EASL2012:GENOTYPIC RESISTANCE REDUCED TO VERY LOW LEVELS IN CHRONIC HEPATITIS B

StephenW

Abstract               
                                

Title	GENOTYPIC RESISTANCE REDUCED TO VERY LOW LEVELS IN CHRONIC HEPATITIS B (CHB) PATIENTS TREATED OVER 2-YEARS WITH TELBIVUDINE (LDT) WHEN CONSIDERING BASELINE CHARACTERISTICS AND ROADMAP
Speaker:	Fabien   Zoulim
Author:	F. Zoulim1*, S. Zeuzem2, T. Piratvisuth3, H.L. Chan4, J. Hou5, J. Jia6, S. Bosset7, A. Uddin8, Y. Dong7, A. Trylesinski7
Affiliation:	1Head of Viral Hepatitis Research Team, INSERM, Lyon, France, 2Klinikum der Johann-Wolfgang-Goethe-Universitaet, Frankfurt am Main, Germany, 3NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Bangkok, Thailand, 4Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong S.A.R., 5Southern Medical University, Guangzhou, 6Beijing Friendship Hospital, Beijing, China, 7Novartis Pharma, AG, Basel, Switzerland, 8Novartis Pharmaceuticals, East Hanover, NJ, USA. *[email protected]
Background: Baseline HBV DNA, ALT levels and Week 24 HBV DNA levels predict resistance during CHB treatment. Methods: In LDT treated patients in GLOBE study, resistance rates were assessed at 1 and 2-years in patients with defined baseline characteristics (HBeAg-positive patients with HBV DNA < 9 log10 copies/ml, ALT ≥2×ULN; HBeAg-negative patients with HBV DNA < 7 log10 copies/ml) and undetectable week 24 HBV DNA. Results:
	HBeAg-positive		HBeAg-negative
Year 1 / Week 52	N=57		N=86
Undetectable serum HBV DNA	96.5%		97.7%
HBeAg seroconversion	39.6%		-
Genotypic resistance	0%		0%
	Subgroup analysis*	Mathematical model**	Subgroup analysis*	Mathematical model**
Year 2 / Week 104	N=57	N=55	N=86	N=84
serum HBV DNA	89%	90.9%	91%	92.9%
HBeAg seroconversion	52%	53.2%	-	-
Cumulative genotypic resistance	1.8 %	1.8 %	2.3 %	2.4 %

* Sub-group analysis as defined in methods.**Patients with PCR-negative at the beginning of year 2 included, per the mathematical model by Pawlotsky .
Conclusion: In patients with defined baseline characteristics and undetectable week 24 HBV DNA, no resistance after 1 year was reported. 2-year resistance is very low.               

StephenW

标题基因型耐药减少到慢性乙型肝炎（CHB）患者非常低的水平超过2年的治疗替比夫定（LDT中）时，考虑的基线特征和路线图
主讲人：法比安斯基Zoulim
作者：楼Zoulim1 S. Zeuzem2，T. Piratvisuth3，红莲Chan4，Hou5研究，研究Jia6，S. Bosset7，A Uddin8，华Dong7，Trylesinski7答
单位：1Head病毒性肝炎研究小组，（INSERM），法国里昂，2Klinikum DER，美因河畔法兰克福约翰 - 沃尔夫冈 - 歌德综合大学，德国，3NKC胃肠病学研究所和肝病，Songklanagarind医院，曼谷，泰国，4Department内科及药物治疗，中国香港，香港，香港特区，广州5Southern医科大学，友谊医院6Beijing，北京，中国，7Novartis制药公司，瑞士巴塞尔，，8Novartis制药，东汉诺威，新泽西州，美国的大学。 * fabien.zoulim @ inserm.fr
背景：基线HBV DNA，ALT水平和24周HBV DNA水平预测在慢性乙型肝炎治疗的抵抗。
方法：在治疗的LDT GLOBE研究的患者进行了评估，耐药率在1和2年的患者定义的基线特征（HBeAg阳性患者与HBV DNA <9 log10拷贝/毫升，ALT≥2×ULN的HBeAg阴性乙型肝炎病毒DNA <7 log10拷贝/毫升），不到24周时HBV DNA的患者。
结果：

HBeAg阳性，HBeAg阴性
今年1 /周52 n = 57 n = 86
检测不到血清HBV DNA 96.5％97.7％
HBeAg血清转换的39.6％ -
基因型耐药0％0％
亚组分析*数学模型**小组分析的数学模型**
今年2 /周104 n = 57 n = 55 N = 86 n = 84
血清HBV DNA 89％90.9％92.9％91％
HBeAg血清转换52％，53.2％ -
累计基因型耐药1.8％1.8％2.3％2.4％
[表]


小组分析方法定义。** PCR阴性患者在第2年开始每Pawlotsky医师数学模型，。
结论：在定义的基线特征和不到24周时HBV DNA的，不产生抗药性的患者1年后报告。 2年的阻力是非常低的。

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