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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

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Phase 4
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2025-04-10
Last Posted Date
2025-04-10
Lead Sponsor
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Target Recruit Count
100
Registration Number
NCT06922643

Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis

Not Applicable
Recruiting
Conditions
Bronchiolitis
Interventions
Drug: Peginterferon α-2b injection
First Posted Date
2025-02-14
Last Posted Date
2025-02-14
Lead Sponsor
Children's Hospital of Soochow University
Target Recruit Count
90
Registration Number
NCT06827249
Locations
🇨🇳

Wuhan Women and Children's Health Care Center, Wuhan, Hubei, China

🇨🇳

Children's Hospital of Soochow University, Suzhou, Jiangsu, China

🇨🇳

The First Hospital of Jilin University, Changchun, Jilin, China

A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

Phase 1
Terminated
Conditions
Healthy Participants
Interventions
First Posted Date
2023-11-22
Last Posted Date
2025-02-06
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
267
Registration Number
NCT06144697
Locations
🇺🇸

Local Institution - 0003, Austin, Texas, United States

🇺🇸

Local Institution - 0001, Anaheim, California, United States

Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis

Phase 2
Withdrawn
Conditions
Chronic Hepatitis Delta
Interventions
First Posted Date
2023-07-20
Last Posted Date
2024-05-23
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registration Number
NCT05953545
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Cemiplimab/Peg-Interferon-α in Advanced CSCC

Phase 1
Withdrawn
Conditions
Cutaneous Squamous Cell Carcinoma
Squamous Cell Carcinoma
Advanced Squamous Cell Carcinoma
Interventions
First Posted Date
2023-02-15
Last Posted Date
2023-08-09
Lead Sponsor
Baptist Health South Florida
Registration Number
NCT05729139
Locations
🇺🇸

Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States

Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: P1101 (48 mcg)
Drug: P1101 (24 mcg)
Drug: P1101 (180 mcg)
Drug: P1101 (270 mcg)
Drug: P1101 (225 mcg)
Drug: P1101 (90 mcg)
First Posted Date
2021-11-22
Last Posted Date
2022-01-18
Lead Sponsor
PharmaEssentia
Target Recruit Count
48
Registration Number
NCT05129644
Locations
🇨🇦

Anapharm, Québec, Canada

Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression

Phase 2
Recruiting
Conditions
Colon Cancer
Interventions
Drug: Saline
First Posted Date
2021-03-15
Last Posted Date
2023-08-18
Lead Sponsor
Zealand University Hospital
Target Recruit Count
68
Registration Number
NCT04798612
Locations
🇩🇰

Herlev University Hospital, Herlev, Zealand, Denmark

Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis

Not Applicable
Conditions
Liver Fibrosis
Hepatitis B
Interventions
First Posted Date
2019-04-19
Last Posted Date
2019-05-22
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
100
Registration Number
NCT03920605
Locations
🇨🇳

Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis

Not Applicable
Conditions
Liver Fibrosis
Hepatitis B
Interventions
First Posted Date
2019-04-18
Last Posted Date
2019-04-19
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
120
Registration Number
NCT03919565
Locations
🇨🇳

Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

Phase 2
Completed
Conditions
Hepatitis C, Chronic
Interventions
First Posted Date
2018-03-29
Last Posted Date
2021-05-18
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Target Recruit Count
150
Registration Number
NCT03480932
Locations
🇮🇳

YR Gaitonde Centre for AIDS Education and Johns Hopkins University Collaborative Integrated Care Center (YRG-JHU ICC), Bilaspur, Chhattisgarh, India

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