Viral suppression is comparable with 0.5 mg and 1.0 mg daily doses of entecavir in treatment-naive HBV-related decompensated cirrhosis.

IF 1.3 4区医学 Q4 INFECTIOUS DISEASES

Antiviral Therapy Pub Date : 2020-01-01 DOI:10.3851/IMP3375

Amit Goel, Sumit Rungta, Prashant Verma, Abhai Verma, Ajay Narayan Verma, Praveer Rai, Rakesh Aggarwal

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引用次数: 0

Abstract

Background: For patients with 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-naive patients with HBV-related DC and serum HBV DNA titre 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 hepatitis B e antigen (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 1 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-naive 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. ClincialTrials.gov number NCT03345498.

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在初次治疗的hbv相关失代偿性肝硬化中，每日剂量为0.5 mg和1.0 mg的恩替卡韦对病毒的抑制效果相当。

背景:对于患有失代偿性肝硬化(DC)的HBV感染患者，建议使用更高剂量(1.0 mg/天)的恩替卡韦，而不是用于代偿性疾病(0.5 mg/天)的患者，尽管很少有支持数据。因此，我们比较了0.5 mg/天和1.0 mg/天恩替卡韦对hbv相关DC患者(NCT03345498)的病毒抑制效果。方法:HBV相关DC和血清HBV DNA滴度超过100,000 IU/ml的未接受治疗的患者接受两种剂量的恩替卡韦治疗24周。在基线和恩替卡韦治疗2、4、8、12和24周后采集的血液标本中测量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乙型肝炎e抗原(HBeAg)阳性率(12/13和12/16;P=0.34)和中位(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)。在恩替卡韦给药2、4、8、12和24周后，两种剂量的血清HBV DNA水平下降相似。在24周时，接受0.5 mg/天恩替卡韦治疗的13例患者中有3例和接受1.0 mg/天恩替卡韦治疗的16例患者中有1例血清HBV DNA检测不到。24周后，两组患者血清白蛋白水平均有明显改善。结论:未接受治疗的hbv相关DC患者可以用0.5 mg/天的恩替卡韦治疗，而不是更高的1.0 mg/天的剂量，而不会影响病毒学抑制的程度。ClincialTrials.gov号码NCT03345498。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Antiviral Therapy 医学-病毒学

CiteScore

2.60

自引率

8.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.