Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B

Young Eun Chon, Seung Up Kim, Chun Kyon Lee, Jeong Heo, Ja Kyung Kim, Ki Tae Yoon, Mong Cho, Kwan Sik Lee, Dong Hwan Kim, Eun Hee Choi, Jun Yong Park, Do Young Kim, Chae Yoon Chon, Kwang Hyub Han, Sang Hoon Ahn

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Abstract

Background: The proposed definition of a partial virological response (PVR) to nucleos(t)ide analogue therapy in the 2009 European Association for the Study of the Liver (EASL) guidelines is based on limited evidence, especially in terms of the cutoff HBV DNA level and the time point at which to judge it. This study assessed optimal PVR criteria for predicting virological response (VR) at week 96 in treatment-naive patients with chronic hepatitis B (CHB) receiving entecavir (ETV). Methods: A total of 175 patients (126 men, 49 women) who completed 96 weeks of first-line ETV therapy were prospectively recruited. For predicting VR at week 96, the area under the receiver operating characteristic curve (AUC) was used to find the optimal time point and the Youden index was used to calculate the optimal cutoff HBV DNA level. Results: After 96 weeks of ETV therapy, 139 (79.4%) patients achieved VR. The AUC at week 48 was significantly better than that at week 24 for predicting VR at week 96 (P=0.023). The optimal cutoff HBV DNA level at week 48 was 35 IU/ml. Forty-one (23.4%) patients met this PVR criteria of ETV (HBV DNA level >35 IU/ml at week 48). Conclusions: An HBV DNA level >35 IU/ml at week 48 is the optimal PVR criteria for predicting non-VR at week 96 in treatment-naive patients with CHB who are receiving ETV. This study supports the proposed EASL PVR for ETV based on scientific evidence.

Original languageEnglish
Pages (from-to)469-477
Number of pages9
JournalAntiviral therapy
Volume16
Issue number4
DOIs
Publication statusPublished - 2011 Jun 27

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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    Chon, Y. E., Kim, S. U., Lee, C. K., Heo, J., Kim, J. K., Yoon, K. T., Cho, M., Lee, K. S., Kim, D. H., Choi, E. H., Park, J. Y., Kim, D. Y., Chon, C. Y., Han, K. H., & Ahn, S. H. (2011). Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B. Antiviral therapy, 16(4), 469-477. https://doi.org/10.3851/IMP1772