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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

EMA Approves Loba Biotech as New Manufacturing Site for Pegasys, Restoring European Supply

• The European Medicines Agency has approved pharma&'s manufacturing subsidiary Loba biotech as a production site for Pegasys (peginterferon alfa-2a), enabling replenishment of supplies across Europe. • pharma& acquired global rights to Pegasys in 2021 after Roche announced discontinuation, investing significantly in Loba biotech's manufacturing capabilities to meet increased patient demand. • The approval represents a critical step in pharma&'s mission to ensure continuous availability of essential medicines, with efforts underway to enhance Pegasys accessibility in the US and other regions.

Arbutus Biopharma to Present Promising Imdusiran and AB-101 Data for Chronic Hepatitis B at EASL Congress 2025

• Arbutus Biopharma will present five abstracts at EASL Congress 2025, showcasing data on imdusiran and AB-101 for chronic hepatitis B treatment, including one late-breaker abstract. • Clinical data reveals that imdusiran, when combined with pegylated interferon and nucleos(t)ide analogue therapy, achieved meaningful functional cure rates in chronic hepatitis B patients through targeted RNAi action. • AB-101, an oral PD-L1 inhibitor, demonstrated promising safety profiles and dose-responsive receptor occupancy in early trials, potentially offering controlled immune checkpoint blockade with fewer systemic side effects than antibody therapies.

Protara Therapeutics Announces Key Milestones for 2025, Including NMIBC and LM Data

• Protara Therapeutics anticipates mid-2025 data from the ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC) patients, building on positive six-month results. • The company expects to initiate the THRIVE-3 registrational trial of IV Choline Chloride for parenteral support-dependent patients in the first half of 2025. • By the end of the first half of 2025, Protara plans to release data from additional cohorts of the Phase 2 STARBORN-1 trial of TARA-002 in pediatric lymphatic malformations (LMs). • With approximately $181.5 million in funding, Protara's financial runway extends into 2027, supporting its clinical development programs.

Combination Therapies Show Promise for Functional Cure of Chronic Hepatitis B

• A Phase II trial of xalnesiran plus immunomodulators showed significant hepatitis B surface antigen (HBsAg) loss in patients with chronic HBV infection. • VTP-300 combined with low-dose nivolumab demonstrated sustained HBsAg reductions, meeting functional cure criteria in a Phase 2b trial. • Both studies highlight the potential for novel combination therapies to achieve functional cures and allow patients to discontinue lifelong antiviral treatment. • Further research is needed to address challenges in durability of response and efficacy in patients with high HBsAg levels.

Ruxolitinib Plus Pegylated Interferon Alfa-2a Shows Promise in Polycythemia Vera

• Combination therapy with ruxolitinib and pegylated interferon alfa-2a demonstrates safety and efficacy in newly diagnosed polycythemia vera (PV) patients. • The COMBI II trial showed significant reductions in _JAK2_ V617F variant allele frequency and improvements in bone marrow cellularity and fibrosis. • Overall remission rates reached 56% at 24 months, with a notable proportion of patients achieving partial or complete molecular responses. • The treatment regimen exhibited an acceptable toxicity profile, supporting its potential as a promising option for PV management.

FDA Approves Roche's Ocrevus (Zunovo) for Multiple Sclerosis

• The U.S. Food and Drug Administration (FDA) has approved Roche's Ocrevus (Zunovo) for the treatment of multiple sclerosis, offering a new therapeutic option. • Ocrevus, developed by Roche, represents a significant advancement in the treatment landscape for patients with relapsing and progressive forms of MS. • Roche's Ocrevus is part of a broad portfolio of pharmaceutical products targeting various disease areas, including immunology and neuroscience. • The approval underscores Roche's commitment to developing innovative medicines and diagnostic tools across a range of therapeutic areas.

Advances in Prognostication and Treatment of Polycythemia Vera with Pegylated Interferon and MDM2 Inhibition

Recent studies highlight the efficacy of pegylated interferon (IFN) and MDM2 inhibition in treating Polycythemia Vera (PV), a type of myeloproliferative neoplasm. Pegylated IFN, particularly IFN-α, shows promise in normalizing blood counts, reducing phlebotomy needs, and potentially inducing molecular remissions. Despite its benefits, IFN's side effects limit its use. MDM2 inhibitors, targeting the TP53 pathway, offer a novel approach, with clinical trials demonstrating reduced JAK2V617F allele burdens and improved patient outcomes. These advancements underscore the evolving landscape of PV treatment, emphasizing the need for further research to optimize therapeutic strategies.
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