改用通用恩替卡韦1 mg治疗抗乙型病毒性慢性乙型肝炎后维持

StephenW

Maintaining Antiviral Efficacy after Switching to Generic Entecavir 1 mg for Antiviral-resistant Chronic Hepatitis B
Young Eun Ahn  1 , Sang Jun Suh  1 , Tae Hyung Kim  1 , Young Kul Jung  1 , Hyung Joon Yim  1
Affiliations
Affiliation

    1
    Department of Internal Medicine, Korea Universty College of Medicine, Seoul, Korea.

    PMID: 33372170 DOI: 10.4166/kjg.2020.0144

Abstract

Backgrounds/aims: Clinical equivalence of generic antiviral agents for chronic hepatitis B (CHB) has not been demonstrated, particularly in cases with previous antiviral resistance. Entecavir 1 mg is prescribed frequently as a mono- or combination therapy in antiviral-resistant CHB patients. This study evaluated the efficacy and safety of switching to generic entecavir 1 mg (Baracle®) in CHB patients taking brand-name entecavir 1 mg (Baraclude®) alone or in combination with other nucleotide analogs after the development of antiviral resistance.

Methods: This study was a single-arm prospective study. The primary endpoint was undetectable HBV DNA (<20 IU/mL) at 12 months after switching treatment. The biochemical and serologic responses, virologic breakthrough, and antiviral resistance rates were also evaluated.

Results: Forty CHB patients with undetectable HBV DNA through the brand-name entecavir 1 mg treatment as a mono- or combination therapy after developing antiviral resistance to nucleos(t)ide analogs were enrolled in this study. No significant difference in the HBV DNA non-detection rate was observed between the baseline and 12 months after switching therapy (p=0.324). Furthermore, non-inferiority of the generic entecavir 1 mg to the brand-name entecavir 1 mg with 10% margin in maintaining undetectable HBV DNA was demonstrated (95% CI -2.80 to 8.20%). Similarly, no difference in the biochemical response rate was observed after switching therapy. Serum hepatitis B e antigen loss was observed in 12.5%. No virologic breakthrough was reported.

Conclusions: Generic entecavir 1 mg is a reasonable alternative to the brand-name entecavir 1 mg in antiviral-resistant CHB patients with viral suppression.

Keywords: Entecavir; Hepatitis B; Therapeutics; chronic.

StephenW

改用通用恩替卡韦1 mg治疗抗乙型病毒性慢性乙型肝炎后维持抗病毒效力
Young Eun Ahn 1，Sang Jun Suh 1，Tae Hyung Kim 1，Young Kul Jung 1，Hyung Joon Yim 1
隶属关系
联系

    1个
    韩国首尔大学医学院内科系。

    PMID：33372170 DOI：10.4166 / kjg.2020.0144

抽象

背景/目的：慢性乙型肝炎（CHB）的通用抗病毒药的临床等效性尚未得到证实，特别是在先前具有抗病毒耐药性的情况下。恩替卡韦1毫克经常作为抗病毒耐药CHB患者的单药或联合疗法。这项研究评估了在抗病毒耐药性产生后，单独或与其他核苷酸类似物联合使用名牌恩替卡韦1 mg（Baraclude®）的CHB患者改用通用恩替卡韦1 mg（Baracle®）的有效性和安全性。

方法：本研究为单臂前瞻性研究。主要终点是切换治疗后12个月未检测到HBV DNA（<20 IU / mL）。还评估了生化和血清学反应，病毒学突破和抗病毒耐药率。

结果：本研究招募了40名CHB患者，该患者在对核苷（核苷酸）类似物产生抗病毒耐药性后，通过商品名entecavir 1 mg作为单一或联合治疗，无法检测到HBV DNA。在基线和转换治疗后12个月之间，未观察到HBV DNA未检出率的显着差异（p = 0.324）。此外，还证实了通用恩替卡韦1 mg与商标名称恩替卡韦1 mg在维持不可检测的HBV DNA方面具有10％的利润率（95％CI -2.80至8.20％）。同样，在切换治疗后，未观察到生化反应率的差异。血清乙型肝炎e抗原丢失率为12.5％。没有病毒学突破的报道。

结论：对于抗病毒耐药的CHB病毒抑制患者，通用恩替卡韦1 mg是合理的替代名牌恩替卡韦1 mg的方法。

关键字：恩替卡韦；乙型肝炎；疗法;慢性的。