Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B
Dept. of Medicine/석사
Background:The proposed definition of a partial virological response (PVR) to nucleos(t)ide analogue in the 2009 European Association for the Study of the Liver (EASL) guidelines is based on limited evidence, especially in terms of the cut-off hepatitis B virus (HBV) DNA level and the time-point at which to judge it. This study assessed optimal PVR criteria for predicting virologic response (VR) at week 96 in treatment-naïve 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 characteristics curve (AUC) was used to find the optimal time-point, and the Youden index was used to calculate the optimal cut-off HBV DNA level.Results: After 96 weeks of ETV therapy, 139 (79.4%) patients achieved VR. The AUC was significantly greater at week 48 than that at week 24 for predicting VR at week 96 (P=0.023). The optimal cut-off 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 exceeding 35 IU/mL at week 48 is the optimal PVR criteria for predicting non-VR at week 96 in treatment-naïve patients with CHB who are receiving ETV. This study supports the proposed EASL PVR for ETV based on scientific evidence.