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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 Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2016-06-06
Last Posted Date
2017-02-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT02791269

A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6

Phase 3
Terminated
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2016-06-06
Last Posted Date
2016-06-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT02791256

HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Not Applicable
Completed
Conditions
Chronic Hepatitis B (HBeAg-negative)
Interventions
First Posted Date
2016-04-19
Last Posted Date
2019-09-06
Lead Sponsor
José Antonio Carrion
Target Recruit Count
119
Registration Number
NCT02743182

Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)

Phase 3
Completed
Conditions
Myelogenous Leukemia, Chronic
Interventions
First Posted Date
2016-04-13
Last Posted Date
2016-09-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
41
Registration Number
NCT02736721

A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

Phase 2
Completed
Conditions
Hepatitis D, Chronic
Interventions
First Posted Date
2016-04-07
Last Posted Date
2016-07-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
12
Registration Number
NCT02731131

A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2016-04-01
Last Posted Date
2016-08-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
114
Registration Number
NCT02726022

SR-BI and Antiviral Treatment Response in HCV

Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2016-03-21
Last Posted Date
2017-07-14
Lead Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Target Recruit Count
309
Registration Number
NCT02714712

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Phase 1
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2016-01-05
Last Posted Date
2016-01-05
Lead Sponsor
Replicor Inc.
Target Recruit Count
12
Registration Number
NCT02646189
Locations
🇧🇩

Farabi General Hospital, Dhaka, Bangladesh

A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC)

Phase 4
Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2015-12-29
Last Posted Date
2016-08-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
737
Registration Number
NCT02641379

A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2015-11-13
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
307
Registration Number
NCT02604823
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