哪位知道权威的恩替6年数据是否已出？

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哪位知道权威的恩替6年数据是否已出？

亭亭如盖矣

帮顶

祝福下

MiddleAgeMan

Not the 6 year continuous use.

But there is one for 96 weeks entecavir mono compared with entecavir+tenoforvir. It is phase III B. It is done by entecavir drug maker: Bristol-Myers Squibb Company
the conclusion is entecavir entecavir+tenoforvir is not better than entecavir mono.

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Phase IIIb Comparison of BARACLUDE® (entecavir) Monotherapy versus BARACLUDE plus Tenofovir Combination Shows No Statistical Difference Between Study Arms
• 96-week study in a population of nucleos(t)ide-naïve patients with chronic hepatitis B (CHB) infection • Data presented at the American Association for the Study of Liver Diseases congress in San Francisco
ShareThis  Email  PDF  Print .San Francisco, CA (PRWEB) November 09, 2011

Bristol-Myers Squibb Company (NYSE: BMY) today announced 96-week results from the BE‐LOW™ study, a Phase IIIb clinical trial comparing BARACLUDE monotherapy (0.5mg once daily) with BARACLUDE (0.5mg once daily) plus tenofovir (300mg once daily) in treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) with compensated liver disease. In this study, no statistically significant difference was observed between the two treatment arms in the primary efficacy endpoint of HBV DNA <50 IU/mL (approximately 300 copies per mL) (1) at 96 weeks: 76.4% in the BARACLUDE monotherapy arm and 83.2% in the BARACLUDE plus tenofovir arm (p=0.0882). Overall, both study arms had similar safety profiles. Serious adverse events (SAEs) in this study were reported in 6.6% (12/182) of patients in the BARACLUDE monotherapy arm and in 7.1% (14/197) of patients in the BARACLUDE plus tenofovir arm. These data were reported at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California (Abstract #223, presented orally during the Presidential Plenary Session on Viral Hepatitis).

“In these 96-week data comparing entecavir monotherapy to combination of entecavir plus tenofovir, we found that combination therapy did not result in statistically significant difference in virologic response compared to entecavir monotherapy. The BE-LOW study data confirmed the results of previous studies showing limited or no benefit of combination therapy compared to monotherapy for treatment-naïve patients with chronic hepatitis B,” said principal investigator Anna Lok, MD, FRCP, director of clinical hepatology and professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor.

Study Results

In this study, 379 nucleos(t)ide-naïve patients with CHB were randomized to receive either BARACLUDE (entecavir) 0.5 mg once daily (n=182) or BARACLUDE 0.5 mg plus tenofovir 300 mg once daily (n=197). Key findings at week 96 are:


A comparable proportion of patients in both treatment arms achieved the primary efficacy endpoint of HBV DNA <50 IU/mL at 96 weeks: 76.4% (139/182) in the BARACLUDE monotherapy arm and 83.2% (164/197) in the BARACLUDE plus tenofovir arm (p=0.0882).
Among HBeAg-positive patients, the proportion achieving HBV DNA <50 IU/mL was 69.8% (88/126) in the BARACLUDE monotherapy arm versus 80.4% (111/138) in the BARACLUDE plus tenofovir arm (p=0.0460). Further analysis suggested that this difference could be accounted for by the subset of patients with a high baseline viral load. Among those HBeAg-positive patients with a baseline viral load <10^8 IU/mL, 83% achieved HBV DNA less than 50 IU/mL in both treatment arms (BARACLUDE monotherapy 39/47; BARACLUDE plus tenofovir 44/53; p=ns). However, for those with a baseline viral load ≥108 IU/mL, 62% (49/79) of the patients in the BARACLUDE monotherapy arm and 78.8% (67/85) of the patients in the BARACLUDE plus tenofovir arm achieved HBV DNA <50 IU/mL.
Among HBeAg-negative patients, the proportion achieving HBV DNA <50 IU/mL was 91.1% (51/56) in the BARACLUDE monotherapy arm versus 89.8% (53/59) in the BARACLUDE plus tenofovir arm.

