转换为替诺福韦地索普西富马酸盐与继续治疗慢性乙型肝炎

StephenW

J Med Virol. 2019 Feb 28. doi: 10.1002/jmv.25442. [Epub ahead of print]
Switching to tenofovir disoproxil fumarate versus continuing treatment in chronic hepatitis B patients who maintain long-term virological response to entecavir therapy: a randomized trial.
Iida-Ueno A1, Enomoto M1, Kozuka R1, Tamori A1, Kawada N1.
Author information

1
    Department of Hepatology, Graduate School of Medicine, Osaka City University Medical School, Osaka, Japan.

Abstract

No controlled trial in patients with chronic hepatitis B virus (HBV) infection on long-term entecavir (ETV) treatment, comparing switching to tenofovir disoproxil fumarate (TDF) with continuing the therapy, has been reported. Twenty-seven nucleos(t)ide-naïve patients with chronic HBV who underwent ETV therapy for ≥5 years and maintained virological response were included, and randomized into two groups: one group continued ETV, and the other switched to TDF, in a 1:2 ratio. The primary endpoint was change from baseline in serum hepatitis B surface antigen (HBsAg) level at week 48. The baseline characteristics were not different between 19 patients in the TDF group and 8 patients in the ETV group. Mean decreases in HBsAg level at week 48 were 0.023 and 0.042 log10 IU/mL in the TDF and ETV groups, respectively (P = 0.94). The mean drops in hepatitis B core-related antigens (HBcrAg) were also not different between the TDF and ETV groups at week 48 (P = 0.80). HBV DNA was sustainedly <2.1 log10 copies/mL in all patients throughout the study period. In contrast, the mean aminotransferase levels were significantly higher in the TDF group than in the ETV group at weeks 12, 24 and 36, although being within the reference range. Estimated glomerular filtration rate was lower in the TDF group than in the ETV group at weeks 24 (P = 0.016) and 48 (P = 0.003). In conclusion, we could not find the effect on reducing HBsAg level by switching to TDF in chronic hepatitis B patients with maintained virological response to ETV for ≥5 years. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.
KEYWORDS:

ETV; HBV; RCT; TDF; nucleos(t)ide analogs

PMID:
    30815880
DOI:
    10.1002/jmv.25442

StephenW

J Med Virol。 2019年2月28日doi：10.1002 / jmv.25442。 [印刷前的电子版]
转换为替诺福韦地索普西富马酸盐与继续治疗慢性乙型肝炎患者，对恩替卡韦治疗保持长期病毒学应答：一项随机试验。
Iida-Ueno A1，En本M1，Kozuka R1，Tamori A1，Kawada N1。
作者信息

1
    日本大阪大阪市立大学医学研究院肝病学系。

抽象

据报道，对长期恩替卡韦（ETV）治疗的慢性乙型肝炎病毒（HBV）感染患者进行无对照试验，比较转换为替诺福韦地索普西富马酸盐（TDF）与继续治疗。纳入27例接受ETV治疗≥5年并保持病毒学应答的慢性HBV患者，并随机分为两组：一组继续ETV，另一组转为TDF，一组：2比率。主要终点是第48周血清乙型肝炎表面抗原（HBsAg）水平从基线的变化.TDF组的19名患者和ETV组的8名患者的基线特征没有差异。第48周时HBsAg水平的平均降低分别为0.023和0.042 log10 IU / mL（P = 0.94）。在第48周，TDF和ETV组之间乙型肝炎核心相关抗原（HBcrAg）的平均下降也没有差异（P = 0.80）。在整个研究期间，所有患者的HBV DNA持续<2.1 log10拷贝/ mL。相比之下，TDF组的平均氨基转移酶水平在第12周，第24周和第36周时显着高于ETV组，尽管在参考范围内。在第24周（P = 0.016）和48（P = 0.003），TDF组的估计肾小球滤过率低于ETV组。总之，我们未能发现在对ETV维持病毒学反应≥5年的慢性乙型肝炎患者中转为TDF可降低HBsAg水平的效果。本文受版权保护。版权所有。

本文受版权保护。版权所有。
关键词：

ETV; HBV; RCT; TDF;核苷（酸）类似物

结论：
    30815880
DOI：
    10.1002 / jmv.25442