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 Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

First Posted Date
2011-11-08
Last Posted Date
2015-06-18
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
61
Registration Number
NCT01467505
Locations
🇺🇸

New York, Rochester, New York, United States

🇺🇸

North Carolina, Charlotte, North Carolina, United States

🇺🇸

Missouri, St Louis, Missouri, United States

and more 13 locations

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

First Posted Date
2011-10-26
Last Posted Date
2015-06-10
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
239
Registration Number
NCT01459913
Locations
🇺🇸

Virginia, Fairfax, Virginia, United States

🇺🇸

Pennsylvania, Hershey, Pennsylvania, United States

🇮🇱

Israel, Jerusalem, Israel

and more 1 locations

HBsAg Related Response Guided Therapy

First Posted Date
2011-10-20
Last Posted Date
2012-10-31
Lead Sponsor
Gangnam Severance Hospital
Target Recruit Count
200
Registration Number
NCT01456312
Locations
🇰🇷

Shinchon Severance Hospital, Seoul, Korea, Republic of

Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

First Posted Date
2011-10-07
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
152
Registration Number
NCT01448044
Locations
🇺🇸

University Gastroenterology, Providence, Rhode Island, United States

🇺🇸

Metropolitan Research, Annandale, Virginia, United States

🇬🇧

Local Institution, London, Greater London, United Kingdom

and more 2 locations

Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

First Posted Date
2011-10-05
Last Posted Date
2017-01-16
Lead Sponsor
Debiopharm International SA
Target Recruit Count
8
Registration Number
NCT01446250
Locations
🇺🇸

Novartis Investigational Site, Baltimore, Maryland, United States

Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

First Posted Date
2011-09-23
Last Posted Date
2017-12-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
16
Registration Number
NCT01439373
Locations
🇵🇷

GSK Investigational Site, San Juan, Puerto Rico

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

First Posted Date
2011-09-02
Last Posted Date
2016-05-27
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
276
Registration Number
NCT01428063
Locations
🇺🇸

Scpmg/ Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

🇺🇸

Mercy Medical Center, Baltimore, Maryland, United States

🇺🇸

University Of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 18 locations

Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism

First Posted Date
2011-08-11
Last Posted Date
2017-05-09
Lead Sponsor
University of Vermont
Registration Number
NCT01415141
Locations
🇺🇸

Emory University School of Medicine, Atlanta, Georgia, United States

🇺🇸

Fletcher Allen Health Care, Burlington, Vermont, United States

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