DDW2012:Outcomes of Oral Antiviral Treatment for Chronic Hepatitis B (CHB) in Ro

StephenW

Outcomes of Oral Antiviral Treatment for Chronic Hepatitis B (CHB) in Routine Clinical Practice    Sa1043
Mindie H. Nguyen1, Huy N. Trinh2, 3, Huy A. Nguyen2, Khanh K. Nguyen2, Ruel T. Garcia2, Hong Tang4, Brian S. Levitt2, Timothy Juday4                                         
Affiliation
1Division Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA; 2San Jose Gastroenterology, San Jose, CA; 3Pacific Health Foundation, San Jose, CA; 4Bristol-Myers Squibb, Plainsboro, NJ

Abstract:
Purpose: Four approved antiviral oral agents are commonly used to treat chronic hepatitis B (CHB) in the United States: lamivudine (LAM), adeofovir (ADV), entecavir (ETV) and tenofovir (TDF). Current data from clinical registration trials indicated that CHB treatment by these nucleos(t)ide analogues differ in potency and resistance profile. The goals of this study were to examine the treatment outcomes of these agents in a routine clinical care setting.
Methods: Using ICD-9 diagnosis query, 1239 patients who received LAM, ADV, ETV or TDF in two clinics in California between January 2001 and January 2011 were identified. Of these, a total of 957 consecutive patients who received treatment for at least 6 months were included in study analysis.  The median on-treatment follow-up was 42 (6 - 120) months. Study endpoints were complete viral suppression (CVS) rate (defined as having undetectable HBV DNA of < 40-60 IU/mL) and ALT normalization (defined as ALT ≤ 40 U/L) at 6 and 12 months of therapy.
Results: All patients were Asians and predominantly male (65%) with a mean age of 47±13 years. As shown in Figure 1, CVS in treatment naïve patients was similarly low at 6 and 12 months for LAM and ADV (38-44% and 37-50%, respectively), while CVS was similarly high with at the same time points for ETV and TDF (63-63% and 73-79%, respectively). In the subsets of treatment-naïve patients treated with ETV (n=373) or TDF (n=107), these patients were similar in terms of age (45-47 years), sex (61-64% males), hepatitis B e antigen positivity (36-37%), baseline mean HBV DNA levels (6.23±1.51 vs. 6.14±1.56 log10 IU/mL, p=0.55), and baseline median ALT levels (61 [13-839] vs. 51 [8-631] U/L, p=0.52). CVS and Alt normalization rates at 6 and 12 months were also similar in these two groups (Figure 2). Among treatment-experienced patients treated with ETV (n=165) or TDF (n=67), patients treated with ETV had significantly higher mean baseline HBV DNA levels (3.82±2.96 vs. 2.33±2.97 log10 IU/mL, p<0.001) and also higher median baseline ALT (35 [12-880] vs. 29 [9-417] U/L, p=0.07). However, both treatment-experienced groups achieved comparable rates of CVS and ALT normalization (Figure 2). Antiviral resistance was not detected in any of the ETV and TDF treatment cohorts.
Conclusion: In this large cohort of patients treated with various oral antiviral agents for CHB, treatment outcomes were clearly favorable in new agents (ETV and TDF) compared to older agents (LAM and ADV). Among those treated with ETV and TDF, CVS and ALT normalization rates were similar for both treatment-naïve and treatment-experienced. Baseline characteristics of ETV and TDF were similar except for higher HBV DNA and ALT levels among ETV treatment-experienced compared to TDF treatment-experienced patient.
Conclusion: In this large cohort of patients treated with various oral antiviral agents for CHB, treatment outcomes were clearly favorable in new agents (ETV and TDF) compared to older agents (LAM and ADV). Among those treated with ETV and TDF, CVS and ALT normalization rates were similar for both treatment-naïve and treatment-experienced. Baseline characteristics of ETV and TDF were similar except for higher HBV DNA and ALT levels among ETV treatment-experienced compared to TDF treatment-experienced patient.

Figure 1. Complete viral suppression rates of treatment-naïve patients at 6 and 12 months with  lamivudine (LAM), adefovir (ADV), entecavir (ETV), and tenofovir (TDF).

Figure 2.Treatment outcomes of entecavir (ETV) and tenofovir (TDF) treatment groups, by prior treatment status.

                             
                                       

Figure 1. Complete viral suppression rates of treatment-naïve patients at 6 and 12 months with  lamivudine (LAM), adefovir (ADV), entecavir (ETV), and tenofovir (TDF).

Figure 2.Treatment outcomes of entecavir (ETV) and tenofovir (TDF) treatment groups, by prior treatment status.

