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Entecavir plus tenofovir combination therapy in patients with multidrug-resistant chronic hepatitis B: results of a multicentre, prospective study.

Authors
 Jun Yong Park  ;  Chang Wook Kim  ;  Si Hyun Bae  ;  Kyu Sik Jung  ;  Hee Yeon Kim  ;  Seung Kew Yoon  ;  Kwang-Hyub Han  ;  Sang Hoon Ahn 
Citation
 LIVER INTERNATIONAL, Vol.36(8) : 1108-1115, 2016 
Journal Title
LIVER INTERNATIONAL
ISSN
 1478-3223 
Issue Date
2016
MeSH
Adult ; Antiviral Agents/administration & dosage* ; DNA, Viral/blood ; Drug Administration Schedule ; Drug Resistance, Multiple, Viral/drug effects ; Drug Therapy, Combination ; Female ; Guanine/administration & dosage ; Guanine/analogs & derivatives* ; Hepatitis B virus/drug effects ; Hepatitis B virus/genetics ; Hepatitis B, Chronic/drug therapy* ; Humans ; Male ; Middle Aged ; Prospective Studies ; Republic of Korea ; Tenofovir/administration & dosage* ; Treatment Outcome
Keywords
chronic hepatitis B ; combination therapy ; entecavir ; multidrug resistant ; tenofovir
Abstract
BACKGROUND & AIMS: Sequential therapy posed a high risk of emergence of multidrug resistance and presented a management issue in chronic hepatitis B (CHB) treatment. We evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients.
METHODS: In this prospective, multicentre study, MDR CHB patients, defined as measurable serum HBV DNA (≥60 IU/ml) while on any rescue treatment regimen for at least 24 weeks and the presence of documented prior genotypic resistance to both nucleoside analogue(s) and nucleotide analogue, were treated with ETV 1.0 mg and TDF 300 mg combination therapy for 48 weeks.
RESULTS: A total of 64 eligible patients who had previously failed to a median three lines of antiviral therapy (range, 2-6) were included. At baseline, median age was 47.0 years, 89.1% were HBeAg(+), and median HBV DNA was 4.24 (range, 2.11-6.73) log10 IU/ml. By week 4, 12, 24 and 48, 15/64 (23.4%), 36/64 (56.3%), 43/64 (67.2%) and 55/64 (85.9%) patients achieved a HBV DNA <60 IU/ml respectively. The mean reduction of HBV DNA from baseline to 4 and 48 weeks was 1.23 log10 IU/ml and 2.38 log10 IU/ml respectively. Although five patients experienced virological breakthrough, all were transient and no resistant mutation to TDF or novel mutation was detected in any patients.
CONCLUSIONS: In difficult-to-treat MDR CHB patients with a high exposure to multiple antiviral drugs, ETV plus TDF combination therapy can provide a very high rate of viral suppression through 48 weeks of treatment.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/liv.13059/abstract
DOI
10.1111/liv.13059
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
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
Jung, Kyu Sik(정규식)
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/147165
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