富马酸丙酚替诺福韦单药治疗恩替卡韦初治后低病毒血症的慢性乙型肝炎患者优于加用富马酸替诺福韦二吡呋酯策略
Efficacy of tenofovir alafenamide monotherapy compared to tenofovir disoproxil fumarate addition in chronic hepatitis B patients with low-level viremia after entecavir treatment
杨忠祥 1石荔 1钱花 1温青萍 1田静 1巴桑1
作者信息
- 1. 西藏自治区人民医院感染性疾病科西藏大学医学院,西藏自治区拉萨 850000
- 折叠
摘要
目的 观察恩替卡韦(entecavir,ETV)初治后低病毒血症(low-level viremia,LLV)的慢性乙型肝炎(chronic hepatitis B,CHB)患者转换不同治疗策略后的临床疗效.方法 筛选2020年1月-2023年12月就诊于西藏自治区人民医院的CHB患者,选取经ETV初治48周后低病毒血症患者80例,根据治疗方案不同分为观察组和对照组,每组40例.观察组转换为富马酸丙酚替诺福韦(tenofoviral afenamide,TAF)抗病毒治疗48周,对照组在ETV基础上加用富马酸替诺福韦二吡呋醋(tenofovir disoproxil fumarate,TDF)抗病毒治疗48周.比较两组患者治疗后24、48周时的完全病毒学应答(complete virological response,CVR)率、HBeAg阴转率、估算肾小球滤过率(estimated glomerular filtration rate,eGFR)、肝硬度值测定(liver stiffness measurement,LSM)、肝功能变化及药物不良反应等.结果 对照组和观察组在24周(90.00％比 92.50％,x2=0.215,P=0.847)、48 周(92.50％比 97.50％,x2=0.347,P=0.732)时的CVR率比较差异无统计学意义;对照组和观察组在24周(9.38％比15.15％,x2=0.556,P=0.712)、48周(15.63％比36.36％,x2=3.660,P=0.099)时的HBeAg阴转率差异无统计学意义.观察组在48周时的eGFR、LSM改善程度优于对照组(t=5.642,t=7.853,P＜0.001);两组在24周、48周的丙氨酸氨基转移酶(alanine transaminase,ALT)、天冬氨酸氨基转移酶(aspartate aminotransferase,AST)、总胆红素(total bilirubin,TBIL)差异无统计学意义;治疗期间观察组及对照组均无严重不良反应.结论 单用TAF在改善ETV初治后LLV的CHB患者抗病毒效果、降低LSM值及肾脏安全性方面优于ETV和TDF联用,且不良反应少.
Abstract
Objective To observe the clinical efficacy of different treatment strategies in chronic hepatitis B(CHB)patients with low-level viremia(LLV)after initial entecavir(ETV)therapy.Methods A total of 80 CHB patients who experienced LLV after 48 weeks of initial treatment with ETV at Tibet Autonomous Region People's Hospital from January 2020 to December 2023 were selected.Patients were divided into 40 cases each in the observation group and the control group,according to the different treatment regimens.The observation group was converted to antiviral treatment with tenofovir alofovir(TAF)for 48 weeks,while the control group received a combination of ETV and tenofovir disoprofoxil fumarate(TDF)for 48 weeks.The complete virological response(CVR)rate,HBeAg negative rate,estimated glomerular filtration rate(eGFR),liver stiffness mea-surement(LSM),liver function changes,and adverse drug reactions were compared between the two groups at 24 and 48 weeks post-treatment.Results There were no statistically significant differences in CVR rates be-tween the control group and the observation group at week 24(90.00％vs 92.50％,x2=0.215,P=0.847)and week 48(92.50％vs 97.50％,x2=0.347,P=0.732).The difference in HBeAg-negative rates between control and observation groups at week 24(9.38％vs 15.15％,x2=0.556,P=0.712)and 48(15.63％vs 36.36％,x2=3.660,P=0.099)was statistically significant.The improvement in eGFR and LSM in the obser-vation group was better than that of the control group at week 48(t=5.642,t=7.853,P＜0.001).There were no statistically significant differences in alanine transaminase(ALT),aspartate aminotransferase(AST),and total bilirubin(TBIL)values between the two groups at week 24 and week 48.No serious adverse reactions occurred in either group during the treatment period.Conclusion TAF monotherapy demonstrates superior antiviral efficacy,lowering LSM values,and renal safety compared to the combination of ETV and TDF in CHB patients with LLV following initial ETV treatment,with fewer adverse reactions.
关键词
慢性乙型肝炎/低病毒血症/恩替卡韦/富马酸丙酚替诺福韦/富马酸替诺福韦二吡呋酯Key words
Chronic hepatitis B/Low-level viremia/Entecavir/Tenofovir alafenamide/Tenofovir disoproxil fumarate引用本文复制引用
出版年
2024
NETL
NSTL
万方数据