MedPath

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
-

Lonafarnib With and Without Ritonavir in HDV (LOWR-1)

Phase 2
Completed
Conditions
Chronic Hepatitis D Infection
Interventions
First Posted Date
2015-04-30
Last Posted Date
2022-11-29
Lead Sponsor
Eiger BioPharmaceuticals
Target Recruit Count
21
Registration Number
NCT02430181
Locations
🇹🇷

Ankara University Medical School, Ankara, Turkey

Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment

Phase 2
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2015-02-18
Last Posted Date
2019-09-04
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
14
Registration Number
NCT02364336
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase

Phase 3
Completed
Conditions
Pediatric Immuno-Tolerant Chronic Hepatitis B
Interventions
First Posted Date
2014-10-13
Last Posted Date
2020-08-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
62
Registration Number
NCT02263079
Locations
🇧🇪

Cliniques Universitaires St-Luc, Bruxelles, Belgium

🇮🇹

Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive, Bologna, Emilia-Romagna, Italy

🇩🇪

Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II, Essen, Germany

and more 22 locations

An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study

Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2014-07-28
Last Posted Date
2017-08-31
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT02201407
Locations
🇷🇸

Clinical Center Zemun, Belgrade, Serbia

🇷🇸

Clinic for Gastroenterology and Hepatology, Belgrade, Serbia

🇷🇸

Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology, Novi Sad, Serbia

and more 3 locations

A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors

First Posted Date
2014-06-25
Last Posted Date
2020-05-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
158
Registration Number
NCT02174172
Locations
🇺🇸

HonorHealth Research Institute - Bisgrove, Scottsdale, Arizona, United States

🇺🇸

UCLA, Los Angeles, California, United States

🇺🇸

Yale University, New Haven, Connecticut, United States

and more 6 locations

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Phase 2
Completed
Conditions
Hepatitis C Virus Genotype 4 Infection
Interventions
First Posted Date
2014-04-08
Last Posted Date
2017-01-24
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
60
Registration Number
NCT02107365
Locations
🇫🇷

Hôpital Jean Verdier, Bondy, France

🇫🇷

Hôpital de Haut Lévêque, Bordeaux Pessac, France

🇫🇷

Hôpital Beaujon, Clichy, France

and more 22 locations

Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C

Phase 4
Completed
Conditions
HIV
Hepatitis C, Chronic
Interventions
First Posted Date
2013-08-19
Last Posted Date
2017-03-16
Lead Sponsor
Markus Peck-Radosavljevic
Target Recruit Count
6
Registration Number
NCT01925183
Locations
🇦🇹

Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria

Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1

Phase 2
Withdrawn
Conditions
Hepatitis C
Interventions
First Posted Date
2013-07-02
Last Posted Date
2014-05-14
Lead Sponsor
Timothy Morgan, MD
Registration Number
NCT01890772
Locations
🇺🇸

Minneapolis VAHCS, Minneapolis, Minnesota, United States

🇺🇸

VA Long Beach Healthcare System, Long Beach, California, United States

🇺🇸

Kansas City VA Medical Center, Kansas City, Missouri, United States

and more 1 locations

The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

Phase 3
Withdrawn
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2013-07-01
Last Posted Date
2017-04-28
Lead Sponsor
TCM Biotech International Corp.
Registration Number
NCT01890200
Locations
🇨🇳

Chang Gung Memorial Hospital, Taoyuan, Taiwan

🇨🇳

Peking University People's Hospit, Beijing, Beijing, China

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