ALT升高、低病毒载量慢性乙型肝炎患者不确定期采用不同抗病毒治疗方案的疗效及安全性

The Efficacy and Safety of Different Antiviral Treatment Regimens in Patients with ALT Elevation and Low Viral Load in the Indeterminate Phase of Chronic Hepatitis B

目的 观察初治的低病毒载量不确定期慢乙肝患者采用一线核苷(酸)类药物抗病毒治疗后的临床疗效及安全性。方法 纳入2019年1月至2022年4月期间在昆明市第三人民医院门诊就诊的96例初治低病毒载量不确定期慢性乙肝患者,根据使用药物不同将患者分为恩替卡韦组(ETV组)、富马酸替诺福韦酯组(TDF组)和富马酸丙酚替诺福韦组(TAF组)。在持续用药的第12周、24周、48周观察3组的临床疗效及安全性差异。结果 经抗病毒治疗48周后,总共96.88%(93/96)患者HBV DNA获得完全病毒学应答(complete virologic response,CVR,定义为HBV DNA <100 IU/mL),3组的CVR率为:ETV组96.97%(32/33),TDF组96.97%(32/33),TAF组96.67%(29/30),组间差异无统计学意义(P=0.997)。治疗48周时HBsAg水平较基线均有显著下降,但3组差异无统计学意义(P=0.348)。TAF组较ETV组(P=0.013)、TDF组(P=0.047)显著提升eGFR水平,AFP水平较ETV组(P=0.008)和TDF组(P=0.007)显著下降。48周ALT复常率:TAF组(70%)和TDF组(45.45%),ETV组(60.61%)差异无统计学意义(P=0.135)。治疗期间无严重不良事件发生。结论 治疗48周后3组CVR率均达96%以上,AFP水平下降及eGFR水平改善TAF组优于ETV组及TDF组,对ALT升高、低病毒载量慢乙肝不确定期患者行抗病毒治疗可使患者获益。

Objective To observe the clinical efficacy and safety of first-line nucleos(t)ide analogues antiviral therapy in newly diagnosed chronic hepatitis B patients with low viral load and uncertain stage.Methods A total of 96 diagnosed treatment-naive chronic hepatitis B patients with low viral load in indeterminate stage who attended Kunming Third People’s Hospital from January 2019 to April 2022 were included and divided into the ETV group,TDF group and TAF group according to the drugs used.The differences in clinical efficacy and safety of the three groups were observed at the 12thW,24thW and 48thW of continuous dosing.Results After 48 weeks of the antiviral treatment,a total of 96.88%(93/96) patients achieved complete virologic response(CVR,defined as HBV DNA < 100 IU/mL) to HBV DNA,with CVR rates in the three groups:96.97%(32/33) in the ETV group,96.97%(32/33) in the TDF group 96.97%(32/33),and 96.67%(29/30) in the TAF group,with no statistically significant difference among the three groups(P = 0.997).HBsAg levels decreased significantly at 48 weeks of treatment compared to the baseline in all three groups,but there was no statistically significant difference among the three groups(P = 0.348).eGFR levels were significantly elevated in the TAF group compared to those in the ETV group(P = 0.013) and the TDF group(P = 0.047),and AFP levels decreased significantly compared to those in the ETV group(P = 0.008) and the TDF group(P = 0.007).There was no significant difference of ALT recurrence rate for 48 weeks among TAF group(70%),TDF group(45.45%) and ETV group(60.61%)(P =0.135).No serious adverse events occurred during the treatment period.Conclusion The CVR rate of all three groups has reached more than 96% after 48 weeks of the treatment,the ALT normalization rate of the TAF group is better than that of the TDF group,and the decrease in AFP level and improvement in eGFR level of the TAF group are better than those of the ETV and TDF groups.The patients with elevated ALT and low viral load in the indeterminate phase of chronic hepatitis B could benefit from antiviral therapy.