title: Safety of peginterferon alfa-2a (40KD) treatment in patients with chronic hepatitis B infection: an observational, multicenter, open label, non-interventional study in Turkish patients.
abstract: OBJECTIVE
  Pegylated alfa interferon is the only immunomodulatory drug licensed for hepatitis B. We evaluated the safety and tolerability of peginterferon alfa-2a (40KD) in patients with chronic hepatitis B.
  
  
  METHODS
  A total of 113 chronic hepatitis B patients under peginterferon alfa-2a (40KD; 180 μg/week) treatment were included in this multicenter, open label, non-interventional study, and 66 patients completed the follow-up period. Vital signs, physical examination and laboratory findings, concomitant medications, and adverse events were recorded. A Quality of Life questionnaire (Short Form-36) was performed twice, at the beginning and at the end of the study.
  
  
  RESULTS
  There was no significant difference between initial and last visits in terms of physical examination findings and Short Form-36 scores. A total of 27 adverse events were reported in 15 patients (22.7%), with most of them being mild in intensity (70.4%). The rates of the adverse events were similar in the monotherapy and combination therapy groups (peginterferon alfa-2a + lamivudine, peginterferon alfa-2a + adefovir or peginterferon alfa-2a + entecavir therapy groups), at 23.7% and 14.3%, respectively. The dosage of peginterferon had to be reduced in 3 patients (4.5%) due to thrombocytopenia. Overall patient compliance to treatment was detected as 85.9%.
  
  
  CONCLUSIONS
  Based on the lack of serious adverse events and absence of impairment in Quality of Life, peginterferon alfa-2a (40KD, 180 μg/week, subcutaneously) treatment for 48 weeks led to a high level of patient compliance and was associated with a high degree of safety and tolerability for the treatment of adult patients with chronic hepatitis B in real-life practice.
authors.affiliation: Department of Gastroenterology, Acıbadem University, Acıbadem Kozyatağı Hospital, Kozyatağı, İstanbul, Turkey. nurdan.tozun@acibadem.edu.tr
authors.forename: Nurdan
authors.initials: N
authors.lastname: Tözün
authors.forename: Orhan
authors.initials: O
authors.lastname: Sezgın
authors.forename: Murat
authors.initials: M
authors.lastname: Gülşen
authors.forename: Sabite
authors.initials: S
authors.lastname: Kacar
authors.forename: Necati
authors.initials: N
authors.lastname: Yenıce
authors.forename: Şerif
authors.initials: Ş
authors.lastname: Yilmaz
authors.forename: Saadettin
authors.initials: S
authors.lastname: Hülagü
authors.forename: Bülent
authors.initials: B
authors.lastname: Kantarçeken
authors.forename: Fahri
authors.initials: F
authors.lastname: Yakaryilmaz
authors.forename: Alper
authors.initials: A
authors.lastname: Yurcı
authors.forename: Kemal Mustafa
authors.initials: KM
authors.lastname: Serez
authors.forename: Halil
authors.initials: H
authors.lastname: Bahçecıoğlu
authors.forename: Sait
authors.initials: S
authors.lastname: Bağci
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a