title: Efficacy and tolerability of pegylated interferon-α-2a in chronic hepatitis B: a multicenter clinical experience.
abstract: OBJECTIVE
  Pegylated interferon-α (PEG-IFN) provides potential advantages over nucleos(t)ide analogues in the treatment of chronic hepatitis B (CHB) given its finite course, durability and lack of drug resistance. Much of the evidence is derived from controlled studies and it is unclear whether these results can be replicated in an everyday, non-controlled setting. The aim of this study was to examine the efficacy and tolerability of PEG-IFN-α2A in CHB patients in a clinical setting.
  
  
  METHODS
  Chronic hepatitis B patients treated with PEG-IFN-α2A (180µg/week, 48 weeks) at five tertiary hospitals were retrospectively identified. Baseline demographic and clinical data, on-treatment virological and serological responses and adverse events (AE) were recorded. Treatment outcomes were defined as alanine aminotransferase (ALT) normalization, hepatitis B virus DNA <351 IU/mL and hepatitis B e antigen (HBeAg) seroconversion.
  
  
  RESULTS
  Sixty three HBeAg positive patients were identified (65% male, 80% born in Asia, 84% with viral loads > 6log IU/mL, 9.5% advanced fibrosis). Six months after therapy 46% achieved normalization of ALT, 16% had viral loads < 351 IU/mL and 32% achieved HBeAg seroconversion. 29 HBeAg negative patients were treated (75% male, 86% born in Asia, 48% had viral loads > 6log IU/mL, 24% advanced fibrosis). Six months post-treatment, 55% and 36% maintained a normalized ALT and HBV DNA < 351 IU/mL, respectively. Optimal viral suppression was maintained in 50-75% of patients over 2 years of follow up. 6.5% of all patients discontinued therapy due to AEs.
  
  
  CONCLUSIONS
  In everyday clinical practice PEG-IFN therapy in CHB is well tolerated and can achieve a similar efficacy to that seen in large controlled trials.
authors.affiliation: Gastroenterology and Hepatology Unit, Monash Medical Centre, Australia Department of Medicine, Monash University, Clayton, Australia. dilip.ratnam@monash.edu
authors.forename: Dilip
authors.initials: D
authors.lastname: Ratnam
authors.forename: Anouk
authors.initials: A
authors.lastname: Dev
authors.forename: Tin
authors.initials: T
authors.lastname: Nguyen
authors.forename: Vijaya
authors.initials: V
authors.lastname: Sundararajan
authors.forename: Hugh
authors.initials: H
authors.lastname: Harley
authors.forename: Wendy
authors.initials: W
authors.lastname: Cheng
authors.forename: Alice
authors.initials: A
authors.lastname: Lee
authors.forename: Ferry
authors.initials: F
authors.lastname: Rusli
authors.forename: Robert
authors.initials: R
authors.lastname: Chen
authors.forename: Sally
authors.initials: S
authors.lastname: Bell
authors.forename: Stephen
authors.initials: S
authors.lastname: Pianko
authors.forename: William
authors.initials: W
authors.lastname: Sievert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a