title: On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients.
abstract: OBJECTIVE
  We assessed predictors of response in HBeAg-negative chronic hepatitis B patients treated with peginterferon alfa-2a in routine clinical practice.
  
  
  METHODS
  Ninety-five HBeAg-negative patients received peginterferonalfa-2a for 48 weeks and were followed-up for 48 weeks post-treatment. Serum HBsAg and HBV DNA levels were monitored during and after therapy with valid commercial assays. Sustained response (SR) was defined as HBV DNA <2000 IU/ml at study week 96.
  
  
  RESULTS
  Twenty-two patients (23%) achieved SR and nine (9.5%) lost HBsAg. HBsAg decline was more profound in patients with SR. HBsAg decline ≥10% from baseline to week 24 was significantly associated with SR [81% (17/21) vs 37% (21/57); Odds ratio: 7.286 (2.162-24.552), P = 0.001]. The PARC rule (no decrease in HBsAg and <2 log drop in HBV DNA at week 12) was evaluated in a subset of 47 patients. Among eight patients who fulfilled the PARC rule, none achieved SR. Of the 39 patients who did not fulfil the PARC rule, 24 (62%) had HBsAg decline of ≥10% at week 24 (12 achieved SR) and 15 (38%) had HBsAg decline of <10% (1 achieved SR; negative predictive value: 93%).
  
  
  CONCLUSIONS
  In HBeAg-negative chronic hepatitis B patients treated with peginterferon alfa-2a, HBsAg decline >10% at 24 weeks is significantly associated with SR. The combination of the PARC rule and week 24 decline in HBsAg can identify almost two-thirds of patients who are unlikely to achieve SR. Clinicaltrials.gov identifier: NCT01283074.
authors.affiliation: 4th Department of Internal Medicine, Αristotle University of Thessaloniki Medical School, Hippokration General Hospital, Thessaloniki, Greece.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Goulis
authors.forename: Stylianos
authors.initials: S
authors.lastname: Karatapanis
authors.forename: Evangelos
authors.initials: E
authors.lastname: Akriviadis
authors.forename: Melanie
authors.initials: M
authors.lastname: Deutsch
authors.forename: George N
authors.initials: GN
authors.lastname: Dalekos
authors.forename: Maria
authors.initials: M
authors.lastname: Raptopoulou-Gigi
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Mimidis
authors.forename: George
authors.initials: G
authors.lastname: Germanidis
authors.forename: Christos
authors.initials: C
authors.lastname: Drakoulis
authors.forename: Christos
authors.initials: C
authors.lastname: Triantos
authors.forename: Elias
authors.initials: E
authors.lastname: Zintzaras
authors.forename: Georgios
authors.initials: G
authors.lastname: Bakalos
authors.forename: George
authors.initials: G
authors.lastname: Papatheodoridis
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a
keywords: HBeAg-negative; HBsAg quantification; chronic hepatitis B; peginterferon; prediction; sustained response; treatment