Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasi

StephenW

http://www.ncbi.nlm.nih.gov/pubmed/22382708
Eur J Gastroenterol Hepatol. 2012 Feb 29. [Epub ahead of print]
Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients.Buti M, Morillas RM, Prietoj M, Diago M, Pérez J, Solà R, Bonet L, Palauj A, Testillano M, García-Samaniego J, Rodríguez M; the ORIENTE Study Group.
SourceaCIBER on Liver and Digestive Diseases (CIBERehd), Hospital Valle Hebrón bCIBER on Liver and Digestive Diseases (CIBERehd), Hospital Universitario Germans Trias i Pujol cHospital del Mar, IMIM, Parc de Salut Mar, Universitat Autònoma de Barcelona, Barcelona dHepatology Section, Digestive Diseases Service, Hospital Universitario y Politécnico La Fe eHospital Universitario General de Valencia, Valencia fHospital Virgen Macarena, Sevilla gHospital Son Espases, Palma hHospital General de Castellón, Castellón iHospital de Cruces, Bizkaia jCIBER on Liver and Digestive Diseases (CIBERehd), Funded by the Instituto de Salud Carlos III, Madrid kHospital Central de Asturias, Oviedo, Spain.

AbstractBACKGROUND: Entecavir is an effective treatment for chronic hepatitis B. However, data from clinical practice are limited, especially in hepatitis B e antigen (HBeAg)-positive patients.
METHODS: We retrospectively analysed data from 190 nucleos(t)ide-naive chronic hepatitis B patients treated with entecavir (0.5 mg/day) in 25 Spanish centres. Virological response (hepatitis B virus DNA <50 IU/ml by PCR), biochemical response (alanine aminotransferase ≤1×upper limit of normal) and serological response were assessed at weeks 12, 24, 36 and 48.
RESULTS: The cohort was 73% male, 84% Caucasian, and 30% HBeAg-positive. Thirty-four per cent of the patients who underwent biopsy had advanced fibrosis/cirrhosis. At baseline, the median hepatitis B virus DNA was 5.94 (interquartile range=4.64-7.39) log10 IU/ml. At week 48, 83% of the patients (61% HBeAg-positive; 92% HBeAg-negative) achieved a virological response and 82% (78% HBeAg-positive; 83% HBeAg-negative) of those with elevated baseline alanine aminotransferase showed a biochemical response. Twenty-six per cent (14/54) of the HBeAg-positive patients lost HBeAg and 22% (12/54) achieved seroconversion to anti-HBe. A significant correlation was observed between virological response at week 12 and the rate of seroconversion to anti-HBe at week 48 (P=0.039). This correlation was also noted at weeks 24, 36 and 48 (P=0.003, 0.002 and 0.017, respectively). Three patients (2%) showed clearance of hepatitis B surface antigen. No resistance to entecavir was observed. Treatment with entecavir was generally well tolerated. No patients discontinued treatment due to adverse events.
CONCLUSION: Entecavir monotherapy in clinical practice was well tolerated and resulted in a rapid and significant reduction in viral load. A virological response at week 12 correlated significantly with the rate of seroconversion to anti-HBe at week 48.

StephenW

欧元胃肠肝胆病杂志。 2012二月29。 [出处提前打印]
恩替卡韦的疗效和安全性在治疗过白人慢性乙型肝炎患者的临床实践。
buti男，莫里利亚斯马币，Prietoj中号，中号瑞金·佩雷斯·J，唯独ŕ，博内特大号，Palauj一个，Testillano中号，加西亚萨马涅戈J·罗德里格斯·中号东方研究小组。
源

肝脏和消化系统疾病（CIBERehd），瓦莱希伯伦bCIBER医院肝脏和消化系统疾病（CIBERehd），医院Universitario德国三叠纪我普霍尔cHospital del Mar的IMIM，PARC DE萨吕月，巴塞罗那自治大学，巴塞罗那dHepatology科，消化aCIBER上疾病的服务，医院UniversitarioŸ都灵理工拉铁eHospital Universitario一般瓦伦西亚，瓦伦西亚fHospital圣女Macarena，的塞维利亚gHospital儿子Espases，帕尔马hHospital·卡斯特利翁将军，卡斯特利翁iHospital·塞斯，：Bizkaia肝脏和消化系统疾病jCIBER（CIBERehd），受资助研究所的Salud的卡洛斯三世，西班牙马德里中央kHospital·阿斯图里亚斯，奥维耶多。
抽象
背景：

恩替卡韦是一种有效治疗慢性乙型肝炎然而，从临床实践中的数据是有限的，尤其是在B型肝炎e抗原（HBeAg）阳性的患者。
方法：

我们回顾分析了来自190个核苷（酸）IDE天真慢性乙型肝炎患者与恩替卡韦（0.5 mg /天）治疗25西班牙中心的数据。病毒学应答（乙肝病毒DNA <50 IU / ml的PCR），生化反应（谷丙转氨酶≤1×正常值上限）和血清学反应进行了评估在12周，24，36和48。
结果：

队列是73％为男性，白人，84％和30％的HBeAg阳性。进行活检晚期肝纤维化/肝硬化患者的百分之三十四个。在基线，中位数的B型肝炎病毒DNA为5.94（四分位距= 4.64-7.39）log10的国际单位/毫升。 48周时，83％的患者（61％的HBeAg阳性; 92％，HBeAg阴性）取得病毒学应答和82％（78％的HBeAg阳性; 83％的HBeAg阴性）的基线丙氨酸升高的转氨酶显示生化反应。 ％的HBeAg阳性患者（14/54）第二十六条失去HBeAg和达到22％（12/54），抗-HBe血清转换。观察12周时的病毒学应答和在第48周（p = 0.039），抗-HBe的血清转换率之间有显着的相关性。也有人指出这种关联在24，36和48周（P = 0.003，分别为0.002和0.017）。三例（2％），表明乙肝表面抗原的清除。没有恩替卡韦的耐药性观察。与恩替卡韦治疗一般耐受性良好。没有患者因不良事件停止治疗。
结论：

恩替卡韦单药在临床实践中的耐受性良好，导致在病毒载量的快速和显着减少。在12周时的病毒学应答与48周时抗-HBe的血清转换率显着相关。

咬牙硬挺

很好的消息