title: Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a.
abstract: OBJECTIVE
  Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB).
  
  
  METHODS
  The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 microg peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed throughout the treatment period. A 24-week treatment-free follow-up period was also included.
  
  
  RESULTS
  Differences (HBV vs HCV) were observed in the incidence of AEs (88-89 vs 96-100%), serious AEs (4-5 vs 7-16%) and treatment withdrawals (6-8 vs 17-33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P<0.001), as was the impact of treatment on HRQL.
  
  
  CONCLUSIONS
  The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression.
authors.affiliation: Service d'Hépatologie & INSERM CRB3, University of Paris, Hôpital Beaujon, Clichy, France. patrick.marcellin@bjn.ap-hop-paris.fr
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: George K K
authors.initials: GK
authors.lastname: Lau
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: E Jenny
authors.initials: EJ
authors.lastname: Heathcote
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.forename: Teerha
authors.initials: T
authors.lastname: Piratvisuth
authors.forename: Patrizia
authors.initials: P
authors.lastname: Farci
authors.forename: Wan-Cheng
authors.initials: WC
authors.lastname: Chow
authors.forename: Ji-Dong
authors.initials: JD
authors.lastname: Jia
authors.forename: Woon
authors.initials: W
authors.lastname: Paik
authors.forename: Neil
authors.initials: N
authors.lastname: Wintfeld
authors.forename: Nigel
authors.initials: N
authors.lastname: Pluck
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008111:Liver Function Tests; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011336:Probability; D011379:Prognosis; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a