DDW:Entecavir & Adefovir in HBeAg-ve patients

StephenW

Abstract:	Su1013 Year: 2011
	Title:	Long-Term Treatment Response to Entecavir and Adefovir in Treatment-NaïVE Chronic Hepatitis B E Antigen-Negative Patients in a Community Setting
	Author:	Vincent G. Nguyen1, Nghiem  B. Ha3, 1, Nghi  B. Ha1, Huy N. Trinh2, 1, Huy A. Nguyen2, Khanh K. Nguyen2, Ruel T. Garcia2, 1, Brian S. Levitt2, Mindie H. Nguyen3
	Topic:	Viral Hepatitis
	Abstract:	Purpose: The efficacy and tolerability of entecavir (ETV) and adefovir (ADV) in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients are well defined through clinical registration trials. However, patients selected for these studies may differ from patients seen in community settings. The purpose of this study was to examine the long-term response of HBeAg-negative patients treated with ETV or ADV in a community clinical setting. Methods: We conducted a retrospective study of 189 consecutive treatment-naïve HBeAg-negative patients who started treatment with either ETV 0.5 mg daily (n=107) or ADV 10 mg daily (n=82) at two community-based GI clinics between 1/02 and 1/09. Patients were excluded from further analysis if they developed resistance (n=11), required alternative therapy (n=27), were nonadherent (n=13), or lost to follow-up (n=14). Complete viral suppression (CVS) was defined as undetectable HBV DNA PCR levels (<100 IU/mL). Results: All patients were Asian, with the majority being male (75%-78%) with a mean age of 52±11 years. Prior to therapy, both the ETV and ADV cohorts had similar median HBV DNA (5.6 [2.0-8.2] vs. 5.5 [3.2-8.5] log10 IU/mL, p=0.45) and median ALT (62 [12-1237] vs. 77 [10-673] U/L, p=0.92). Patients treated with ADV had longer median follow-up duration (42 [12-72] vs. 36 [12-48] months, p=0.03). Higher proportion of patients in the ETV cohort achieved CVS through year 1 (91% vs. 70%, n=107,82), year 2 (96% vs. 80%, n=99,74), year 3 (99% vs. 88%, n=78,58), and year 4 (96% vs. 91%, n=46,44). Although similar proportions of patients from both cohorts achieved CVS by year 4, more patients in the ADV cohort required alternative therapy (27% vs. 5%, p<0.0001). Reasons for initiating alternative therapy in the ADV cohort included suboptimal response (n=8), virologic breakthrough without confirmed genotypic resistance (n=4), confirmed ADV resistance (n=8), and renal insufficiency (n=2). In the ETV cohort, initiation of alternative therapy was only due to suboptimal response (n=5). By year 4, cumulative rate of genotypic resistance in the ADV cohort was 18% compared to 0% in the ETV cohort. Cumulative nonadherence rate were similar in both cohorts (10%-12%). Two (2) patients achieved hepatitis B surface antigen loss at year 4 with ADV. Conclusion: Failure to monotherapy in a community clinical setting is due to both genotypic resistance and patient nonadherence. Attention to medical adherence in addition to genotypic resistance surveillance is needed in community settings.
	Disclosure:	Huy N. Trinh - Advisory Committees or Review Panels: Bristol-Myers Squibb, Bristol-Myers Squibb, Gilead Sciences Inc; Grant/Research Support: Gilead Sciences, Roche; Stock Shareholder: Gilead Sciences, Bristol-Myers Squibb Huy A. Nguyen - Speaking and Teaching: Gilead Sciences Inc Mindie H. Nguyen - Consulting: Gilead Sciences Inc, Bristol-Myers Squibb Co. , Bayer AG; Grant/Research Support: Bristol-Myers Squibb Co. , Novartis Pharmaceuticals, Roche Pharma AG The following people have nothing to disclose: Vincent G. Nguyen, Nghiem B. Ha, Nghi B. Ha, Khanh K. Nguyen, Ruel T. Garcia, Brian S. Levitt

StephenW

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StephenW

谷歌翻译不是100％准确，仅供参考。

目的：的疗效和耐受性，恩替卡韦（ETV）和阿德福韦在乙型肝炎e抗原（ADV），e抗原（HBeAg）阴性慢性乙型肝炎（CHB）患者通过临床注册试验的定义。然而，这些研究入选患者，在社区环境中看到的患者可能不同于。这项研究的目的是研究在社区临床与教育电视或ADV治疗HBeAg阴性患者的长期反应。

方法：我们进行了189连续治疗初治的HBeAg阴性患者要么ETV 0.5毫克，每日（N = 107）或ADV 10毫克，每日（N = 82）开始在两个社区为基础的1胃肠道间诊所治疗的回顾性研究/ 02和1 / 09。患者均排除进一步分析，如果他们开发的电阻（N = 11），所需的替代疗法（N = 27），nonadherent（N = 13），或失去后续（N = 14）。完整的病毒抑制（CVS）的定义为检测不到乙肝病毒DNA PCR检测水平（<100 IU / mL）的。

结果：所有患者均亚洲，其中大部分是一个平均年龄52 ± 11岁的男性（75％-78％），。治疗前，ETV和ADV同伙类似的中位数HBV - DNA（5.6 [2.0-8.2]与5.5 [3.2-8.5] LOG10 IU / mL时，P = 0.45）和中位数的ALT（62 12-1237 VS 77 [10-673] U / L，P = 0.92）。与ADV治疗的患者有较长的中位数的后续行动的持续时间（42 [12-72]与36个月[12-48]，P = 0.03）。在教育电视的队列患者比例更高取得CVS通过1年（91％比70％，N = 107,82），2年（96％与80％，N = 99,74），第3年（99％比88％，N = 78,58），和今年4（96％与91％，N = 46,44）。虽然类似的两个同伙的病人的比例实现4年的CVS，在ADV队列需要更多的患者替代疗法（27％和5％，P <0.0001）。开始在ADV队列替代疗法的原因包括不理想的反应（N = 8），未经证实的基因型耐药（N = 4）的病毒学突破，证实ADV阻力（N = 8），和肾功能不全（N = 2）。在教育电视的队列，开始替代疗法只是由于不理想的反应（N = 5）。第4年，在ADV队列累计基因型耐药率18％相比，在教育电视队列0％。累积nonadherence率分别为两个组群（​​10％-12％）相似。两（2）在今年4例，取得了与ADV乙肝表面抗原损失。

结论：单药治疗在社区临床失败是由于基因型耐药病人nonadherence。需要注意除了基因型耐药监测医疗坚持是在社区环境。