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
-

BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

First Posted Date
2011-07-08
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
448
Registration Number
NCT01389323
Locations
🇺🇸

Greater Los Angeles Healthcare System, Los Angeles, California, United States

🇺🇸

Triple O Research Institute, P.A., West Palm Beach, Florida, United States

🇺🇸

University Of Miami, Miami, Florida, United States

and more 33 locations

PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients

First Posted Date
2011-06-15
Last Posted Date
2019-11-08
Lead Sponsor
Foundation for Liver Research
Target Recruit Count
90
Registration Number
NCT01373684
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Zuid Holland, Netherlands

🇳🇱

Reinier de Graaf Gasthuis, Delft, Netherlands

🇳🇱

Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands

and more 5 locations

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects

First Posted Date
2011-04-27
Last Posted Date
2012-01-31
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
39
Registration Number
NCT01343186
Locations
🇨🇳

302 Military Hospital of China, Beijing, China

Treatment of Recently Acquired Hepatitis C Virus Infection

First Posted Date
2011-04-15
Last Posted Date
2015-09-02
Lead Sponsor
Kirby Institute
Target Recruit Count
82
Registration Number
NCT01336010
Locations
🇦🇺

Alfred Hospital, Melbourne, Victoria, Australia

🇦🇺

Royal Melbourne Hospital, Parkville, Victoria, Australia

🇦🇺

St Vincent's Hospital, Darlinghurst, New South Wales, Australia

and more 5 locations

Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

First Posted Date
2011-03-18
Last Posted Date
2016-09-30
Lead Sponsor
Debiopharm International SA
Target Recruit Count
1081
Registration Number
NCT01318694
Locations
🇻🇳

Novartis Investigative Site, Ho Chi Minh, Vietnam

Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

Completed
Conditions
First Posted Date
2011-03-10
Last Posted Date
2013-07-30
Lead Sponsor
China Medical University Hospital
Target Recruit Count
103
Registration Number
NCT01311947
Locations
🇨🇳

China Medical University Hospital, Taichung, Taiwan

Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

First Posted Date
2011-01-13
Last Posted Date
2013-05-03
Lead Sponsor
Cairo University
Target Recruit Count
100
Registration Number
NCT01276756
Locations
🇪🇬

Cairo University, Cairo, Egypt

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

First Posted Date
2010-12-09
Last Posted Date
2015-12-14
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
196
Registration Number
NCT01257204
Locations
🇺🇸

California Liver Institute, Los Angeles, California, United States

🇮🇹

Local Institution, Viale Del Policlinico, 155, Italy

🇺🇸

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

and more 2 locations
© Copyright 2024. All Rights Reserved by MedPath