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
-

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

First Posted Date
2010-10-06
Last Posted Date
2016-08-30
Lead Sponsor
Debiopharm International SA
Target Recruit Count
340
Registration Number
NCT01215643
Locations
🇺🇸

The North Texas Research Institute, Arlington, Texas, United States

🇺🇸

Saint Louis University, St. Louis, Missouri, United States

🇺🇸

Liver Associates of Texas, Houston, Texas, United States

and more 19 locations

Ph IIA Study (SOC +/- NS5B)

First Posted Date
2010-09-01
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
39
Registration Number
NCT01193361
Locations
🇺🇸

Options Health Research, Llc, Tulsa, Oklahoma, United States

🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

and more 7 locations

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

First Posted Date
2010-08-17
Last Posted Date
2016-08-25
Lead Sponsor
Debiopharm International SA
Target Recruit Count
459
Registration Number
NCT01183169
Locations
🇬🇧

Novartis Investigative Site, Nottingham, United Kingdom

Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants

First Posted Date
2010-08-12
Last Posted Date
2023-08-30
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
122
Registration Number
NCT01180790
Locations
🇧🇪

Clinical Trial Site, Gent, Oost-Vlaanderen, Belgium

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

First Posted Date
2010-07-28
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
512
Registration Number
NCT01170962
Locations
🇺🇸

Scripps Clinic, La Jolla, California, United States

🇺🇸

Alabama Liver & Digestive Specialists (Alds), Montgomery, Alabama, United States

🇺🇸

Liver Associates Of Texas, Houston, Texas, United States

and more 34 locations

Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

First Posted Date
2010-06-14
Last Posted Date
2013-02-04
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
205
Registration Number
NCT01143662
Locations
🇨🇳

Tianjin Third Central Hospital, Tianjin, China

🇨🇳

First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China

🇨🇳

Tangdu Hospital, Fourth Military Medical University, Xian, China

and more 36 locations

Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

First Posted Date
2010-06-10
Last Posted Date
2013-02-04
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
211
Registration Number
NCT01140997
Locations
🇨🇳

302 Military Hospital, Beijing, China

🇨🇳

Peking University People's Hospital, Beijing, China

🇨🇳

Xiangya Second Hospital, Central-south University, Changsha, China

and more 35 locations

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

First Posted Date
2010-05-18
Last Posted Date
2015-10-23
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
558
Registration Number
NCT01125189
Locations
🇺🇸

University Of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Johns Hopkins University, Lutherville, Maryland, United States

🇺🇸

Cli, Los Angeles, California, United States

and more 33 locations
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