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Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naive chronic hepatitis B patients in Korea: data from the clinical practice setting in a single-center cohort

Authors
 Sung Soo Ahn  ;  Young Eun Chon  ;  Beom Kyung Kim  ;  Seung Up Kim  ;  Do Young Kim  ;  Sang Hoon Ahn  ;  Kwang Hyub Han  ;  Jun Yong Park 
Citation
 CLINICAL AND MOLECULAR HEPATOLOGY, Vol.20(3) : 261-266, 2014 
Journal Title
CLINICAL AND MOLECULAR HEPATOLOGY
ISSN
 2287-2728 
Issue Date
2014
MeSH
Adenine/adverse effects ; Adenine/analogs & derivatives* ; Adenine/therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Alanine Transaminase/blood ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use* ; Cohort Studies ; DNA, Viral/blood ; Female ; Gastrointestinal Diseases/epidemiology ; Gastrointestinal Diseases/etiology ; Hepatitis B e Antigens/blood ; Hepatitis B virus/genetics ; Hepatitis B, Chronic/complications ; Hepatitis B, Chronic/drug therapy* ; Hepatitis B, Chronic/virology ; Humans ; Liver Cirrhosis/etiology ; Male ; Middle Aged ; Organophosphonates/adverse effects ; Organophosphonates/therapeutic use* ; Republic of Korea ; Retrospective Studies ; Tenofovir ; Treatment Outcome ; Young Adult
Keywords
Chronic hepatitis B ; Korean ; Real-life ; Tenofovir
Abstract
Background/Aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naive chronic hepatitis B (CHB) patients. Methods: A total of 411 treatment-naive CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months. Results: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log10 IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8 %, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted. Conclusions: In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naive CHB patients.
DOI
10.3350/cmh.2014.20.3.261
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Kim, Beom Kyung(김범경) ORCID logo https://orcid.org/0000-0002-5363-2496
Kim, Seung Up(김승업) ORCID logo https://orcid.org/0000-0002-9658-8050
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Ahn, Sung Soo(안성수) ORCID logo https://orcid.org/0000-0002-9002-9880
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/99980
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