Undetectable HBV DNA at month 12 of entecavir treatment predicts maintained viral suppression and HBeAg-seroconversion in chronic hepatitis B patients at 3 years

Alimentary Pharmacology and Therapeutics, 04/27/2012

Month 12 hepatitis B virus (HBV) DNA responses could predict the probability of maintained virological suppression, HBeAg–seroconversion and risk of drug resistance among patients on entecavir treatment at 3 years.

Methods

  • This was a retrospective cohort study among nucleos(t)ide analogue-naïve HBV-infected patients on entecavir with a minimum follow-up of 2 years.
  • Maintained virological suppression was defined as undetectable HBV DNA (<20 IU/mL) until the last visit.
  • Genotypic drug resistance was screened by using the INNO-LiPA DR assay.

Results

  • A total of 440 chronic hepatitis B patients (160 HBeAg-positive) followed for 34 ± 9 months were included.
  • The cumulative probability of maintained virological suppression at year 1, 2 and 3 were 76.5%, 83.0% and 88.3% respectively.
  • On multivariate analysis, lower baseline HBV DNA, undetectable HBV DNA at month 12 and negative HBeAg were the independent predictors of maintained virological suppression.
  • M12 responders (who had undetectable HBV DNA at month 12) had higher probability of maintained virological suppression at 3 years (99.1%) as compared to non responders (57.5%; P < 0.001).
  • The cumulative probability of HBeAg-seroconversion at year 1, 2 and 3 were 19.0%, 27.2% and 33.5% respectively.
  • M12 responders had higher probability of HBeAg-seroconversion at 3 years (43.2%) than the non responders (19.0%; P = 0.003).
  • M12 responders had lower probability of drug resistance at 3 years (0%) than the non responders (2.6%; P = 0.004).

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