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

Research output: Contribution to journalArticle

12 Citations (Scopus)

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

Fingerprint

Chronic Hepatitis B
DNA
Area Under Curve
Therapeutics
ROC Curve
entecavir
Guidelines
Liver

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Chon, Young Eun ; Kim, Seung Up ; Lee, Chun Kyon ; Heo, Jeong ; Kim, Ja Kyung ; Yoon, Ki Tae ; Cho, Mong ; Lee, Kwan Sik ; Kim, Dong Hwan ; Choi, Eun Hee ; Park, Jun Yong ; Kim, Do Young ; Chon, Chae Yoon ; Han, Kwang Hyub ; Ahn, Sang Hoon. / Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B. In: Antiviral therapy. 2011 ; Vol. 16, No. 4. pp. 469-477.
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title = "Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B",
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.",
author = "Chon, {Young Eun} and Kim, {Seung Up} and Lee, {Chun Kyon} and Jeong Heo and Kim, {Ja Kyung} and Yoon, {Ki Tae} and Mong Cho and Lee, {Kwan Sik} and Kim, {Dong Hwan} and Choi, {Eun Hee} and Park, {Jun Yong} and Kim, {Do Young} and Chon, {Chae Yoon} and Han, {Kwang Hyub} and Ahn, {Sang Hoon}",
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Chon, YE, Kim, SU, Lee, CK, Heo, J, Kim, JK, Yoon, KT, Cho, M, Lee, KS, Kim, DH, Choi, EH, Park, JY, Kim, DY, Chon, CY, Han, KH & Ahn, SH 2011, 'Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B', Antiviral therapy, vol. 16, no. 4, pp. 469-477. https://doi.org/10.3851/IMP1772

Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B. / Chon, Young Eun; Kim, Seung Up; Lee, Chun Kyon; Heo, Jeong; Kim, Ja Kyung; Yoon, Ki Tae; Cho, Mong; Lee, Kwan Sik; Kim, Dong Hwan; Choi, Eun Hee; Park, Jun Yong; Kim, Do Young; Chon, Chae Yoon; Han, Kwang Hyub; Ahn, Sang Hoon.

In: Antiviral therapy, Vol. 16, No. 4, 27.06.2011, p. 469-477.

Research output: Contribution to journalArticle

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T1 - Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B

AU - Chon, Young Eun

AU - Kim, Seung Up

AU - Lee, Chun Kyon

AU - Heo, Jeong

AU - Kim, Ja Kyung

AU - Yoon, Ki Tae

AU - Cho, Mong

AU - Lee, Kwan Sik

AU - Kim, Dong Hwan

AU - Choi, Eun Hee

AU - Park, Jun Yong

AU - Kim, Do Young

AU - Chon, Chae Yoon

AU - Han, Kwang Hyub

AU - Ahn, Sang Hoon

PY - 2011/6/27

Y1 - 2011/6/27

N2 - 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.

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