[AASLD 2012]比较拉米夫定，阿德福韦酯，替比夫定和恩替卡韦

肝胆速递

拉米夫定，阿德福韦酯，替比夫定和恩替卡韦治疗慢性HBV感染者的NAS初治患者的疗效情况比较：4年现实生活中的数据
CONTROL ID: 1425836
PRESENTATION TYPE: Oral or Poster
CURRENT CATEGORY: Hepatitis B
CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials
TITLE: Comparation of the efficacy of lamivudine, adefovir dipivoxil, telbivudine and entecavir in treating NAs-naive patients with chronic HBV infection: 4-year real life data
AUTHORS (FIRST NAME, LAST NAME): Yuankai Wu1, Xiangyong Li1, Guoli Lin1, Jie Luo1, Hong Shi1, Yusheng Jie1, Tingting Xiong1, Xiao Zhang1, Xiujuan Zhang1, Liuqing Yang1, Yihua Pang1, Yunlong Ao1, Yutian Chong1, Zhiliang Gao1
Institutional Author(s):
INSTITUTIONS (ALL): 1. Department of Infectious Diseases , the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
ABSTRACT BODY: Background: Pivotal trials of lamivudine, adefovir dipivoxil, telbivudine and entecavir have provided us clinical data about safety and efficacy for each. However, these data are from study subjects who were strictly selected, clinical data from pivotal trials may not be consistent with data obtained in real life. This study aimed to investigate the effectiveness of these four nucleos(t)ide analogs(NAs) monotherapy in naïve patients chronicly infected with HBV in real life practice.
Methods: This retrospective and prospective cohort study investigated 415 NAs naive patients with chronic hepatitis B(CHB) or HBV-related cirrhosis(CIR) ongoing lamivudine(LAM), adefovir dipivoxil(ADV), telbivudine(LDT) or entecavir(ETV) monotherapy in our follow-up clinic during Jan. 2005 and Dec. 2011. The effectiveness data of the four NAs in real-life were collected and analyzed. HBV DNA was quantified by real-time PCR (Da an Genetics, lower limits of detection: 100IU/ml).
Results: In all patients (aged 39±11.8years, CHB/CIR=312/103), 19% lost during follow-up. The median duration of antiviral therapy is 24.0 (3-107.2)months. The baseline ALT, AST, TBil were comparable. The baseline HBV DNA load in ADV group were lower than the other groups (P<0.005), which of the other three groups were comparable. The undetectable rate of serum HBV DNA (<100IU/ml) in four groups were statistically different at 1st, 2nd and 3rd year (ETV>ADV>LDT>LAM, P≤0.007) and was comparable at 4th year. At the end of follow-up, the rates of complete viral response(CVR)(42.9%-92.6%, ETV>ADV>LDT>LAM, P<0.001) and viral breakthrough(VBT)(44.0%-4.6%, LAM>LDT>ADV>ETV, P<0.001) were statistically different. However, the HBeAg seroconversion rates were comparable (16.5%-23.4%, P=0.722). (See the Table)
Conclusions: Entecavir monotherapy have a higher undetectable rate of serum HBV DNA and lower viral breakthrough in NAs naive patents with CHB or CIR, when compared to telbivudine, adefovir and lamivudine.

	LAM (n=91)	ADV (n=126)	LDT (n=45)	ETV (n=153)	Total (n=415)	Statistics	P
Duration of antiviral therapy(Months)	25.1	23.7	19.4	24.9	24.0	F=1.64	0.180
Baseline HBV DNA (log10 IU/ml)	6.26±1.72	5.38±1.45	6.27±1.67	6.06±1.40	5.92±1.56	F=8.11	<0.001
Rates of undetectable HBV DNA(%)
1st Y	42.4	72.3	69.7	87.4	71.9	χ2=43.54	<0.001
2nd Y	70.6	84.7	76.5	94.6	85.3	χ2=12.20	0.007
3rd Y	71.4	95.5	100.0	100.0	91.8	/	0.002*
4th Y	78.6	85.7	100.0	100.0	88.2	/	0.330*
CVR at end(%)	42.9	70.6	62.2	92.8	71.8	χ2=93.49	<0.001
VBT at end(%)	44.0	19.8	31.1	4.6	20.7	χ2=57.20	<0.001
HBeAg seroconversion at end(%)	17.9	16.0	22.9	23.4	20.2	χ2=1.37	0.722

*: Fisher’s exact test, no statistics available.

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肝胆速递

背景：拉米夫定，阿德福韦酯，替比夫定和恩替卡韦的临床试验已经为我们提供了为每个安全性和有效性的临床资料。然而，这些数据是从研究对象，进行了严格的选择，关键试验的临床数据可能无法在现实生活中获得的数据相一致。本研究旨在探讨这些IDE四种核苷（酸）类似物（NAS）单药治疗初治患者chronicly感染乙肝病毒的，在现实生活中实践的有效性。
方法：本回顾性和前瞻性队列研究调查了415港定居慢性乙型肝炎（CHB）或HBV相关性肝硬化（CIR）正在进行的拉米夫定（LAM），阿德福韦酯（ADV），替比夫定（LDT）或恩替卡韦（ETV）单药治疗初治患者我们在2005年1月和2011年12月的随访门诊。在现实生活中的四个来港定居的有效性的数据收集和分析。 HBV-DNA的定量实时PCR（沓遗传学的检测下限：100IU/ml）。
结果：在所有患者（39岁±11.8年，CHB / CIR =一百○三分之三百十二），在随访过程中损失19％。抗病毒治疗的中位时间为24.0个月（3-107.2）。基线ALT，AST，总胆红素是相当的。 ADV组的基线HBV DNA载量低于其他各组（P <0.005），其他三组比较。无法检测率四组的血清HBV DNA（<100IU/ml）在第1，第2和第3年（ETV ADV> LDT林，P≤0.007），差异有统计学意义，并在4年相媲美。在年底跟进，完整的病毒反应（CVR）率（42.9％-92.6％，ETV ADV LDT林，P <0.001）和病毒的突破（VBT）（44.0％-4.6％，林> LDT> ADV> ETV，P <0.001），差异有统计学意义。然而，HBeAg血清转换率相当（分别为16.5％-23.4％，P = 0.722）。 （见表）
结论：恩替卡韦单药治疗有较高的血清HBV DNA检测不到率和较低的病毒突破的NAS CHB或CIR，天真的专利相比，替比夫定，阿德福韦酯，拉米夫定。

lzwp

看起来还是恩替卡韦好哇！