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替诺福韦艾拉酚胺富马酸盐在恩替卡韦治疗期间 HBV DNA 可检测的慢性乙型肝炎患者中的应用。

Switching to Tenofovir Alafenamide Fumarate in Chronic Hepatitis B Patients Who Had Detectable HBV DNA during Treatment with Entecavir.

机构信息

Division of Gastroenterology, Tohoku University Graduate School of Medicine.

Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital.

出版信息

Tohoku J Exp Med. 2022 Nov 12;258(4):277-285. doi: 10.1620/tjem.2022.J084. Epub 2022 Oct 14.

Abstract

Nucleos(t)ide analogues (NAs) suppress hepatitis B virus (HBV) replication, but the risk of hepatocellular carcinoma still remains. The presence of detectable HBV DNA in the serum during NA therapies for chronic hepatitis B patients has been reported to be associated with the risk of hepatocellular carcinoma. In this study, we investigated the antiviral effect of switching from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who had detectable HBV DNA in the serum at least once within a year. Among a total of 77 cases in 7 hospitals that switched NAs from ETV to TAF, 23 patients with detectable HBV DNA in a year before switching were analyzed. When the detection frequencies of HBV DNA in the 1st and 2nd years after switching to TAF were analyzed, they were significantly lower than those in the year before switching (68.8% vs. 34.1% for the 1st year and 21.3% for the 2nd year, P < 0.001 for both). The HBsAg decline tended to be larger after switching than before (-2.5% vs. -3.0% for 1st year and -3.1% for 2nd year), but the difference was not significant. One patient died of a cardiovascular event 11 months after the treatment switch, but no adverse effects due to TAF including renal function were observed. In conclusion, it was suggested that switching from ETV to TAF might be effective to suppress the HBV DNA level further in patients whose HBV DNA is detectable, even if at a very low level.

摘要

核苷酸类似物(NAs)可抑制乙型肝炎病毒(HBV)复制,但仍存在肝细胞癌的风险。在慢性乙型肝炎患者的 NAs 治疗期间,血清中可检测到 HBV DNA 已被报道与肝细胞癌的风险相关。在这项研究中,我们研究了在血清中至少有一次可检测到 HBV DNA 的慢性乙型肝炎患者中,从恩替卡韦(ETV)转换为富马酸替诺福韦艾拉酚胺(TAF)的抗病毒效果。在总共 7 家医院的 77 例患者中,有 23 例患者在转换 NAs 之前的一年内可检测到 HBV DNA。当分析转换为 TAF 后的第 1 年和第 2 年的 HBV DNA 检测频率时,它们明显低于转换前的那一年(第 1 年分别为 68.8%和 34.1%,第 2 年为 21.3%,均<0.001)。与转换前相比,转换后 HBsAg 下降的趋势更大(第 1 年分别为-2.5%和-3.0%,第 2 年为-3.1%),但差异无统计学意义。1 例患者在治疗转换后 11 个月因心血管事件死亡,但未观察到 TAF 引起的任何不良反应,包括肾功能异常。总之,在 HBV DNA 可检测到的患者中,即使水平非常低,从 ETV 转换为 TAF 可能也有助于进一步抑制 HBV DNA 水平。

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