PMID- 29228519
OWN - NLM
STAT- MEDLINE
DCOM- 20190301
LR  - 20220408
IS  - 2005-6648 (Electronic)
IS  - 1226-3303 (Print)
IS  - 1226-3303 (Linking)
VI  - 33
IP  - 1
DP  - 2018 Jan
TI  - Large-scale surveillance study of the safety and effectiveness of entecavir in 
      Korean patients with chronic hepatitis B.
PG  - 91-101
LID - 10.3904/kjim.2016.111 [doi]
AB  - BACKGROUND/AIMS: Entecavir (ETV) is effective and safe antiviral agent against 
      hepatitis B virus (HBV) in clinical and real-world setting but, most studies were 
      performed in single institute or have limitation in patient's number. A 
      large-scale nation-wide real-world surveillance study was carried out to 
      investigate safety, efficacy and clinical effectiveness of ETV in Korean patients 
      with chronic hepatitis B (CHB). METHODS: Between 2006 and 2012, 3,444 patients 
      were enrolled from 132 Korean institutions. For the safety assessment, 
      investigators recorded the occurrence of observed and patient-reported adverse 
      events (AEs), as well as laboratory abnormalities. Efficacy, which consisted of 
      change in HBV DNA and alanine aminotransferase (ALT), was evaluated in patients 
      who had received at least 16 weeks of ETV treatment. Overall clinical 
      effectiveness, based on improvement of ALT, HBV DNA and patient's symptoms, was 
      evaluated by physicians. RESULTS: Of the patients, 3,367 were evaluated for 
      safety and 3,115 for efficacy and clinical effectiveness. Three hundred and 
      eighty AEs were reported in 255 cases (7.57%), and 67 adverse drug reactions in 
      54 cases (1.6%). Serious AEs (SAE) were 19 events in nine cases (0.27%). Serious 
      adverse drug reactions (SADR) were three events in two cases (0.06%), and 
      unexpected SAE/SADR were three events in two cases (0.06%). Medical history and 
      concomitant medications were factors inf luencing incidence rates of AEs. Overall 
      clinical effectiveness rate was 96.53%, which was clinically assessed as marked 
      improved or improved state. CONCLUSIONS: This study showed that ETV was well 
      tolerated and clinically effective in Korean patients with CHB in a real-world 
      nation-wide setting.
FAU - Kim, Chang Wook
AU  - Kim CW
AD  - Department of Internal Medicine, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Kim, Chang Seop
AU  - Kim CS
AD  - Neane Clinic, Seoul, Korea.
FAU - Kim, Hee Yeon
AU  - Kim HY
AD  - Department of Internal Medicine, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Lee, Chang Don
AU  - Lee CD
AD  - Department of Internal Medicine, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Yu, Kyungha
AU  - Yu K
AD  - Bristol-Myers Squibb, Seoul, Korea.
FAU - Llamoso, Cyril
AU  - Llamoso C
AD  - Bristol-Myers Squibb, Wallingford, CT, USA.
FAU - Lee, Heon Ju
AU  - Lee HJ
AD  - Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, 
      Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171213
PL  - Korea (South)
TA  - Korean J Intern Med
JT  - The Korean journal of internal medicine
JID - 8712418
RN  - 0 (Antiviral Agents)
RN  - 0 (DNA, Viral)
RN  - 0 (Hepatitis B e Antigens)
RN  - 5968Y6H45M (entecavir)
RN  - 5Z93L87A1R (Guanine)
RN  - EC 2.6.1.2 (Alanine Transaminase)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Alanine Transaminase/blood
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - DNA, Viral/analysis
MH  - Female
MH  - Guanine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Hepatitis B e Antigens
MH  - Hepatitis B virus/drug effects/genetics
MH  - Hepatitis B, Chronic/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5768541
OTO - NOTNLM
OT  - Drug-related side effects and adverse reactions
OT  - Entecavir
OT  - Hepatitis B, chronic
OT  - Product surveillance, postmarketing
COIS- This surveillance was sponsored by Bristol-Myers Squibb Korea. Kyungha Yu and 
      Cyril Llamoso are employees of Bristol-Myers Squibb. Others are no conflict of 
      interest relevant to this article.
EDAT- 2017/12/12 06:00
MHDA- 2019/03/02 06:00
PMCR- 2018/01/01
CRDT- 2017/12/12 06:00
PHST- 2016/04/04 00:00 [received]
PHST- 2016/09/03 00:00 [revised]
PHST- 2016/10/15 00:00 [accepted]
PHST- 2017/12/12 06:00 [pubmed]
PHST- 2019/03/02 06:00 [medline]
PHST- 2017/12/12 06:00 [entrez]
PHST- 2018/01/01 00:00 [pmc-release]
AID - kjim.2016.111 [pii]
AID - kjim-2016-111 [pii]
AID - 10.3904/kjim.2016.111 [doi]
PST - ppublish
SO  - Korean J Intern Med. 2018 Jan;33(1):91-101. doi: 10.3904/kjim.2016.111. Epub 2017 
      Dec 13.