Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Digestion. 2013;87(3):196-203. doi: 10.1159/000348853. Epub 2013 May 9.
BACKGROUND/AIMS: In patients with lamivudine (LAM)-resistant chronic hepatitis B (CHB) receiving adefovir (ADV) add-on LAM therapy, insufficient viral suppression or the appearance of additional ADV resistance has remained unresolved. This study determined the partial virological response (PVR) criteria to predict a virological response (VR) at week 96 in these patients.
96 patients with LAM-resistant CHB (ADV add-on LAM therapy >2 years) were analyzed. For predicting VR at week 96, the area under the receiver operating characteristic curve values at different time points were compared to establish the optimal time point, and the maximal Youden index was calculated to determine the optimal cut-off hepatitis B virus (HBV) DNA level.
50 (52.1%) patients achieved VR at 2 years after ADV add-on LAM therapy. The optimal PVR criteria were determined to be HBV DNA 500 IU/ml at week 48. 44 (45.8%) patients who met optimal PVR criteria showed a significantly higher risk for detectable HBV DNA levels at week 96 than those with a favorable VR (HBV DNA <500 IU/ml) at week 48.
This study suggested optimal PVR criteria in patients with LAM-resistant CHB receiving ADV add-on LAM therapy. Modification of the antiviral agent regimen should be considered if the serum HBV DNA level exceeds 500 IU/ml at week 48.
背景/目的：在接受阿德福韦酯（ADV）加用拉米夫定（LAM）治疗的 LAM 耐药慢性乙型肝炎（CHB）患者中，病毒抑制不足或出现额外的 ADV 耐药性仍然没有得到解决。本研究确定了部分病毒学应答（PVR）标准，以预测这些患者在第 96 周的病毒学应答（VR）。
分析了 96 例 LAM 耐药 CHB（ADV 加用 LAM 治疗>2 年）患者。为了预测第 96 周的 VR，比较了不同时间点的受试者工作特征曲线下面积值，以确定最佳时间点，并计算最大 Youden 指数，以确定最佳 HBV DNA 水平截断值。
50 例（52.1%）患者在 ADV 加用 LAM 治疗 2 年后获得 VR。确定的最佳 PVR 标准为第 48 周时 HBV DNA 500 IU/ml。44 例（45.8%）符合最佳 PVR 标准的患者在第 96 周时 HBV DNA 可检测到的风险明显高于第 48 周时具有良好 VR（HBV DNA <500 IU/ml）的患者。
本研究建议在接受 ADV 加用 LAM 治疗的 LAM 耐药 CHB 患者中采用最佳 PVR 标准。如果第 48 周时血清 HBV DNA 水平超过 500 IU/ml，应考虑修改抗病毒药物方案。
