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日本慢性乙型肝炎病毒感染者核苷(酸)类似物治疗药物由恩替卡韦转换为富马酸替诺福韦艾拉酚胺的意义。

Significance of switching of the nucleos(t)ide analog used to treat Japanese patients with chronic hepatitis B virus infection from entecavir to tenofovir alafenamide fumarate.

机构信息

Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan.

出版信息

J Med Virol. 2020 Mar;92(3):329-338. doi: 10.1002/jmv.25644. Epub 2019 Dec 9.

Abstract

The significance of switching of the nucleos(t)ide analog used to treat patients with hepatitis B virus (HBV) from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) is uncertain. The subjects of this study were 159 patients with HBV who received treatment with ETV followed by TAF. Among these patients, serial changes in the HBV marker levels were monitored in 92 patients in whom the serum HBsAg levels were ≥100 IU/mL during the 48-week period immediately before and after the switching. A questionnaire survey for medication compliance was performed in 127 patients. The serum HBsAg levels (log IU/mL) decreased by 0.041 during the ETV treatment period and by 0.068 during the TAF administration period. The degree of reduction was higher during the TAF administration period than during the ETV administration period in patients without cirrhosis (P = .030), patients with genotype B HBV (P = .014), and patients with undetectable serum HBcrAg (P = .038). Multivariate analysis revealed the HBV genotype (B vs C; odds ratio, 3.400; P = .025) and serum aspartate aminotransferase level (every 1+; 1.111; P = .015) at the time of switching as factors influencing the treatment efficacy. Thirty-six patients (28%) responded that the number of days that they forgot to take the drug decreased after the drug switching, and 77 patients (61%) reported feeling satisfied with the drug switching. Switching of the nucleos(t)ide analog used from ETV to TAF may be useful in the treatment of patients with HBV infection, as it is associated with both a decrease in the serum HBsAg level and improvement of the medication compliance.

摘要

核苷(酸)类似物药物转换治疗乙型肝炎病毒(HBV)患者的意义尚不确定,本研究的对象为 159 例接受恩替卡韦(ETV)治疗后序贯应用替诺福韦艾拉酚胺富马酸酯(TAF)治疗的 HBV 患者,其中 92 例患者在转换前后的 48 周内血清 HBsAg 水平≥100IU/mL,监测了 HBV 标志物水平的连续变化。对 127 例患者进行了药物依从性问卷调查。在 ETV 治疗期间,血清 HBsAg 水平(log IU/mL)下降了 0.041,在 TAF 治疗期间下降了 0.068。在无肝硬化患者(P=.030)、HBV 基因型 B 患者(P=.014)和血清 HBcrAg 不可检测患者(P=.038)中,TAF 治疗期间的下降程度高于 ETV 治疗期间。多因素分析显示,HBV 基因型(B 与 C;优势比,3.400;P=.025)和转换时血清天冬氨酸氨基转移酶水平(每增加 1+;1.111;P=.015)是影响治疗效果的因素。36 例(28%)患者表示药物转换后忘记服药的天数减少,77 例(61%)患者对药物转换表示满意。核苷(酸)类似物药物从 ETV 转换为 TAF 可能对 HBV 感染患者的治疗有益,因为它不仅可以降低血清 HBsAg 水平,还可以改善药物依从性。

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