Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
Aliment Pharmacol Ther. 2012 Jun;35(11):1326-35. doi: 10.1111/j.1365-2036.2012.05098.x. Epub 2012 Apr 16.
On-treatment monitoring of serum hepatitis B virus (HBV) DNA to guide treatment strategy for patients on entecavir has received little attention.
To investigate the predictive value of on-treatment HBV DNA levels for responses to entecavir.
This was a retrospective cohort study among nucleos(t)ide analogue-naïve HBV-infected patients on entecavir with a minimum follow-up of 2 years. Maintained virological suppression was defined as undetectable HBV DNA (<20 IU/mL) until the last visit. Genotypic drug resistance was screened by using the INNO-LiPA DR assay.
A total of 440 chronic hepatitis B patients (160 HBeAg-positive) followed for 34 ± 9 months were included. The cumulative probability of maintained virological suppression at year 1, 2 and 3 were 76.5%, 83.0% and 88.3% respectively. On multivariate analysis, lower baseline HBV DNA, undetectable HBV DNA at month 12 and negative HBeAg were the independent predictors of maintained virological suppression. M12 responders (who had undetectable HBV DNA at month 12) had higher probability of maintained virological suppression at 3 years (99.1%) as compared to non responders (57.5%; P < 0.001). The cumulative probability of HBeAg-seroconversion at year 1, 2 and 3 were 19.0%, 27.2% and 33.5% respectively. M12 responders had higher probability of HBeAg-seroconversion at 3 years (43.2%) than the non responders (19.0%; P = 0.003). M12 responders had lower probability of drug resistance at 3 years (0%) than the non responders (2.6%; P = 0.004).
Month 12 HBV DNA responses could predict the probability of maintained virological suppression, HBeAg-seroconversion and risk of drug resistance among patients on entecavir treatment at 3 years.
恩替卡韦治疗过程中监测血清乙型肝炎病毒 (HBV) DNA 以指导治疗策略的问题尚未得到充分关注。
研究治疗过程中 HBV DNA 水平对恩替卡韦应答的预测价值。
这是一项在恩替卡韦治疗的初治核苷（酸）类似物耐药的乙型肝炎病毒感染者中进行的回顾性队列研究，随访时间至少 2 年。持续病毒学应答定义为直至最后一次就诊时 HBV DNA 不可检测（<20IU/ml）。采用 INNO-LiPA DR 检测方法筛查基因耐药。
共纳入 440 例慢性乙型肝炎患者（160 例 HBeAg 阳性），随访 34±9 个月。第 1、2 和 3 年时维持病毒学应答的累积概率分别为 76.5%、83.0%和 88.3%。多变量分析显示，基线 HBV DNA 水平较低、治疗 12 个月时 HBV DNA 不可检测和 HBeAg 阴性是维持病毒学应答的独立预测因素。在治疗 12 个月时 HBV DNA 不可检测的 M12 应答者（应答者）在 3 年时维持病毒学应答的可能性更高（99.1%），而非应答者（57.5%）的可能性较低（P<0.001）。第 1、2 和 3 年时 HBeAg 血清学转换的累积概率分别为 19.0%、27.2%和 33.5%。M12 应答者在 3 年时 HBeAg 血清学转换的可能性更高（43.2%），而非应答者的可能性更低（19.0%）（P=0.003）。M12 应答者在 3 年时耐药的可能性更低（0%），而非应答者的可能性更高（2.6%）（P=0.004）。
治疗 12 个月时 HBV DNA 应答可预测恩替卡韦治疗 3 年后患者维持病毒学应答、HBeAg 血清学转换和耐药风险的概率。
