[Clinical effect of entecavir versus tenofovir in treatment of HBeAg-positive chronic hepatitis B patients with a high viral load: a comparative analysis].

Objective: To investigate the clinical effect and safety of entecavir (ETV) versus tenofovir disoproxil fumarate (TDF) in the treatment of previously untreated HBeAg-positive chronic hepatitis B (CHB) patients with a high viral load. Methods: A retrospective analysis was performed for the clinical data of 152 HBeAg-positive CHB patients with a high viral load (HBV DNA≥10(6) IU/ml) who were firstly treated with ETV (ETV group) or TDF (TDF group), with 76 patients in each group. The serum levels of alanine aminotransferase (ALT), HBV DNA, HBeAg, anti-HBe, creatinine, and creatine kinase were measured at baseline, and the patients were followed up and evaluated at weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 of treatment. The Kaplan-Meier survival curves were used to analyze cumulative complete virologic response, HBeAg seroconversion, and ALT normalization rate. The Cox proportional hazards regression model was used to identify the influencing factors for virologic response. P < 0.05 was considered statistically significant. Results: There were no significant differences in ALT normalization rate between the ETV group and the TDF group at weeks 4, 12, 24, 48, 72, and 96 of treatment (18.1%/55.6%/83.3%/90.3%/93.1%/97.2% vs 16.0%/53.6%/75.4%/94.2%/100%/100%, P > 0.05). There were also no significant differences in virologic response rate between the ETV group and the TDF group at weeks 48 and 96 of treatment (89.5%/97.3% vs 93.4%/98.7%, P > 0.05). The multivariate analysis showed that the baseline parameters were not predictive factors for virologic response. At week 48 of treatment, the TDF group had a significantly higher HBeAg seroconversion rate than the ETV group (14.5% vs 3.9%, P = 0.048); at week 96 of treatment, there was no significant difference in HBeAg seroconversion rate between the two groups (15.8% vs 7.9%, P = 0.132). The Kaplan-Meier survival analysis showed that there were no significant differences between the two groups in cumulative ALT normalization rate, cumulative HBV DNA undetectable rate, and cumulative seroconversion rate. Only one patient in the ETV group experienced virologic breakthrough from weeks 60 to 72 of treatment, and there were no serious adverse reactions. Conclusion: TDF and ETV had similar clinical effects, HBeAg seroconversion rate, and safety in previously untreated HBeAg-positive CHB patients with a high viral load.目的： 比较恩替卡韦（ETV）和替诺福韦酯（TDF）初始治疗高病毒载量HBeAg阳性慢性乙型肝炎(CHB)患者的疗效及安全性。 方法： 回顾性分析152例初始接受ETV和TDF治疗的高病毒载量（HBV DNA定量≥10(6) IU/ml）且HBeAg阳性CHB患者资料，每组患者分别为76例。治疗基线时检测血清丙氨酸氨基转氨酶（ALT）、HBV DNA、HBeAg、抗-HBe、血清肌酐及肌酸激酶水平，并在治疗第4、12、24、36、48、72、84、96周进行随访评估。采用Kaplan-Meimer生存曲线分析累积的完全性病毒学应答、HBeAg血清学转换以及ALT复常率。Cox比例风险回归模型分析病毒学应答的影响因素。P < 0.05为差异有统计学意义。 结果： ETV组患者在4、12、24、48、72、96周的ALT复常率分别为18.1%、55.6%、83.3%、90.3%、93.1%和97.2%，与TDF组患者的ALT复常率16.0%、53.6%、75.4%、94.2%、100%和100%比较，差异均无统计学意义（P值均> 0.05）。ETV组在治疗48、96周的病毒学应答率分别为89.5%、97.3%，与TDF组的93.4%、98.7%比较，差异均无统计学意义（P值均> 0.05）。多因素回归分析各基线参数均不能作为病毒学应答的预测因素。TDF组患者治疗48周比ETV组有更高的HBeAg血清学转换（14.5%对比3.9%），差异有统计学意义（P = 0.048）；96周时两组HBeAg血清学转换率差异无统计学意义（15.8%对比7.9%，P = 0.132）。Kaplan-Meier生存分析显示两组累积ALT复常率、累积HBV DNA不可检测率和累积HBeAg血清学转换率差异均无统计学意义。仅有1例ETV治疗的患者在72周期间发生病毒学突破，均无严重不良事件。 结论： TDF和ETV初始治疗高病毒载量HBeAg阳性慢性乙型肝炎患者抑制HBV病毒的疗效、HBeAg血清学转换率和安全性无差异。.