PMID- 27057828
OWN - NLM
STAT- MEDLINE
DCOM- 20160825
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 95
IP  - 14
DP  - 2016 Apr
TI  - 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.
PG  - e3026
LID - 10.1097/MD.0000000000003026 [doi]
LID - e3026
AB  - 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 < 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 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.
FAU - Chon, Young Eun
AU  - Chon YE
AD  - 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.
FAU - Kim, Dong Joon
AU  - Kim DJ
FAU - Kim, Sang Gyune
AU  - Kim SG
FAU - Kim, In Hee
AU  - Kim IH
FAU - Bae, Si Hyun
AU  - Bae SH
FAU - Hwang, Seong Gyu
AU  - Hwang SG
FAU - Heo, Jeong
AU  - Heo J
FAU - Jang, Jeong Won
AU  - Jang JW
FAU - Lee, Byung Seok
AU  - Lee BS
FAU - Kim, Hyung Joon
AU  - Kim HJ
FAU - Jun, Dae Won
AU  - Jun DW
FAU - Kim, Kang Mo
AU  - Kim KM
FAU - Chung, Woo Jin
AU  - Chung WJ
FAU - Choi, Moon Seok
AU  - Choi MS
FAU - Jang, Jae Young
AU  - Jang JY
FAU - Yim, Hyung Joon
AU  - Yim HJ
FAU - Tak, Won Young
AU  - Tak WY
FAU - Yoon, Ki Tae
AU  - Yoon KT
FAU - Park, Jun Yong
AU  - Park JY
FAU - Han, Kwang-Hyub
AU  - Han KH
FAU - Suk, Ki Tae
AU  - Suk KT
FAU - Lee, Hyun Woong
AU  - Lee HW
FAU - Jang, Byoung Kuk
AU  - Jang BK
FAU - Ahn, Sang Hoon
AU  - Ahn SH
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Antiviral Agents)
RN  - 0 (Hepatitis B e Antigens)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Antiviral Agents/*therapeutic use
MH  - Cohort Studies
MH  - Female
MH  - Hepatitis B e Antigens/blood
MH  - Hepatitis B, Chronic/blood/*drug therapy
MH  - Humans
MH  - Interferon-alpha/*therapeutic use
MH  - Male
MH  - Polyethylene Glycols/*therapeutic use
MH  - Recombinant Proteins/therapeutic use
MH  - Republic of Korea
MH  - Treatment Outcome
PMC - PMC4998744
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2016/04/09 06:00
MHDA- 2016/08/26 06:00
PMCR- 2016/04/08
CRDT- 2016/04/09 06:00
PHST- 2016/04/09 06:00 [entrez]
PHST- 2016/04/09 06:00 [pubmed]
PHST- 2016/08/26 06:00 [medline]
PHST- 2016/04/08 00:00 [pmc-release]
AID - 00005792-201604050-00004 [pii]
AID - 10.1097/MD.0000000000003026 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2016 Apr;95(14):e3026. doi: 10.1097/MD.0000000000003026.