Baracle®与Baraclude®：疗效与安全性的比较

StephenW

Drug Des Devel Ther. 2017 Oct 31;11:3145-3152. doi: 10.2147/DDDT.S149199. eCollection 2017.
Baracle® vs Baraclude® for 48 weeks in patients with treatment-naïve chronic hepatitis B: a comparison of efficacy and safety.
Kim DY1, Kim JH2, Tak WY3, Yeon JE4, Lee JH5, Yoon JH6, Lee YJ7, Lee BS8, Han BH9, Lee HC10.
Baracle®与Baraclude®治疗初治慢性乙型肝炎共48周：疗效与安全性的比较
Author information

1
    Department of Internal Medicine, Yonsei University College of Medicine, Seoul.
2
    Department of Gastroenterology, Gachon University Gil Medical Center, Incheon.
3
    Department of Internal Medicine, Kyungpook National University Hospital, Daegu.
4
    Department of Internal Medicine, Korea University Guro Hospital, Seoul.
5
    Department of Gastroenterology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
6
    Department of Internal Medicine, Seoul National University Hospital, Seoul.
7
    Department of Gastroenterology, Inje University Busan Paik Hospital, Busan.
8
    Department of Gastroenterology, Chungnam National University Hospital, Daejeon.
9
    Department of Gastroenterology, Kosin University Gospel Hospital, Busan.
10
    Department of Internal Medicine, Asan Medical Center, Ulsan University, Seoul, Republic of Korea.

Abstract
Background and objective:

Entecavir (ETV) is a standard of care for chronic hepatitis B (CHB). In a bioequivalence study, ETV from Dong-A ST (Baracle®) was found to have a pharmacokinetic profile equivalent to ETV from Bristol-Myers Squibb (BMS) (Baraclude®). The present study was conducted to evaluate the antiviral activity and safety of ETV from Dong-A ST in comparison to ETV from BMS in patients with CHB.
Methods:

In this multicenter, double-blind, active-controlled, stratified-randomized, parallel group, comparative trial, 118 treatment-naïve patients with CHB were randomly assigned to receive either 0.5 mg of ETV from Dong-A ST or ETV from BMS once daily for 48 weeks. The primary efficacy endpoint was virologic improvement (a mean reduction from baseline in serum HBV DNA levels) at 24 weeks. Secondary efficacy endpoints included a mean reduction in serum HBV DNA levels at 48 weeks, proportion of patients with undetectable levels of serum HBV DNA, rates of hepatitis B e antigen (HBeAg) loss and seroconversion, rates of HBsAg loss and seroconversion, and rates of normalization of alanine aminotransferase (ALT) levels.
Results:

From baseline to week 24, HBV DNA levels (log10) decreased by 4.81 and 4.63 with ETV from Dong-A ST and with ETV from BMS, respectively. The upper limit of two-sided 95% confidence intervals (CI) (equivalent to one-sided 97.5% CIs) for the difference between the treatment groups was 0.208, which was below the noninferiority margin of 1, thus supporting the noninferiority of ETV from Dong-A ST in comparison to ETV from BMS. No statistically significant differences were noted between the treatment groups in all secondary and tertiary efficacy endpoints. Safety profiles were also similar between the two groups.
Conclusion:

In patients with previously untreated HBeAg-positive or negative HBV infection, the efficacy of ETV from Dong-A ST was noninferior to that of ETV from BMS, and there were no significant differences in efficacy or safety between two groups.
KEYWORDS:

ETV from Dong-A ST (Baracle®); chronic hepatitis B; generic

PMID:
    29184389
PMCID:
    PMC5673034
DOI:
    10.2147/DDDT.S149199

StephenW

Drug Des Devel Ther。 2017年10月31日; 11：3145-3152。 doi：10.2147 / DDDT.S149199。 eCollection 2017。
Baracle®与Baraclude®治疗初治慢性乙型肝炎患者共48周：疗效与安全性的比较。
Kim DY1，Kim JH2，Tak WY3，Yeon JE4，Lee JH5，Yoon JH6，Lee YJ7，Lee BS8，Han BH9，Lee HC10。
Baracle®与Baraclude®治疗初治慢性乙型肝炎患者共48周：疗效与安全性的比较
作者信息

1
    首尔延世大学医学院内科。
2
    Gachon大学消化内科Gil医学中心仁川。
3
    大邱庆北大学附属医院内科
4
    首尔高丽大学九老医院内科。
五
    首尔成均馆大学医学院三星医疗中心消化科。
6
    首尔首尔国立大学医院内科。
7
    釜山仁济大学釜山白医院消化内科
8
    大田忠南国立大学医院消化内科
9
    釜山Kosin大学福音医院消化科。
10
    韩国首尔蔚山大学牙山医学中心内科。

抽象
背景和目标：

恩替卡韦（ETV）是慢性乙型肝炎（CHB）的标准护理。在生物等效性研究中，发现东亚ST（Baracle®）的ETV的药代动力学特征与Bristol-Myers Squibb（BMS）（Baraclude®）的ETV相当。本研究旨在评估东亚ST患者ETV的抗病毒活性和安全性，以及CHB患者BMS ETV的安全性。
方法：

在这项多中心双盲，主动控制，分层随机，平行组比较试验中，118名未接受过CHB治疗的初治患者被随机分配接受东亚ST的ETV 0.5mg或BMS的ETV持续48周。主要疗效终点为24周时的病毒学改善（血清HBV DNA水平从基线平均降低）。次要疗效终点包括48周时血清HBV DNA水平的平均降低，血清HBV DNA水平检测不到的患者比例，乙型肝炎e抗原（HBeAg）丢失率和血清转化率，HBsAg消失率和血清转化率，以及丙氨酸转氨酶（ALT）水平的正常化。
结果：

从基线至第24周，来自东亚ST的ETV和来自BMS的ETV的HBV DNA水平（log10）分别下降4.81和4.63。治疗组之间差异的双侧95％置信区间（CI）（相当于单侧97.5％CIs）的上限为0.208，低于非劣性边界1，因此支持ETV的非劣效性东亚ST与BMS的ETV相比。所有二级和三级疗效终点在治疗组之间没有统计学显着性差异。两组的安全性也相似。
结论：

对于既往未接受过HBeAg阳性或HBV感染阴性的患者，东亚ST组的ETV疗效不劣于BMS组的ETV疗效，两组疗效和安全性无显着差异。
关键词：

来自东亚ST（Baracle®）的ETV;慢性乙型肝炎;通用

结论：
    29184389
PMCID：
    PMC5673034
DOI：
    10.2147 / DDDT.S149199