title: Long-term follow up of peginterferon-α-2a treatment of hepatitis B e-antigen (HBeAg) positive and HBeAg negative chronic hepatitis B patients in phase II and III studies.
abstract: OBJECTIVE
  We analyzed the 5-year post-treatment response to peginterferon α-2a (PEG IFN-α-2a) in hepatitis B e-antigen (HBeAg) positive and negative chronic hepatitis B patients.
  
  
  METHODS
  One hundred and thirty-seven chronic hepatitis B (CHB) patients receiving 90 μg or 180 μg of PEG IFN-α-2a for 24 or 48 weeks in phase II or III studies were enrolled in the study, including 100 HBeAg positive patients and 37 HBeAg negative patients; 121 patients (88.4%) had genotype C.
  
  
  RESULTS
  Of the 137 patients, 94 received additional antiviral therapy because of viral reactivation and 43 did not receive any additional antiviral treatment during follow up. Five years upon PEG IFN-α-2a treatment, 32 patients (23.4%) who did not receive any additional antiviral agent after PEG IFN-α-2a therapy achieved a good response (normal serum alanine aminotransferase, low-level hepatitis B virus [HBV] DNA, and HBeAg negativity). Female sex and low HBV DNA levels by the end of treatment were independently associated with favorable 5-year post-treatment responses. Forty-eight-week administration of PEG IFN-α-2a showed a better response (26.4%) than 24-week administration (18.0%). Six patients (4.3%), four males and two females, cleared hepatitis B surface antigen (HBsAg) during the 5-year follow-up period.
  
  
  CONCLUSIONS
  The 48-week administration of PEG IFN-α-2a achieved better biochemical and virological responses than the 24-week administration, particularly in younger females. The 5-year post-treatment response rate was 23.4%; however, more than two-thirds of the patients received additional antiviral therapy because of viral reactivation after PEG IFN-α-2a treatment. HBsAg clearance was noted in six patients (4.3%). PEG IFN-α-2a is effective in young female patients.
authors.affiliation: Center of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Okanoue
authors.affiliation: Center of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
authors.forename: Toshihide
authors.initials: T
authors.lastname: Shima
authors.affiliation: Department of Gastroenterology, Asahikawa Red Cross Hospital, Asahikawa, Japan.
authors.forename: Chitomi
authors.initials: C
authors.lastname: Hasebe
authors.affiliation: Department of Hepatology, Sapporo Kohseiren Hospital, Sapporo, Japan.
authors.forename: Yoshiyasu
authors.initials: Y
authors.lastname: Karino
authors.affiliation: Department of Gastroenterology and Nephrology, Chiba University, Chiba, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Imazeki
authors.affiliation: Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kumada
authors.affiliation: Department of Gastroenterology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Minami
authors.affiliation: Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda, Japan.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Imai
authors.affiliation: Department of Gastroenterology, Osaka Rousai Hospital, Sakai, Japan.
authors.forename: Harumasa
authors.initials: H
authors.lastname: Yoshihara
authors.affiliation: Department of Gastroenterology, National Hospital Organization Osaka Medical Center, Osaka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Mita
authors.affiliation: Department of Hepatology, Akashi Municipal Hospital, Akashi, Japan.
authors.forename: Teruhisa
authors.initials: T
authors.lastname: Morikawa
authors.affiliation: Division of Hepatobiliary and Pancreatic Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Shuhei
authors.initials: S
authors.lastname: Nishiguchi
authors.affiliation: Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
authors.forename: Yoshiiku
authors.initials: Y
authors.lastname: Kawakami
authors.affiliation: Hepatology Center, Shin-Kokura Hospital, Kitakyushu, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Nomura
authors.affiliation: Department of Gastroenterolgy, Fukuoka University, Fukuoka, Japan.
authors.forename: Shotaro
authors.initials: S
authors.lastname: Sakisaka
authors.affiliation: Department of Gastroenterology, Musashino Red Cross Hospital, Musashino, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kurosaki
authors.affiliation: Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yatsuhashi
authors.affiliation: Department of Gastroenterology and Life Style-Related Disease, Kagoshima University, Kagoshima, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Oketani
authors.affiliation: Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, Kure, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kohno
authors.affiliation: Department of Hepatology, Aso Iizuka Hospital, Iizuka, Japan.
authors.forename: Akihide
authors.initials: A
authors.lastname: Masumoto
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
keywords: chronic hepatitis B; peginterferon; response; seroconversion