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
-

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

First Posted Date
2009-12-11
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
285
Registration Number
NCT01030432
Locations
🇺🇸

Umass Memorial Medical Center, Worcester, Massachusetts, United States

🇺🇸

Hospital Of The University Of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

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

and more 13 locations

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

First Posted Date
2009-11-20
Last Posted Date
2015-09-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
55
Registration Number
NCT01017575
Locations
🇯🇵

Local Institution, Musashino-Shi, Tokyo, Japan

Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection

First Posted Date
2009-10-27
Last Posted Date
2011-12-05
Lead Sponsor
ZymoGenetics
Target Recruit Count
600
Registration Number
NCT01001754

Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-06-10
Last Posted Date
2012-12-20
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
42
Registration Number
NCT00917358
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇨🇳

Chiayi Christian Hospital, Chiayi, Taiwan

🇨🇳

Buddhist Tzu Chi General Hospital, Chiayi, Taiwan

and more 2 locations

Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

First Posted Date
2009-05-04
Last Posted Date
2015-03-20
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
15
Registration Number
NCT00892697

A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

First Posted Date
2008-12-02
Last Posted Date
2017-05-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
372
Registration Number
NCT00800748

The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection

First Posted Date
2007-11-12
Last Posted Date
2014-08-07
Lead Sponsor
TCM Biotech International Corp.
Target Recruit Count
84
Registration Number
NCT00556504
Locations
🇨🇳

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

First Posted Date
2007-09-10
Last Posted Date
2009-01-29
Lead Sponsor
Hospital Carlos III, Madrid
Target Recruit Count
384
Registration Number
NCT00526448
Locations
🇪🇸

Hospital Parc Taulí, Sabadell, Barcelona, Spain

🇪🇸

Hospital do Meixoeiro, Vigo, Pontevedra, Spain

🇪🇸

Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain

and more 37 locations

Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C

First Posted Date
2007-06-26
Last Posted Date
2014-02-10
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
377
Registration Number
NCT00491244
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

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