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Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients.

AbstractBACKGROUND & AIMS:
We determined the antiviral potency and viral resistance rate after 4 years of continuous entecavir treatment in patients with chronic hepatitis B (CHB) infection.
METHODS:
The cumulative rates of undetectable hepatitis B virus DNA (HBV DNA;<2.6 log(10) copies/ml), hepatitis B e antigen (HBeAg) seronegativity, seroconversion, alanine aminotransferase (ALT) normalization, and entecavir signature mutations were calculated in 474 nucleos(t)ide-naïve CHB patients (HBeAg-positive: 47%) on continuous entecavir treatment for 4 years.
RESULTS:
Median age was 47 years and follow-up period was 2.4 years, with 403, 281, 165, and 73 patients followed-up for at least 1, 2, 3, and 4 years, respectively. Incremental increases were observed in the rates of undetectable HBV DNA, HBeAg seroclearance and seroconversion, and ALT normalization, reaching 96%, 42%, 38% and 93%, respectively, by the fourth year. In all, 100% and 93% of patients negative and positive for HBeAg, respectively, had undetectable HBV DNA at year 4. Of 165 patients, HBV DNA was detectable in nine patients after 3 years. Multivariate analysis identified HBV DNA level (≤7.6 log(10) copies/ml, OR=15.8; 95% CI=43.1-79.9, P=0.001) as an independent predictor of undetectable HBV DNA at year 3. Five patients experienced virological breakthrough including two (0.4%) who developed entecavir-resistance mutations.
CONCLUSIONS:
Continuous treatment of nucleos(t)ide-naïve CHB patients with entecavir over 4 years was associated with 96% chance of undetectable HBV DNA and only 0.4% chance of emerging entecavir-resistant mutations.
AuthorsAtsushi Ono, Fumitaka Suzuki, Yusuke Kawamura, Hitomi Sezaki, Tetsuya Hosaka, Norio Akuta, Masahiro Kobayashi, Yoshiyuki Suzuki, Satoshi Saitou, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, Sachiyo Watahiki, Rie Mineta, Hiromitsu Kumada
JournalJournal of hepatology (J Hepatol) Vol. 57 Issue 3 Pg. 508-14 (Sep 2012) ISSN: 1600-0641 [Electronic] Netherlands
PMID22659518 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Chemical References
  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B e Antigens
  • entecavir
  • Guanine
  • Alanine Transaminase
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Alanine Transaminase (blood)
  • Antiviral Agents (therapeutic use)
  • Confidence Intervals
  • DNA, Viral (blood)
  • Drug Resistance, Viral
  • Female
  • Genotype
  • Guanine (analogs & derivatives, therapeutic use)
  • Hepatitis B e Antigens (blood)
  • Hepatitis B virus (genetics)
  • Hepatitis B, Chronic (blood, drug therapy)
  • Humans
  • Kaplan-Meier Estimate
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Mutation
  • Odds Ratio
  • Retrospective Studies
  • Time Factors
  • Young Adult

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