title: Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: results from Kyushu University Liver Disease Study.
abstract: OBJECTIVE
  Pegylated interferon (PEG-IFN) α-2b and ribavirin (RBV) treatment of chronic hepatitis C virus (HCV) infection is associated with a substantially elevated risk of discontinuation. The aim of this study is to evaluate the reason for premature discontinuation during PEG-IFN α-2b and RBV treatment due to adverse effects in patients with chronic HCV infection.
  
  
  METHODS
  A total of 2871 Japanese patients who had chronic HCV infection treated with PEG-IFN α-2b and RBV were screened. We prospectively investigated the reasons for premature discontinuation of treatment classified by sex and age, and analyzed the timing of discontinuation.
  
  
  RESULTS
  Of the 2871 patients, 250 (8.7%) discontinued treatment because of adverse effects. The main reasons for premature discontinuation were neurovegetative symptoms (n = 77, 30.8%), depression-related syndrome (n = 46, 18.4%), hematologic effects (n = 41, 16.4%) and dermatologic effects (n = 27, 10.8%). The rate of discontinuation of treatment for patients aged ≥ 65 years was significantly higher than for patients aged < 65 years, for both men (P < 0.0001) and women (P = 0.0121). Moreover, the frequency of discontinuation due to neurovegetative symptoms, depression-related syndrome, and hematologic effects for men aged ≥ 65 years was significantly higher than for those aged < 65 years (P = 0.0001, P = 0.0016, and P = 0.0170, respectively), but not for women.
  
  
  CONCLUSIONS
  Premature discontinuation due to the adverse effects of PEG-IFN α-2b and RBV treatment by patients with chronic HCV infection is mainly due to neuropsychiatric symptoms and is more common for older than for younger patients.
authors.affiliation: Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ogawa
authors.forename: Norihiro
authors.initials: N
authors.lastname: Furusyo
authors.forename: Eiji
authors.initials: E
authors.lastname: Kajiwara
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Takahashi
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Nomura
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Tanabe
authors.forename: Takeaki
authors.initials: T
authors.lastname: Satoh
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Maruyama
authors.forename: Makoto
authors.initials: M
authors.lastname: Nakamuta
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kotoh
authors.forename: Koichi
authors.initials: K
authors.lastname: Azuma
authors.forename: Kazufumi
authors.initials: K
authors.lastname: Dohmen
authors.forename: Shinji
authors.initials: S
authors.lastname: Shimoda
authors.forename: Jun
authors.initials: J
authors.lastname: Hayashi
mesh_terms: D000328:Adult; D000367:Age Factors; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D006402:Hematologic Diseases / Q000139:chemically induced; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012737:Sex Factors
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b