恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及依从性的多中心队列研究

doi:10.5246/jcps.2021.12.085

中国药学(英文版) ›› 2021, Vol. 30 ›› Issue (12): 986-993.DOI: 10.5246/jcps.2021.12.085

• 【药事管理与临床药学专栏】 • 上一篇下一篇

恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及依从性的多中心队列研究

谢英¹, 战寒秋², 朱晓虹³, 李源⁴, 田如意⁴, 张静¹, 陈姗姗¹, 赵艳玲¹^,^*()

1. 解放军总医院第五医学中心药剂科, 北京 100039
2. 首都医科大学附属北京地坛医院药剂科, 北京 100015
3. 首都医科大学附属北京佑安医院药剂科, 北京 100069
4. 解放军总医院第五医学中心信息科, 北京 100039

收稿日期:2021-07-23 修回日期:2021-08-14 接受日期:2021-09-06 出版日期:2021-12-24 发布日期:2021-12-20
通讯作者: 赵艳玲
作者简介:
+ Tel.: +86-13681208998, E-mail: x490065470@163.com
基金资助:
Beijing Pharmacological Society and Science Foundation of Sichuan Education Department (Grant No. 18ZA0186).

Comparison of the efficacy and adherence of generic and brand-name entecavirs in chronic hepatitis B patients: a multicenter cohort study

Ying Xie¹, Hanqiu Zhan², Xiaohong Zhu³, Yuan Li⁴, Ruyi Tian⁴, Jing Zhang¹, Shanshan Chen¹, Yanling Zhao¹^,^*()

1 Department of Pharmacy, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
2 Department of Pharmacy, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
3 Department of Pharmacy, Beijing YouAn Hospital, Capital Medical University, Beijing 100069, China
4 Department of Medical Information, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China

Received:2021-07-23 Revised:2021-08-14 Accepted:2021-09-06 Online:2021-12-24 Published:2021-12-20
Contact: Yanling Zhao

摘要/Abstract

摘要：

本研究旨在比较润众(恩替卡韦仿制药, 南京天晴)和博路定(恩替卡韦原研药, 百时美施贵宝)治疗慢性乙型肝炎患者的疗效和依从性。研究收集三所传染病医院慢性乙型肝炎患者的48周随访数据, 并使用倾向评分匹配法校正后对两药进行比较。总共纳入4889名患者: 其中原研药组503名, 仿制药组4386名。仿制药组和原研药组在24和48周时的CVR(完全病毒学应答率)、VB(病毒学突破率)没有统计学差异。两组间的HBeAg转阴率、药物占有率(MPR)和生物学应答率也无统计学差异。年龄、性别(HR 0.909 (0.842–0.981))、基线ALT阳性率(HR 0.789 (0.731–0.851))、HBeAg阳性率和基线HBV DNA阳性率(HR 0.306 (0.234–0.399))是CVR的独立风险因素。

关键词: 恩替卡韦, 依从性, 仿制药, 原研药

Abstract:

In the present study, we aimed to compare the efficacy and adherence of Runzhong^? (generic drug, Chiatai Tianqing, Nanjing) and Baraclude^? (branded drug, Bristol-Myers Squibb) in patients with chronic hepatitis B. We collected patient data from three hospitals within 48 weeks and compared the two groups by using the propensity-score matching method. A total of 4889 patients were enrolled in this study; 503 initiated a brand-name drug, and 4386 received a generic drug. There was no significant difference in the rates of CVR (complete virologic response) and VB (virologic breakthrough) between the Runzhong^? group and Baraclude^? group at 24 and 48 weeks. Similar results for HBeAg loss, medication possession ratio (MPR), and biological response were obtained. Age, gender (HR 0.909 (0.842–0.981)), normal baseline ALT rate (HR 0.789 (0.731–0.851)), HBeAg-positive rate, and baseline undetectable HBV DNA rate (HR 0.306 (0.234–0.399)) were independent factors for achieving CVR.

Key words: Entecavir, Adherence, Generic drug, Branded drug

Supporting:

谢英, 战寒秋, 朱晓虹, 李源, 田如意, 张静, 陈姗姗, 赵艳玲. 恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及依从性的多中心队列研究[J]. 中国药学(英文版), 2021, 30(12): 986-993.

Ying Xie, Hanqiu Zhan, Xiaohong Zhu, Yuan Li, Ruyi Tian, Jing Zhang, Shanshan Chen, Yanling Zhao. Comparison of the efficacy and adherence of generic and brand-name entecavirs in chronic hepatitis B patients: a multicenter cohort study[J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(12): 986-993.

图/表 4

Figure 1. Flowchart of patient enrollment.

Table 1. The baseline characteristics of patients in the initial screening.

Table 2. Factors in virologic response between two groups.

Figure 2. (a) Kaplan-Meier curve for the cumulative probabilities of achieving complete virological response for all patients over treatment duration. P value was determined using log-rank test; (b) Kaplan-Meier curve for the cumulative probabilities of virological breakthrough for all patients over treatment duration. P value was determined using log-rank test; (c) Kaplan-Meier curve for the cumulative probabilities of HBeAg clearance over treatment duration. P value was determined using log-rank test.

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恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及依从性的多中心队列研究

Comparison of the efficacy and adherence of generic and brand-name entecavirs in chronic hepatitis B patients: a multicenter cohort study

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