Secondary efficacy endpoints measured in the study included alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and HBeAg loss. ALT normalization was observed in 81.9% (149/182) of patients in this study in the BARACLUDE (entecavir) monotherapy arm versus 69% (136/197) in the BARACLUDE plus tenofovir arm. HBeAg seroconversion was observed in 32.5% (41/126) of patients in the BARACLUDE (entecavir) monotherapy arm versus 21.7% (30/138) in the BARACLUDE plus tenofovir arm in this study.

Two patients (1.1%) in the BARACLUDE monotherapy arm compared to five patients (2.5%) in the BARACLUDE plus tenofovir arm discontinued treatment prior to week 96. Patients who discontinued therapy prior to week 96 were considered treatment failures.

The overall adverse event profiles were similar across study arms. A total of three deaths occurred among treated patients, all on the BARACLUDE plus tenofovir arm: one due to bile duct tumor; one due to a late-onset exacerbation of hepatitis which was associated with breakthrough viremia while on continued treatment; and one due to cardiac arrest. One patient (0.5%) in the BARACLUDE monotherapy arm and two patients (1.0%) in the BARACLUDE plus tenofovir arm experienced on treatment ALT flares, defined as greater than 2 x baseline ALT and greater than 10 x ULN. No patients (0.0%) in either arm experienced off-treatment ALT flares. Six patients (3.3%) in the BARACLUDE monotherapy arm and four (2.0%) patients in the BARACLUDE plus tenofovir arm experienced serum creatinine increase ≥0.3 mg/dL. A total of five malignancies occurred among patients in the study: four (2.2%) patients in the BARACLUDE monotherapy arm and one (0.5%) patient in the BARACLUDE plus tenofovir arm. In the BARACLUDE monotherapy arm, there were three diagnoses of hepatocellular carcinoma (two on-treatment and one off-treatment) and one case of gastric cancer. In the BARACLUDE plus tenofovir arm there was one case of breast cancer.Two patients (1.0%) in the BARACLUDE monotherapy arm and seven patients (3.6%) in the BARACLUDE plus tenofovir arm experienced virologic breakthrough. No recognized genotypic resistance mutations were observed in either treatment arm.

About The Study

The BE-LOW study is an open-label, multicenter, Phase IIIb study of 379 nucleos(t)ide-naïve patients with CHB. The patients were randomized 1:1 and treated with either BARACLUDE 0.5 mg once daily (n=182) or BARACLUDE 0.5 mg plus tenofovir 300 mg once daily (n=197). Nucleos(t)ide-naïve, HBeAg-negative CHB patient enrollment was capped at 30%. The primary efficacy endpoint was the proportion of patients with HBV DNA <50 IU/mL at week 96.

About Chronic Hepatitis B

Approximately 350 million people worldwide are chronically infected with hepatitis B (approximately 5% of the world’s population) and 75% of these cases occur in the Asia-Pacific region.(2) Most people with chronic hepatitis B show no signs or symptoms, so many of those chronically infected are unaware of their status. A blood test can diagnose chronic hepatitis B. Patients should speak with their doctor about options available for this condition.

About BARACLUDE®
Discovered at Bristol-Myers Squibb, BARACLUDE® is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:


compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis


decompensated liver disease


For full prescribing information for BARACLUDE®, please consult the Summary of Product Characteristics.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.

BARACLUDE® (entecavir) is a registered trademark of Bristol-Myers Squibb Company.

Contacts:              
Bristol-Myers Squibb
Media: Annie Simond, +33 1 58 83 65 66, annie.simond(at)bms(dot)com

Note:
(1) HBV DNA carries the genetic blueprint of the hepatitis B virus. The number of HBV DNA “copies” found in a person’s blood, or “viral load,” indicates how rapidly the virus is reproducing in their liver. Low levels of HBV DNA, recognized as 300 copies per milliliter or less, indicate an “inactive” hepatitis B infection.

