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Peginterferon alfa-2a

Generic Name
Peginterferon alfa-2a
Brand Names
Pegasys
Drug Type
Biotech
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

A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

Phase 3
Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2013-05-14
Last Posted Date
2013-09-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
272
Registration Number
NCT01853254

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

Terminated
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2013-02-26
Last Posted Date
2016-09-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
282
Registration Number
NCT01798576

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

Phase 3
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2013-01-03
Last Posted Date
2015-08-31
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
820
Registration Number
NCT01760122
Locations
🇨🇳

Beijing Youan Hospital, Capital Medical University, Beijing, China

🇨🇳

Xiangya Hospital, Central-south University, Changsha, China

🇨🇳

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

and more 40 locations

Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis

Phase 2
Terminated
Conditions
Myelofibrosis
Interventions
First Posted Date
2013-01-01
Last Posted Date
2018-07-24
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
8
Registration Number
NCT01758588
Locations
🇺🇸

Weill Medial College of Cornell Universiy, New York, New York, United States

🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Phase 3
Completed
Conditions
Chronic Hepatitis C (CHC)
Interventions
First Posted Date
2012-12-20
Last Posted Date
2016-10-03
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
54
Registration Number
NCT01753557
Locations
🇯🇵

Toranomon Hospital, Kawasaki City, Takatsu-ku, Japan

HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

Phase 3
Completed
Conditions
HIV Infections
Hepatitis C
COINFECTION
Interventions
First Posted Date
2012-10-31
Last Posted Date
2015-07-09
Lead Sponsor
Anna Cruceta
Target Recruit Count
128
Registration Number
NCT01718301
Locations
🇪🇸

Hospital Clinic i Provincial de Barcelona, Barcelona, Spain

Randomized Controlled Open Label Trial of Peg Alpha 2a Interferon and Adjusted-dose of Ribavirin vs. Standard Therapy in the Treatment of Naive Chronic Hepatitis C Patients Infected With Genotype 4

Phase 4
Completed
Conditions
Chronic Hepatitis C Virus
Interventions
First Posted Date
2012-09-18
Last Posted Date
2016-02-24
Lead Sponsor
King Abdulaziz Medical City
Target Recruit Count
181
Registration Number
NCT01686789
Locations
🇸🇦

King Khaled University Hospital, Riyadh, Saudi Arabia

🇸🇦

King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia

🇸🇦

King Abdulaziz Medical City, Riyadh, Saudi Arabia

A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2012-08-08
Last Posted Date
2017-10-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
516
Registration Number
NCT01659567
Locations
🇬🇪

Hepatology Clinic Hepa, Tbilisi, Georgia

🇬🇪

Ltd Mrcheveli, Tbilisi, Georgia

🇬🇪

Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia

Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C

Phase 4
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2012-07-25
Last Posted Date
2013-01-15
Lead Sponsor
MinaPharm Pharmaceuticals
Target Recruit Count
5000
Registration Number
NCT01649245
Locations
🇪🇬

National Liver Institute, Shebin El-Kom, Menoufiya, Egypt

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