title: Treatment outcomes and validation of the stopping rule for response to peginterferon in chronic hepatitis B: A Thai nationwide cohort study.
abstract: OBJECTIVE
  Peginterferon has demonstrated effectiveness in clinical trials in patients with chronic hepatitis B (CHB). However, its efficacy in real-life settings remains unclear. We investigated the efficacy of peginterferon for CHB and validated the performance of previously identified response predictors in clinical practice.
  
  
  METHODS
  We analyzed prospectively collected data from a Thai nationwide cohort of CHB patients treated with peginterferon alfa-2a (180 µg/week, 48 weeks).
  
  
  RESULTS
  Among a total of 233 patients, mostly with genotype B or C, sustained response was observed in 23% of 135 hepatitis B e antigen (HBeAg)-positive patients (HBeAg seroconversion with hepatitis B virus [HBV] DNA < 2000 IU/mL) and 42% of 98 HBeAg-negative patients (HBV DNA < 2000 IU/mL with aminotransferase normalization) at 24 weeks after treatment. Age, sex, presence of cirrhosis, genotype, and pretreatment levels of aminotransferase, HBV DNA, and hepatitis B surface antigen (HBsAg) were not identified as significant predictors of sustained response. In HBeAg-positive patients, HBsAg > 20 000 IU/mL at week 12 provided a good stopping rule, with a negative predictive value of 96%. In HBeAg-negative patients, the performance of 12-week stopping rules of no decline in HBsAg with a < 2log10decline in HBV DNA and a < 10% log10decline in HBsAg showed modest negative predictive values of 80% and 66%, respectively, for achieving sustained response.
  
  
  CONCLUSIONS
  Outcomes in CHB patients treated with peginterferon in a clinical setting are similar to those demonstrated in clinical trials. Application of the early stopping rule based on HBsAg quantification may allow individualization of therapy, particularly in HBeAg-positive patients.
authors.affiliation: Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Phunchai
authors.initials: P
authors.lastname: Charatcharoenwitthaya
authors.affiliation: Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Wattana
authors.initials: W
authors.lastname: Sukeepaisarnjaroen
authors.affiliation: Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
authors.forename: Teerha
authors.initials: T
authors.lastname: Piratvisuth
authors.affiliation: Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Satawat
authors.initials: S
authors.lastname: Thongsawat
authors.affiliation: Phramongkutklao Hospital, Bangkok, Thailand.
authors.forename: Theeranun
authors.initials: T
authors.lastname: Sanpajit
authors.affiliation: Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.
authors.forename: Soonthorn
authors.initials: S
authors.lastname: Chonprasertsuk
authors.affiliation: Buddhachinaraj Hospital, Phitsanulok, Thailand.
authors.forename: Woramon
authors.initials: W
authors.lastname: Jeamsripong
authors.affiliation: Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.
authors.forename: Ekawee
authors.initials: E
authors.lastname: Sripariwuth
authors.affiliation: Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Piyawat
authors.initials: P
authors.lastname: Komolmit
authors.affiliation: Police General Hospital, Bangkok, Thailand.
authors.forename: Tanisa
authors.initials: T
authors.lastname: Patcharatrakul
authors.affiliation: BMA Medical College and Vajira Hospital, Bangkok, Thailand.
authors.forename: Rattana
authors.initials: R
authors.lastname: Boonsirichan
authors.affiliation: Rajavithi Hospital, Bangkok, Thailand.
authors.forename: Chalermrat
authors.initials: C
authors.lastname: Bunchorntavakul
authors.affiliation: Bhumibol Adulyadej Hospital, Bangkok, Thailand.
authors.forename: Supoj
authors.initials: S
authors.lastname: Tuntipanichteerakul
authors.affiliation: Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Tawesak
authors.initials: T
authors.lastname: Tanwandee
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000627:therapeutic use; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a
keywords: antiviral therapy; chronic hepatitis B; peginterferon; quantitative HBsAg; stopping rule