Reference:
(2) Hou J, Liu Z, Gu F. Epidemiology and Prevention of Hepatitis B Virus Infection. Int J Med Sci 2005; 2:50 - 57. Available from http://www.medsci.org/v02p0050.htm Accessed November 2011

MiddleAgeMan

Translation from Google:


第IIIb期博路定®（恩替卡韦）单药治疗与BARACLUDE的加替诺福韦组合的对比表明之间没有统计差异研究武器
•96周的研究，在核苷（酸）IDE天真与慢性乙型肝炎（CHB）感染患者的人口•在美国协会肝病大会在旧金山的研究数据
ShareThis电子邮件PDF打印。旧金山，加州（PRWEB），2011年11月09日

施贵宝公司（纽约证券交易所代码：BMY）今天宣布，从96周的BE -低™研究中，第IIIb期临床试验，比较BARACLUDE的单药治疗（0.5mg的每日一次）与博路定（0.5mg的每日一次）加替诺福韦（300毫克天真与HBeAg阳性和HBeAg阴性慢性乙型肝炎（CHB）与代偿期肝病治疗的成年患者每日一次）。在这项研究中，差异无统计学意义观察到两者之间的治疗武器，在主要疗效终点的HBV DNA <50 IU /毫升（每毫升约300份）（1）在96周：76.4％BARACLUDE的单药治疗手臂并BARACLUDE的加替诺福韦ARM的83.2％（P = 0.0882）。总体而言，无论是研究武器也有类似的安全性。在这项研究中的严重不良事件（SAES）报道在6.6％的患者在BARACLUDE的单药治疗的手臂和7.1％的患者在BARACLUDE的加替诺福韦ARM（197分之14）（一百八十二分之一十二）。这些数据在肝病研究协会第62届年会在旧金山，加利福尼亚（＃223，在总统病毒性肝炎全会提出口头摘要）（AASLD）。

“在这96周的数据，比较恩替卡韦单药治疗恩替卡韦加替诺福韦组合，我们发现，联合治疗没有导致恩替卡韦单药治疗相比，在病毒学应答统计学显著差异。低的BE研究数据证实了以前的研究结果显示有限的或没有治疗慢性乙型肝炎初治患者的单药治疗相比，联合疗法的好处，说：“首席研究员安娜乐，医学博士，FRCP，临床肝脏病学教授和主任在安阿伯密歇根大学医学院的大学内科部。

研究结果

在这项研究中，379核苷（酸）IDE初治慢性乙肝患者被随机要么接受博路定（恩替卡韦）0.5毫克，每天一次（N = 182），或BARACLUDE的0.5 mg加替诺福韦300毫克，每天一次（N = 197）。在96周的主要结果：


一个患者在两个治疗武器相媲美比重达到主要疗效终点的HBV DNA <50 IU / mL的96周：76.4％（182分之139）BARACLUDE的单药治疗手臂和83.2％的BARACLUDE（197分之164）加泰诺福韦臂（P = 0.0882）。
在HBeAg阳性患者HBV - DNA的比例达到<50 IU / mL的69.8％（一百二十六分之八十八）BARACLUDE的单药治疗手臂BARACLUDE的加替诺福韦ARM（138分之111）则为80.4％（P = 0.0460）。进一步的分析表明，这种差异可能是占高基线病毒载量的患者的一个子集。其中HBeAg阳性患者与基线病毒载量<10 ^ 8个国际单位/毫升，83％达到HBV DNA小于50 IU /毫升两种治疗武器（BARACLUDE的单药治疗39/47; BARACLUDE的加替诺福韦五十三分之四十四，P = NS）。然而，与基线病毒载量≥108国际单位/毫升，BARACLUDE的单药治疗手臂的患者62％（49/79）和78.8％（八十五分之六十七）BARACLUDE的加替诺福韦ARM所取得的患者HBV - DNA <50 IU /毫升。
在HBeAg阴性患者中，这一比例实现HBV - DNA <50 IU / mL的91.1％（51/56）和89.8％（53/59）BARACLUDE的加替诺福韦ARM BARACLUDE的单药治疗手臂。

在研究测量的次要疗效终点包括丙氨酸转氨酶（ALT）正常化，HBeAg血清学转换，HBeAg消失。 ALT正常化观察182分之14981.9％的患者在本研究的博路定（恩替卡韦）单药治疗臂与BARACLUDE的加替诺福韦ARM的69％（197分之136）（）。 32.5％的博路定（恩替卡韦）单药治疗臂与BARACLUDE的加替诺福韦的手臂在这项研究中21.7％（138分之30）患者（一百二十六分之四十一）HBeAg血清转换。

