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
-

An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis

First Posted Date
2012-05-31
Last Posted Date
2017-04-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1496
Registration Number
NCT01609049
Locations
🇷🇺

Kirov Region Aids-Center; Infectious, Kirov, Russian Federation

🇷🇺

Infections Deseases Hospital #1, Novosibirsk, Russian Federation

🇷🇺

Krasnoyarsk Region Aids Center; Hepatology, Krasnoyarsk, Russian Federation

and more 54 locations

Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

Not Applicable
Conditions
Interventions
First Posted Date
2012-05-15
Last Posted Date
2012-05-15
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
60
Registration Number
NCT01599130
Locations
🇨🇳

The Third Affliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients

First Posted Date
2012-05-04
Last Posted Date
2016-06-15
Lead Sponsor
University of Chicago
Target Recruit Count
3
Registration Number
NCT01592006
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

First Posted Date
2012-04-09
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
398
Registration Number
NCT01573351
Locations
🇺🇸

University Of Chicago Medical Center, Chicago, Illinois, United States

🇺🇸

Gastro One, Germantown, Tennessee, United States

🇨🇳

Local Institution, Taipei, Taiwan

and more 18 locations

Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

First Posted Date
2011-12-28
Last Posted Date
2016-08-01
Lead Sponsor
Debiopharm International SA
Target Recruit Count
6
Registration Number
NCT01500772
Locations
🇩🇪

Novartis Investigational Site, Mainz, Germany

🇬🇧

Novartis Investigative Site, London, United Kingdom

🇺🇸

Novartis Investigational site, Bradenton, Florida, United States

Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

First Posted Date
2011-12-15
Last Posted Date
2016-06-03
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
605
Registration Number
NCT01492426
Locations
🇺🇸

The Kirklin Clinic, Birmingham, Alabama, United States

🇺🇸

Atlanta Medical Center, Atlanta, Georgia, United States

🇺🇸

Medical Associates Research Group, San Diego, California, United States

and more 23 locations

A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

First Posted Date
2011-11-30
Last Posted Date
2017-04-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
80
Registration Number
NCT01482390
Locations
🇺🇸

Carolina'S Center For Liver Disease, Statesville, North Carolina, United States

🇺🇸

Harborview Medical Center, Seattle, Washington, United States

🇺🇸

Birmingham Gastro Associates, P.C., Birmingham, Alabama, United States

and more 36 locations

HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-11-15
Last Posted Date
2015-03-10
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
20
Registration Number
NCT01471535
Locations
🇨🇳

liver disease center, Beijing Ditan Hospital, Beijing, Beijing, China

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