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
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Antivir Ther. 2011;16(4):469-77. doi: 10.3851/IMP1772.
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).
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.
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).
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.
2009年欧洲肝脏研究协会（EASL）指南中提出的对核苷（酸）类似物治疗的部分病毒学应答（PVR）定义所依据的证据有限，尤其是在HBV DNA水平临界值以及判断时间点方面。本研究评估了在初治慢性乙型肝炎（CHB）患者中接受恩替卡韦（ETV）治疗时预测第96周病毒学应答（VR）的最佳PVR标准。
前瞻性招募了175例完成96周一线ETV治疗的患者（126例男性，49例女性）。为预测第96周的VR，采用受试者操作特征曲线下面积（AUC）来确定最佳时间点，并使用约登指数计算最佳HBV DNA水平临界值。
ETV治疗96周后，139例（79.4%）患者实现了VR。在预测第96周的VR时，第48周的AUC显著优于第24周（P = 0.023）。第48周的最佳HBV DNA水平临界值为35 IU/ml。41例（23.4%）患者符合ETV的这一PVR标准（第48周时HBV DNA水平>35 IU/ml）。
对于接受ETV治疗的初治CHB患者，第48周时HBV DNA水平>35 IU/ml是预测第96周非VR的最佳PVR标准。本研究为EASL提出的基于科学证据的ETV的PVR提供了支持。
