan hospital,Capital Medical University, Beijing, Beijing, China

The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy

Phase 4
Conditions
Chronic Hepatitis B Infection
Interventions
First Posted Date
2017-07-06
Last Posted Date
2017-07-12
Lead Sponsor
Yao Xie
Target Recruit Count
100
Registration Number
NCT03209011
Locations
🇨🇳

Beijing Ditan hospital,Capital Medical University, Beijing, Beijing, China

The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy

Phase 4
Conditions
Chronic Hepatitis B Infection
Interventions
First Posted Date
2017-07-06
Last Posted Date
2017-07-12
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
100
Registration Number
NCT03208998
Locations
🇨🇳

Beijing Ditan hospital,Capital Medical University, Beijing, Beijing, China

Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

Completed
Conditions
Hepatitis B
Interventions
First Posted Date
2017-06-08
Last Posted Date
2021-04-13
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
473
Registration Number
NCT03181113
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

🇨🇳

Second Affiliated Hospital Chongqing Medical University, Chongqing, Chongqing, China

🇨🇳

Southwest Hospital, Chongqing, Chongqing, China

and more 25 locations

A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects

Phase 2
Withdrawn
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2017-04-24
Last Posted Date
2017-10-16
Lead Sponsor
Alios Biopharma Inc.
Registration Number
NCT03125213

Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

Phase 1
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2017-04-12
Last Posted Date
2018-07-06
Lead Sponsor
Assembly Biosciences
Target Recruit Count
38
Registration Number
NCT03109730
Locations
🇨🇳

Keelung Chang Gung Memorial Hospital, Keelung, Taiwan

🇬🇧

Royal London Hospital, London, United Kingdom

🇦🇺

The Alfred Hospital, Melbourne, Victoria, Australia

and more 11 locations
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