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在未经治疗的HBV代偿性肝硬化中,病毒抑制与恩替卡韦的每 [复制链接]

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才高八斗

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发表于 2021-1-7 12:58 |只看该作者 |倒序浏览 |打印
Viral suppression is comparable with 0.5 mg and 1.0 mg daily doses of entecavir in treatment-naive HBV decompensated cirrhosis
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    PMID: 33404519 DOI: 10.3851/IMP3375

Abstract

Background: For patients with hepatitis B virus (HBV) infection who have decompensated cirrhosis (DC), a higher dose (1.0 mg/day) of entecavir is recommended than that used for those with compensated disease (0.5 mg/day), though with very little supporting data. We therefore compared the viral suppression achieved with 0.5 mg/day and 1.0 mg/day of entecavir in patients with HBV-related DC (NCT03345498).

Methods: Treatment-naïve patients with HBV-related DC and serum HBV DNA titer exceeding 100,000 IU/mL received either dose of entecavir for 24 weeks. HBV DNA concentration was measured in blood specimens collected at baseline, and after 2, 4, 8, 12 and 24 weeks of entecavir treatment.

Results: Participants in the 0.5 mg/day (n=13) and 1.0 mg/day (n=16) groups had similar baseline HBeAg positivity rates (12/13 and 12/16; p=0.34) and median (range) log10 serum HBV DNA levels (6.81 [5.01-8.12] and 7.45 [5.24-8.65]; p=0.17). The two doses led to similar reductions in serum HBV DNA levels after 2, 4, 8, 12 and 24 weeks of entecavir administration. At 24 weeks, 3 of the 13 patients receiving 0.5 mg/day and one of the 16 patients receiving 1.0 mg/day of entecavir had undetectable serum HBV DNA. Serum albumin level showed significant and similar improvement at the end of 24 weeks in the two groups.

Conclusions: Treatment-naïve patients with HBV-related DC can be treated with entecavir in a 0.5 mg/day dose instead of the higher 1.0 mg/day dose, without compromising the degree of virological suppression.
Associated data

    ClinicalTrials.gov/NCT03345498

Rank: 8Rank: 8

现金
62111 元 
精华
26 
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30441 
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2009-10-5 
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2022-12-28 

才高八斗

2
发表于 2021-1-7 12:59 |只看该作者
在未经治疗的HBV代偿性肝硬化中,病毒抑制与恩替卡韦的每日剂量0.5 mg和1.0 mg恩替卡韦相当
没有列出作者

    PMID:33404519 DOI:10.3851 / IMP3375

抽象

背景:对于患有代偿性肝硬化(DC)的乙型肝炎病毒(HBV)感染患者,推荐恩替卡韦的剂量(1.0 mg /天)要高于那些代偿疾病的患者(0.5 mg /天),尽管很少的支持数据。因此,我们比较了在HBV相关DC(NCT03345498)患者中使用0.5 mg /天和1.0 mg /天的恩替卡韦可获得的病毒抑制作用。

方法:未接受过治疗的,HBV相关DC且血清HBV DNA滴度超过100,000 IU / mL的患者接受任一剂量的恩替卡韦治疗24周。在恩替卡韦治疗的基线,以及第2、4、8、12和24周后收集的血液样本中测量HBV DNA浓度。

结果:0.5 mg /天(n = 13)和1.0 mg /天(n = 16)组的参与者具有相似的基线HBeAg阳性率(12/13和12/16; p = 0.34)和中位数(范围)log10血清HBV DNA水平(6.81 [5.01-8.12]和7.45 [5.24-8.65]; p = 0.17)。在服用恩替卡韦2、4、8、12和24周后,两次剂量导致血清HBV DNA水平出现相似的降低。在第24周时,接受恩替卡韦治疗的13名患者中有3名接受恩替卡韦治疗,其中16名患者中有1名患者的血清HBV DNA检测不到。两组的24周末血清白蛋白水平显示出显着且相似的改善。

结论:可以将恩替卡韦以0.5 mg /天的剂量代替高剂量的1.0 mg /天的剂量使用初治HBV相关DC的患者,而不会损害病毒学抑制的程度。
关联数据

    ClinicalTrials.gov/NCT03345498
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