Abstract

Background & aimsVirological breakthrough (VBT) could be a manifestation of chronic hepatitis B (CHB) in patients treated with long-term nucleot(s)ide analogues. We aimed to determine the association of on-treatment serum hepatitis B virus (HBV) DNA with VBT in HBeAg-positive CHB patients receiving entecavir (ETV) treatment.MethodsA retrospective cohort study, including 162 consecutive patients (95 men and 67 women; mean age, 43.1±13.4 years) with HBeAg-positive CHB treated with ETV for at least 48 weeks between August 2008 and May 2015, was conducted. Univariate and multivariate cox regression analysis were used to identify associations with VBT and clinical factors, including HBV DNA and HBeAg serum status.ResultsAmong the 162 ETV-treated HBeAg-positive CHB patients, eighteen patients (11.1%) experienced VBT (VBT group), whereas the other 144 patients were without VBT (non-VBT group). The cumulative rate of HBV DNA < 100 IU/mL in the VBT group and the non-VBT group at week 48 were 44.44% and 70.14%, and at week 96 were 58.33% and 92.56%, respectively (p = 0.015). The cumulative rate of HBeAg seroclearance in the VBT group and non-VBT group at week 48 and week 96 were statistically significant (p = 0.014). Multivariate analysis disclosed that failure to achieve HBeAg seroclearance were the factors significantly associated with VBT.ConclusionsOur results demonstrated that on-treatment HBV DNA could probably predict VBT in ETV-treated HBeAg-positive chronic hepatitis B patients. Failure to achieve HBeAg seroclearance was associated with VBT in ETV-treated HBeAg-positive CHB patients. HBV DNA >100IU/mL at 48 weeks is potentially a predictor for VBT.

Highlights

  • The standard treatment strategies for chronic hepatitis B (CHB) include lamivudine, adefovir, entecavir (ETV), telbivudine, tenofovir, and pegylated interferon

  • Among the 162 ETV-treated HBeAg-positive CHB patients, eighteen patients (11.1%) experienced Virological breakthrough (VBT) (VBT group), whereas the other 144 patients were without VBT

  • The cumulative rate of hepatitis B virus (HBV) DNA < 100 IU/mL in the VBT group and the non-VBT group at week 48 were 44.44% and 70.14%, and at week 96 were 58.33% and 92.56%, respectively (p = 0.015)

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Summary

Introduction

The standard treatment strategies for chronic hepatitis B (CHB) include lamivudine, adefovir, entecavir (ETV), telbivudine, tenofovir, and pegylated interferon. On-treatment HBV DNA monitoring is associated with the effect of treatment, including HBsAg and HBeAg seroclearance/seroconversion, drug resistance, and determination of cessation long-term NA treatment.[5, 9, 11]. Virological breakthrough (VBT) could be a manifestation of chronic hepatitis B (CHB) in patients treated with long-term nucleot(s)ide analogues. We aimed to determine the association of on-treatment serum hepatitis B virus (HBV) DNA with VBT in HBeAg-positive CHB patients receiving entecavir (ETV) treatment.

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