MedPath

Peginterferon alfa-2a

Generic Name
Peginterferon alfa-2a
Brand Names
Pegasys
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

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
Drug: Peginterferon Alfa-2A
Drug: AL-3778
Drug: Placebo Oral Tablet
First Posted Date
2017-04-24
Last Posted Date
2017-10-16
Lead Sponsor
Alios Biopharma Inc.
Registration Number
NCT03125213

The Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC

Phase 4
Conditions
Hepatitis B
Interventions
Drug: Adefovir, entecavir,tenofovir, either of them
Drug: Peginterferon Alfa-2A
First Posted Date
2017-03-20
Last Posted Date
2017-05-03
Lead Sponsor
Shanghai Nanhui Nanhua Hospital
Target Recruit Count
150
Registration Number
NCT03084250
Locations
🇨🇳

Nanhua Hospital, Shanghai, China

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

Phase 3
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2017-01-13
Last Posted Date
2021-03-23
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
141
Registration Number
NCT03020082

Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2017-01-13
Last Posted Date
2018-07-26
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
70
Registration Number
NCT03020004

Peg-interferon for Inactive Chronic Hepatitis B Carriers

Phase 2
Conditions
Chronic Hepatitis, B Virus
Carrier of Viral Hepatitis Type B
Interventions
First Posted Date
2016-12-14
Last Posted Date
2019-03-19
Lead Sponsor
Seng Gee Lim
Target Recruit Count
90
Registration Number
NCT02992704
Locations
🇸🇬

National University Hospital, Singapore, Singapore

A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs

Phase 4
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2016-09-09
Last Posted Date
2016-09-12
Lead Sponsor
Henan Provincial People's Hospital
Target Recruit Count
114
Registration Number
NCT02894918
Locations
🇨🇳

Weishi County People's Hospital, Kaifeng, Henan, China

🇨🇳

Henan People's Hospital, Zhengzhou, Henan, China

🇨🇳

Shangqiu No.1 People's Hospital, Shangqiu, Henan, China

and more 2 locations

A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

Phase 4
Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2016-08-11
Last Posted Date
2016-08-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
63
Registration Number
NCT02864199

A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

Phase 2
Completed
Conditions
Malignant Melanoma
Chronic Myelogenous Leukemia
Renal Cell Carcinoma
Interventions
Drug: Pegylated Interferon Alfa-2a
Drug: Recombinant Interferon Alfa 2a
First Posted Date
2016-07-12
Last Posted Date
2017-01-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
9
Registration Number
NCT02829775
© Copyright 2025. All Rights Reserved by MedPath