                             
Disclosure(s):
Mindie H. Nguyen - Advisory Committees or Review Panels: Salix Pharmaceuticals, Schering-Plough, Schering-Plough, Vertex Pharmaceuticals , Three Rivers Pharmaceuticals, LLC; Grant/Research Support: Gilead Sciences, Romark Laboratories; Speaking and Teaching: Bristol-Myers Squibb, Gilead Sciences, Hoffman-LaRoche
Huy N. Trinh - Advisory Committees or Review Panels: Bristol-Myers Squibb, Bristol-Myers Squibb, Gilead Sciences Inc; Grant/Research Support: Gilead Sciences; Stock Shareholder: Gilead Sciences, Bristol-Myers Squibb
Huy A. Nguyen - Speaking and Teaching: Gilead Sciences Inc
Hong Tang - Employment: Bristol-Myers Squibb Co.
Timothy Juday - Employment: Bristol-Myers Squibb Co.
The following people have nothing to disclose: Khanh K. Nguyen, Ruel T. Garcia, Brian S. Levitt

StephenW

口服抗病毒药物治疗慢性乙型肝炎（CHB）在日常临床实践Sa1043 | Mindie H.的Nguyen1，伊北Trinh2，3，伊答Nguyen2，庆光Nguyen2，鲁埃尔吨Garcia2，香港Tang4，布赖恩小号的成果。蒂莫西Juday4（Levitt2，）

打印尔
1区，胃肠病学和肝病，斯坦福大学医学中心，帕洛阿尔托，加利福尼亚圣何塞2San消化科，加利福尼亚州圣何塞，加利福尼亚州圣何塞，3Pacific健康基金会，4Bristol-Myers Squibb公司，新泽西州Plainsboro的，

摘要：

目的：四份抗病毒药物口服制剂常用于治疗慢性乙型肝炎（CHB）在美国：拉米夫定（LAM），adeofovir（ADV），恩替卡韦（ETV）和替诺福韦（TDF的）。目前从临床注册试验数据表明，这些核苷（酸）IDE类似物治疗慢性乙型肝炎的效力和耐药性不同。这项研究的目标是在一次例行的临床护理设置检查这些药物的治疗效果。
方法：使用的ICD-9诊断查询，1239例2001年1月至2011年1月获得在加利福尼亚州的两个诊所议员，ADV，ETV或TDF进行了鉴定。这些研究分析，共纳入957例患者接受至少6个月的治疗。治疗随访中位数为42个月（6  -  120）。研究终点是完整的病毒抑制（CVS）的速度在6至12个月的治疗和ALT正常化（ALT≤40 U / L，定义）（定义为检测不到乙肝病毒DNA <40-60 IU / mL的）。
结果：所有患者的平均年龄47±13岁的亚洲人和以男性为主（65％）。正如图1所示，在初治患者治疗CVS同样是LAM和ADV（38-44％和37-50％），分别在6至12个月低，在相同的时间点为ETV同样高的，而CVS的和TDF（63-63％和73-79％，分别）。在ETV（N = 373）或TDF的治疗治疗过的患者亚群（N = 107），这些患者在年龄上的相似（45-47岁），性别（男性61-64％），B型肝炎e抗原阳性（36-37％），基线平均HBV DNA水平（6.23±1.51比6.14±1.56 log10的国际单位/毫升，P = 0.55），基线ALT水平的中位数（61 [13-839]与51 [ 8-631]的U / L，P = 0.52）。在6个月和12个月的CVS和ALT复常率也相似，在这两个群体（图2）。在ETV（N = 165）或TDF的治疗治疗经验的患者（N = 67），与ETV治疗的患者有显着较高的平均基线HBV DNA水平（3.82±2.96比2.33±2.97 log10的国际单位/毫升，P <0.001 ）和基线ALT中位数也较高（35 [12-880]与29 [9-417]的U / L，P = 0.07）。然而，无论是经验丰富的治疗组取得可比CVS和ALT正常化率（图2​​）。任何ETV和TDF治疗同伙中没有检测到病毒抗药性。
结论：在此大型队列各种口腔慢性乙型肝炎抗病毒药物治疗的患者，治疗效果显然是有利的新的代理商（ETV和TDF）较旧的代理商（LAM和ADV）。ETV和TDF治疗的人群中，CVS和ALT复常率分别为类似的治疗天真和治疗经验。ETV和TDF的基线特征相似，除了较高的HBV DNA和ALT水平之间的ETV治疗经验相比，TDF的治疗经验的患者。

图1。完整的病毒抑制率与拉米夫定（LAM），阿德福韦（ADV），恩替卡韦（ETV），替诺福韦（TDF）在6至12个月的治疗初治患者。

图恩替卡韦（ETV）和替诺福韦（TDF）治疗组2.Treatment成果，由治疗前的状态。


披露（S）：
mindie H.阮 - 咨询委员会或审查小组：Salix制药公司，先灵葆雅，先灵葆雅，Vertex制药，三河制药有限责任公司;格兰特/研究支持：Gilead Sciences公司，Romark实验室;演讲及教学：施贵宝，Gilead Sciences公司，霍夫曼 - 拉罗什
伊北郑氏 - 咨询委员会或审查小组：施贵宝公司，施贵宝，吉利德科学公司;格兰特/研究支持：Gilead Sciences公司股票股东：Gilead Sciences公司，施贵宝
伊答：阮 - 口语和教学领域：吉利德科学公司
香港唐 - 就业：施贵宝公司
霍震霆Juday  - 就业：施贵宝公司
下面的人有没有透露：K.阮庆鲁埃尔T.加西亚，布赖恩与莱维特

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