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Management of Clevudine-Resistant Chronic Hepatitis B: A Multicenter Cohort Study

 Eun Young Cho  ;  Hyung Joon Yim  ;  Young Kul Jung  ;  Sang Jun Suh  ;  Yeon Seok Seo  ;  Ji Hoon Kim  ;  Hong Soo Kim  ;  Sae Hwan Lee  ;  Sang Hoon Ahn  ;  Jeong Il Lee  ;  Sook-Hyang Jeong  ;  Jin-Wook Kim  ;  Jin-Woo Lee  ;  In Hee Kim  ;  Hyoung Su Kim  ;  Sang Jong Park  ;  Jeong Mi Lee  ;  Seong Gyu Hwang  ;  on behalf of Antiviral Resistance Study Group 
 GUT AND LIVER, Vol.11(1) : 129-135, 2017 
Journal Title
Issue Date
Adenine/analogs & derivatives* ; Adenine/therapeutic use ; Adult ; Aged ; Antiviral Agents/therapeutic use* ; Arabinofuranosyluracil/analogs & derivatives* ; Arabinofuranosyluracil/therapeutic use ; Cohort Studies ; DNA, Viral/blood ; Disease Management ; Drug Resistance, Viral/genetics ; Drug Therapy, Combination ; Female ; Genotype ; Guanine/analogs & derivatives* ; Guanine/therapeutic use ; Hepatitis B virus/genetics ; Hepatitis B, Chronic/blood ; Hepatitis B, Chronic/drug therapy* ; Hepatitis B, Chronic/virology ; Humans ; Lamivudine/therapeutic use* ; Male ; Middle Aged ; Organophosphonates/therapeutic use* ; Viral Load
Clevudine ; Hepatitis B, chronic ; Resistance ; Therapy
Background/Aims: Data are lacking regarding the management of chronic hepatitis B (CHB) with resistance to clevudine (CLV). This study evaluated the efficacy of different rescue therapies for CLV-resistant CHB.

Methods: Patients with CLV-resistant CHB were enrolled in the cohort, and all patients developed virologic breakthrough during CLV therapy and had confirmed-genotypic resistance to CLV (rtM204I mutation) before enrollment.

Results: Of the 107 patients, 12 received adefovir (ADV), 21 received a CLV plus ADV combination (CLV+ADV), 34 received a lamivudine plus ADV combination (LAM+ADV), and 40 received entecavir (ETV) therapy for 48 weeks. The CLV+ADV group had the lowest hepatitis B virus (HBV) DNA level (p<0.0001) and showed the greatest reduction of HBV DNA levels from baseline compared to all other groups (p=0.004) at week 48. HBV DNA was undetectable (<70 IU/mL) in 0%, 57.1%, 21.2%, and 27.5% (p=0.003) of the patients in each group, respectively, at week 48. At the end of the study, the mean alanine transaminase (ALT) level, rate of ALT normalization, and rate of hepatitis B envelope antigen loss or seroconversion did not differ between groups.

Conclusions: CLV+ADV combination therapy in patients with CLV-resistant CHB more effectively suppresses HBV replication than ETV, ADV, or LAM+ADV therapy.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Jung Il(이정일) ORCID logo https://orcid.org/0000-0002-0142-1398
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