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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

Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

Phase 4
Completed
Conditions
Hepatitis C
Interventions
First Posted Date
2015-11-11
Last Posted Date
2018-09-27
Lead Sponsor
Getz Pharma
Target Recruit Count
64
Registration Number
NCT02601976

Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

First Posted Date
2015-10-28
Last Posted Date
2015-10-28
Lead Sponsor
Huashan Hospital
Target Recruit Count
294
Registration Number
NCT02589652
Locations
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The First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, China

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Fuzhou Municipal Infectious Disease Hospital, Fuzhou, Fujian, China

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The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

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A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

Phase 2
Completed
Conditions
Carcinoma, Hepatocellular
Interventions
First Posted Date
2015-10-15
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
16
Registration Number
NCT02576964

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2015-10-07
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
60
Registration Number
NCT02570191

REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection

Phase 2
Completed
Conditions
Chronic Hepatitis B
Interventions
Drug: REP 2139-Mg
Drug: REP 2165-Mg
First Posted Date
2015-10-01
Last Posted Date
2019-09-10
Lead Sponsor
Replicor Inc.
Target Recruit Count
40
Registration Number
NCT02565719
Locations
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Infectious Clinical Hospital (n.a. Toma Ciorba), Department 4, Chisinau, Moldova, Republic of

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Repiblican Clinical Hospital (ARENSIA unit), Chisinau, Moldova, Republic of

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Infectious Clinical Hospital (n.a. Toma Ciorba) Department 5, Chisinau, Moldova, Republic of

A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2015-09-22
Last Posted Date
2016-02-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
270
Registration Number
NCT02556307

Directly Observed Therapy for HCV in Chennai, India

Phase 2
Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2015-09-04
Last Posted Date
2021-04-15
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Target Recruit Count
50
Registration Number
NCT02541409
Locations
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YR Gaitonde Centre for AIDS Research and Education, Chennai, Tamil Nadu, India

An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

Completed
Conditions
Hepatitis C
Interventions
First Posted Date
2015-08-04
Last Posted Date
2017-04-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
463
Registration Number
NCT02515279
Locations
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A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl., Ried-innkreis, Austria

Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients

Phase 4
Conditions
Chronic Hepatitis B
Interventions
Drug: nucleos(t)ide analgoue
First Posted Date
2015-06-17
Last Posted Date
2015-12-03
Lead Sponsor
Ruijin Hospital
Target Recruit Count
366
Registration Number
NCT02474316
Locations
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The Third People's Hospital of Guilin, Guilin, China

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Shanghai Public Health Clinical Center, Shanghai, China

🇨🇳

Ruijin Hospital, Shanghai, China

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