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
-

S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

First Posted Date
2007-05-21
Last Posted Date
2013-07-05
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
24
Registration Number
NCT00475176
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-02-16
Last Posted Date
2016-10-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
39
Registration Number
NCT00436163

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

First Posted Date
2006-12-14
Last Posted Date
2013-08-08
Lead Sponsor
Human Genome Sciences Inc.
Target Recruit Count
933
Registration Number
NCT00411385
Locations
🇺🇸

Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Baylor University Medical Center, Dallas, Texas, United States

and more 156 locations

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients

First Posted Date
2006-11-22
Last Posted Date
2013-08-08
Lead Sponsor
Human Genome Sciences Inc.
Target Recruit Count
1331
Registration Number
NCT00402428
Locations
🇺🇸

University of New Mexico, Albuquerque, New Mexico, United States

🇺🇸

Maryland Digestive Disease Center, Laurel, Maryland, United States

🇦🇺

Monash Medical Centre, Clayton, Victoria, Australia

and more 162 locations

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

First Posted Date
2006-10-31
Last Posted Date
2010-08-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1175
Registration Number
NCT00394277

High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

First Posted Date
2006-09-28
Last Posted Date
2021-09-01
Lead Sponsor
Foundation for Liver Research
Target Recruit Count
33
Registration Number
NCT00381953
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

Continuing Treatment With Pegasys and Copegus

Phase 3
Conditions
First Posted Date
2006-06-13
Last Posted Date
2006-06-13
Lead Sponsor
Májbetegekért Alapítvány
Target Recruit Count
100
Registration Number
NCT00336518
Locations
🇭🇺

Szt. László Hospital, Budapest, Hungary

Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

Phase 2
Completed
Conditions
First Posted Date
2005-12-06
Last Posted Date
2007-12-21
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
12
Registration Number
NCT00262483
Locations
🇵🇷

Call for information, Santurce, Puerto Rico

Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients

Phase 3
Terminated
Conditions
First Posted Date
2005-09-22
Last Posted Date
2009-02-18
Lead Sponsor
University Hospital, Bonn
Target Recruit Count
2
Registration Number
NCT00221286
Locations
🇩🇪

Praxiszentrum Kaiserdamm, Berlin, Germany

🇩🇪

Immunologische Ambulanz, Medizinische Klinik und Poliklinik I, Bonn University, Bonn, North-Rhine Westfalia, Germany

🇩🇪

Abteilung Klinische Immunologie Zentrum Innere Medizin der Medizinischen Hochschule Hannover, Hannover, Lower Saxony, Germany

and more 2 locations
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