初治慢性乙型肝炎患者从品牌转为仿制药恩替卡韦后的抗病

StephenW

初治慢性乙型肝炎患者从品牌转为仿制药恩替卡韦后的抗病毒疗效分析
许博克 1 2 , 苏培元 1 , 吴嘉琳 3 4 5
隶属关系
隶属关系

    1
    台湾彰化市彰化基督教医院内科消化内科。
    2
    台湾台中中山医科大学医学研究所。
    3
    台湾台中中山医科大学医学院。 [email protected]。
    4
    台湾彰化市彰化基督教医院肾内科。 [email protected]。
    5
    台湾台中国立中兴大学医学院。 [email protected]。

    PMID：35538​​425 DOI：10.1186/s12876-022-02317-7

抽象的

背景/目的：恩替卡韦 (ETV) 可以抑制慢性乙型肝炎 (CHB) 病毒复制，作为治疗药物的标准。对于慢性乙型肝炎的治疗，负担得起的仿制药可能在发展中国家和不发达国家得到更广泛的应用。然而，关于从恩替卡韦品牌药物 (ETV-Brand) 转换为恩替卡韦仿制药 (ETV-Generic) 每天一次 0.5 mg 的临床疗效的真实数据很少。该研究的目的是评估 ETV-Generic 与 ETV-Brand 在 CHB 患者中的抗病毒活性和安全性。

方法：在这项单中心、回顾性研究中，175 名初治 CHB 患者被分配每天接受 0.5 mg ETV-Brand 至少 2 年，然后切换到 ETV-Generic 6 个月进行分析。主要疗效终点是持续病毒学应答，与基线和转换后 6 个月的持续病毒学应答相比，血清乙型肝炎脱氧核糖核酸 (HBV DNA) 检测不到的比率。次要疗效终点是比较转换前后的丙氨酸氨基转移酶 (ALT) 水平和 ALT 正常化。报告了关于改变估计的肾小球滤过率的肾脏安全考虑。

结果：从基线到 6 个月，与使用 ETV-Generic 6 个月的 ETV-Brand 期相比，检测不到 HBV DNA 和 ALT 水平的比率保持稳定。 ETV-Brand 中检测不到 HBV DNA 的比率为 81.1%，而 ETV-Generic 中为 88.0%（p = 0.05 CI 0.1-13.5%）。 ETV-Brand 的 ALT 水平为 27.2 IU/L (CI 24.8-29.6 IU/L)，而 ETV-Generic 的 ALT 水平为 26.2 IU/L (CI 24.0-28.4 IU/L) (p = 0.55)。 ETV 品牌和 ETV 通用治疗之间的两个终点没有显着差异。肾功能与 ETV-Brand（80.8，四分位距 [IQR]：66.6-95.3 mL/min/1.73 m2）与 ETV-Generic 治疗期（80.3，IQR：65.6-93.5 mL/min/1.73 m2）没有显着差异.

结论：在初治慢性乙型肝炎患者中，从 ETV 品牌转换为 ETV 仿制药的疗效和安全性没有差异。总结 ETV-Generic 得出令人兴奋的病毒学反应和罕见的不良事件。

关键词：慢性乙型肝炎；恩替卡韦；仿制药。

© 2022。作者。

StephenW

Analysis of antiviral efficacy after switching from brand to generic entecavir in patients with treatment-naïve chronic hepatitis B
Po-Ke Hsu 1 2 , Pei-Yuan Su 1 , Chia-Lin Wu 3 4 5
Affiliations
Affiliations

    1
    Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
    2
    Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
    3
    School of Medicine, Chung Shan Medical University, Taichung, Taiwan. [email protected].
    4
    Division of Nephrology, Changhua Christian Hospital, Changhua, Taiwan. [email protected].
    5
    School of Medicine, National Chung Hsing University, Taichung, Taiwan. [email protected].

    PMID: 35538425 DOI: 10.1186/s12876-022-02317-7

Abstract

Background/aims: Entecavir (ETV) can suppress chronic hepatitis B (CHB) virus replication as a standard of treatment drugs. For the treatment of CHB, affordable generic drugs may be more widely used in developing and undeveloped countries. However, there is little real-world data regarding the clinical efficacy of switching from entecavir-brand-name drugs (ETV-Brand) to entecavir generic drugs (ETV-Generic) with 0.5 mg once daily. The aim of the study was to evaluate the antiviral activity and safety of ETV-Generic in comparison to ETV-Brand in CHB-patients.

Methods: In this single-center, retrospective, 175 treatment-naïve-CHB-patients were assigned to receive 0.5 mg of ETV-Brand per day for a least 2 years and then switched to ETV-Generic for 6 months for analysis. The primary efficacy endpoint was a sustained virological response in comparison of the rate of undetectable serum Hepatitis B deoxyribonucleic acid (HBV DNA) as the sustained virologic response at baseline and 6 months after switching. Secondary efficacy endpoints were the comparison of the alanine aminotransferase (ALT) levels between before and after switching and ALT normalization. Renal safety consideration was reported on changing the estimated glomerular filtration rate.

Results: From baseline to 6 months, the rate of undetectable HBV DNA and ALT levels remained stable as compared to ETV-Brand period with ETV-Generic for 6 months. The rate of undetectable HBV DNA were 81.1% in ETV-Brand versus 88.0%in ETV-Generic (p = 0.05 CI 0.1-13.5%). ALT levels were 27.2 IU/L (CI 24.8-29.6 IU/L) in ETV-Brand versus 26.2 IU/L (CI 24.0-28.4 IU/L) in ETV -Generic (p = 0.55). Both endpoints were not significantly different between ETV-Brand and ETV-Generic treatments. Kidney function did not significantly differ from ETV-Brand (80.8, interquartile range [IQR]: 66.6-95.3 mL/min/ 1.73 m2) to ETV-Generic treatment period (80.3, IQR: 65.6-93.5 mL/min/1.73 m2).

Conclusion: In treatment-naïve CHB-patients, the efficacy and safety profiles of switching from ETV-Brand to ETV-Generic showed no difference. Concluding the ETV-Generic comes to exciting virologic responses and rare adverse events.

Keywords: Chronic hepatitis B; Entecavir; Generic drugs.

© 2022. The Author(s).

StephenW

https://bmcgastroenterol.biomedc ... /s12876-022-02317-7