title: The efficacy of a Hansenula-derived 20 kDa pegylated interferon alpha-2a in the treatment of genotype 4 chronic hepatitis C.
abstract: Pending the emergence and approval of an effective interferon-free regimen, pegylated interferon will remain an integral part of the treatment of genotype 4 hepatitis C virus (HCV). A new 20 kDa pegylated interferon has been developed in a cost-saving fungal-based system and is commercialized in Egypt at a quarter to a third of the price of conventional pegylated interferon. We hereby test the efficacy and safety of this novel cost-saving interferon. One hundred ninety-three consecutive treatment-naive patients with genotype 4 HCV were treated using the following regimen: subcutaneous 20 kDa pegylated interferon 160 μg once weekly plus oral ribavirin 1,000 or 1,200 mg daily (based on body weight <75 kg or ≥75 kg, respectively) for 48 weeks. A sustained virological response (SVR) of 51% was achieved. Interim responses included rapid virological response (RVR): 54%, early virological response (EVR): 78% (complete EVR: 71%, partial EVR: 7%), and end of treatment response: 63%. The most common adverse events were flu-like symptoms, dyspepsia, anorexia, and pruritus. Treatment-related serious adverse events were encountered in only 2 patients (1%). Discontinuation of treatment due to adverse events occurred in only 13 patients (7%). Multiple logistic regression analyses revealed the following factors as predictors of SVR: RVR (P<0.001), alpha-fetoprotein<upper limit of normal (ULN) (P=0.007), and early biochemical response (alanine aminotransferase <ULN at week 12, P=0.018). Hansenula-derived 20 kDa pegylated interferon alpha-2a is an effective and safe treatment for genotype 4 chronic HCV. These results highlight the presence of a less costly treatment for chronic HCV, pending the emergence of an effective inexpensive interferon-free regimen. A direct comparison with 40 kDa interferon remains essential to adequately compare the efficacy and safety.
authors.affiliation: 1 Division of Gastroenterology and Hepatology, Endemic Medicine Department, Faculty of Medicine, Cairo University , Cairo, Egypt .
authors.forename: Hany
authors.initials: H
authors.lastname: Shehab
authors.forename: Tamer
authors.initials: T
authors.lastname: Elbaz
authors.forename: Dalia
authors.initials: D
authors.lastname: Deraz
authors.forename: Amal
authors.initials: A
authors.lastname: Hafez
authors.forename: Inas
authors.initials: I
authors.lastname: Elattar
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000379:methods; D004534:Egypt; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010843:Pichia / Q000378:metabolism*; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
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