title: An Observational, Multicenter, Cohort Study Evaluating the Antiviral Efficacy and Safety in Korean Patients With Chronic Hepatitis B Receiving Pegylated Interferon-alpha 2a (Pegasys): TRACES Study.
abstract: Currently, limited data are available regarding the efficacy and safety of pegylated interferon alpha-2a (PEG-IFN α-2a) in Korean patients with chronic hepatitis B (CHB), in whom hepatitis B virus (HBV) genotype C is the most common type.We collected data from 439 patients (HBeAg positive, n = 349; HBeAg negative, n = 90) with CHB who were treated with PEG-IFN α-2a as a first-line therapy from 18 institutions. Treatment responses at the end of treatment (ET) and at 6 months posttreatment (PT6) were compared between the patients who were treated for 24 weeks versus 48 weeks, and adverse events (AEs) were evaluated.In HBeAg-positive patients, those who received PEG-IFN α-2a for 48 weeks showed significantly higher HBV DNA suppression (HBV DNA < 2000 IU/mL) than those who were treated for 24 weeks (48 weeks vs 24 weeks; at ET, 44.4% vs 36.7%, P = 0.035; at PT6, 35.9% vs 13.3%, P = 0.035). The HBeAg seroconversion rate at ET was 18.1% in 48-week treatment group, which is significantly higher than the 2.2% (P < 0.001) that was seen in 24-week treatment group. This finding also continued at PT6 (29.0% vs 10.0%, P < 0.001). Following 48 weeks of treatment in HBeAg-negative patients, HBV DNA suppression at ET was higher than in HBeAg-positive patients (87.8% vs 44.4%). AEs were typical of those associated with PEG-IFN α-2a.In naïve Korean HBeAg-positive CHB patients treated with PEG-IFN α-2a, higher rates of HBV DNA suppression and HBeAg seroconversion were achieved in the 48-week treatment group than in the 24-week treatment group without additional risk of AEs.
authors.affiliation: From the Yonsei University College of Medicine (YEC, JYP, K-HH, SHA), The Catholic University College of Medicine (SHB), Chung-Ang University College of Medicine (HJK, HWL), Hanyang University College of Medicine (DWJ), University of Ulsan College of Medicine (KMK), Sungkyunkwan University College of Medicine (MSC), Soonchunhyang University College of Medicine, Seoul (JYJ), Hallym University College of Medicine, Chuncheon (DJK, KTS), Soonchunhyang University College of Medicine, Bucheon (SGK), Chonbuk National University College of Medicine, Jeonju (IHK), Cha University College of Medicine, Seongnam (SGH), Pusan National University School of Medicine, Busan (JH), The Catholic University College of Medicine, Incheon (JWJ), Chungnam National University College of Medicine, Daejeon (BSL), Keimyung University College of Medicine (WJC, BKJ), Kyungpook National University College of Medicine, Daegu (WYT), Korea University College of Medicine, Ansan (HJY), Pusan National University School of Medicine (KTY), Yangsan, Korea.
authors.forename: Young Eun
authors.initials: YE
authors.lastname: Chon
authors.forename: Dong Joon
authors.initials: DJ
authors.lastname: Kim
authors.forename: Sang Gyune
authors.initials: SG
authors.lastname: Kim
authors.forename: In Hee
authors.initials: IH
authors.lastname: Kim
authors.forename: Si Hyun
authors.initials: SH
authors.lastname: Bae
authors.forename: Seong Gyu
authors.initials: SG
authors.lastname: Hwang
authors.forename: Jeong
authors.initials: J
authors.lastname: Heo
authors.forename: Jeong Won
authors.initials: JW
authors.lastname: Jang
authors.forename: Byung Seok
authors.initials: BS
authors.lastname: Lee
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Kim
authors.forename: Dae Won
authors.initials: DW
authors.lastname: Jun
authors.forename: Kang Mo
authors.initials: KM
authors.lastname: Kim
authors.forename: Woo Jin
authors.initials: WJ
authors.lastname: Chung
authors.forename: Moon Seok
authors.initials: MS
authors.lastname: Choi
authors.forename: Jae Young
authors.initials: JY
authors.lastname: Jang
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Yim
authors.forename: Won Young
authors.initials: WY
authors.lastname: Tak
authors.forename: Ki Tae
authors.initials: KT
authors.lastname: Yoon
authors.forename: Jun Yong
authors.initials: JY
authors.lastname: Park
authors.forename: Kwang-Hyub
authors.initials: KH
authors.lastname: Han
authors.forename: Ki Tae
authors.initials: KT
authors.lastname: Suk
authors.forename: Hyun Woong
authors.initials: HW
authors.lastname: Lee
authors.forename: Byoung Kuk
authors.initials: BK
authors.lastname: Jang
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a