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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

Authors
Chon, Young EunKim, Dong JoonKim, Sang GyuneKim, In HeeBae, Si HyunHwang, Seong GyuHeo, JeongJang, Jeong WonLee, Byung SeokKim, Hyung JoonJun, Dae WonKim, Kang MoChung, Woo JinChoi, Moon SeokJang, Jae YoungYim, Hyung JoonTak, Won YoungYoon, Ki TaePark, Jun YongHan, Kwang-HyubSuk, Ki TaeLee, Hyun WoongJang, Byoung KukAhn, Sang Hoon
Issue Date
4월-2016
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Citation
MEDICINE, v.95, no.14
Indexed
SCIE
SCOPUS
Journal Title
MEDICINE
Volume
95
Number
14
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/89061
DOI
10.1097/MD.0000000000003026
ISSN
0025-7974
Abstract
Currently, limited data are available regarding the efficacy and safety of pegylated interferon alpha-2a (PEG-IFN alpha-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 alpha-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 alpha-2a for 48 weeks showed significantly higher HBV DNA suppression (HBV DNA<2000IU/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 alpha-2a. In naive Korean HBeAg-positive CHB patients treated with PEG-IFN alpha-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.
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