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

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))、HBe Ag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。

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.