BARACLUDE的单药治疗手臂的患者（1.1％）相比，BARACLUDE的加替诺福韦ARM停止治疗96周前5患者（2.5％）。患者停止治疗96周前被认为是治疗失败。

整体不良事件概况，在研究武器类似。一个治疗的患者中，BARACLUDE的加替诺福韦的手臂上，发生3人死亡：因胆管肿瘤;由于这是突破血症相关，而继续治疗肝炎的迟发性发作;因心脏骤停。 1例（0.5％）在BARACLUDE的单药治疗的手臂和经验丰富的治疗ALT突增，定义为大于2 ×基线ALT大于10 x ULN的BARACLUDE的加替诺福韦ARM的2例（1.0％）。在ARM无例（0.0％），经验丰富的治疗的ALT耀斑。 BARACLUDE的单药治疗手臂和四（2.0％）患者在BARACLUDE的加替诺福韦ARM六名病人（3.3％）出现血清肌酐升高≥0.3毫克/升。共有5个恶性肿瘤患者在研究：四个（2.2％）BARACLUDE的单药治疗手臂的患者（0.5％）病人BARACLUDE的加替诺福韦ARM之间发生。在BARACLUDE的单药治疗的手臂，有三个诊断肝癌（两个治疗和一次性处理）和1例胃癌。在BARACLUDE的加替诺福韦手臂有1例乳腺癌。

两名病人在BARACLUDE单药治疗的手臂和BARACLUDE的加替诺福韦ARM 7例（3.6％）（1.0％）出现病毒学突破。没有公认的基因型耐药突变，观察在任一治疗组。

有关研究

低的BE研究是一个开放标签，多中心，第一阶段的IIIb 379核苷（酸）IDE初治慢性乙型肝炎患者的研究。患者随机1:1和治疗或者BARACLUDE 0.5毫克，每天一次（N = 182）或BARACLUDE 0.5 mg加替诺福韦300毫克，每天一次（N = 197）。 IDE -无知的核苷（酸），HBeAg阴性慢性乙型肝炎患者报名上限为30％。主要疗效终点是与HBV DNA的患者比例<50 IU / mL的96周。

关于慢性乙型肝炎

大约3.5亿人全世界都是长期感染与肝炎乙（约5％的人口​​占世界人口的）和这些案件的75％在亚太地区地区的发生。（2）慢性乙型肝炎的大多数人显示没有迹象或症状，所以慢性感染者中的许多人不知道他们的身份。血液检查可以诊断慢性乙型肝炎患者应与医生谈论这个条件的可用选项。

关于博路定®
在百时美施贵宝公司发现，博路定®是用于治疗慢性乙型肝炎病毒（HBV）感染与成人表示：


代偿期肝病和病毒复制活跃，持续升高的血清谷丙转氨酶（ALT）水平和活动性炎症和/或纤维化的组织学证据的证据


失代偿性肝病


博路定®的完整处方信息，请参阅产品特性概要。

关于百时美施贵宝公司

百时美施贵宝公司是一家全球性的生物制药公司，致力于发现，开发并提供创新药物，帮助患者普遍存在较严重的疾病。

博路定®（恩替卡韦）是一种对百时美施贵宝施贵宝公司的注册商标。

联系方式：
百时美施贵宝公司
媒体：安妮Simond，+33 1 58 83 65 66，annie.simond（AT），BMS（点）COM

注意：
（1）HBV - DNA携带乙肝病毒的基因蓝图。 “病毒载量HBV DNA的发现一个人的血液，或”副本“数量”表示，如何迅速的病毒是在其肝脏中繁殖。低层次的HBV DNA，确认为300份，每​​毫升或更少，表示“不活跃”的B型肝炎感染。

参考：
（2）侯J，刘ž，顾流行病学和预防乙型肝炎病毒感染。诠释J医学科学2005年; 2:50 - 57。可访问2011年11月http://www.medsci.org/v02p0050.htm