AASLD 2011: Off therapy durability in chronic hepatitis B e antigen negative pat

StephenW

Off therapy durability in chronic hepatitis B e antigen negative patients treated with entecavir
W. Jeng1; I. Sheen1; Y. Chen1; C. Chu1; C. Hsu1; R. Chien1; Y. Liaw1
1. Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.


Background:
The optimal duration of nucelos(t)ide analoge (NA) treatment in chronic hepatitis B e antigen (HBeAg) negative patients is unknown. APASL guidelines suggest that treatment discontinuation can be considered if undetectable HBV-DNA has been documented on three occasions 6 months apart.

Aim:
To validate the APASL NA stopping rule in chronic HBeAg-negative patients treated with Entecavir (ETV).

Method:
After discontinuation of ETV monotherapy with three undetectable HBV DNA 6 months apart, 79 patients had a follow-up of 6 months and 61 patients had a follow-up of 1 year. They were monitored with serum HBV DNA and ALT at least every 3 month. Age, gender, HBV genotype/natural mutations cirrhosis, prior treatment, baseline ALT, bilirubin, prothrombin time, HBV DNA undetectable within 3 months, ALT normalization within 3 months, treatment duration, and consolidation duration (after HBV DNA undetectable) were analyzed. The definition of relapse was any ALT > 2X plus HBV-DNA >104copies/mL (2000IU/mL), which is the APASL indication of drug therapy for HBeAg-negative patients. Serum HBV-DNA was measured by a PCR assay (Cobas Taqman HBV Monitor, Roche Diagnostics, Pleasanton, California; lower limit of detection: 69 copies or 12 IU/mL)

Result:
Of the 79 patients with 6-months follow-up, 22 patients (27.8%) relapsed. Of the 62 patients with 1-year follow-up, 33 patients (53.2%) relapsed. The mean duration till relapse was 160.1±29.5 days. Of the factors included in the analyses, pre-treatment HBV-DNA <106copies/mL(2x105 IU/mL) is the only independent factors for 1-year sustained response. For those with baseline HBV DNA <106 copies/mL, only 28.5% relapsed in one year.

Conclusion:
With an 1-year relapse rate of 28.5 % in chronic HBeAg-negative patients with serum HBV DNA <106copies/mL(2x105 IU/mL), the APASL stopping rule seems appropriate, especially for patients from regions where cost/reimburse is a concern.

StephenW

停止治疗后与恩替卡韦治疗慢性乙型肝炎发送抗原阴性患者的耐久性
W.政1 1一辛; Y.陈1; C.储1; C.许1; R.建1; Y.廖1
1。肝研究组，长庚医院，长庚大学医学张，台北，台湾。


背景：
nucelos（T）IDE analoge（NA）治疗慢性乙型肝炎e抗原（HBeAg）阴性患者的最佳时间是未知的。 APASL指南建议，可以考虑停药，如果检测不到HBV - DNA已被记录三次相隔6个月。

目的：
为了验证在用恩替卡韦（ETV）治疗慢性HBeAg阴性患者的APASL NA停止规则。

方法：
停止教育电视单药治疗与检测不到乙肝病毒DNA相隔6个月后，79例患者6个月的后续，61例患者1年的后续行动。他们进行了监测与血清HBV DNA和ALT至少每3个月。年龄，性别，HBV基因型/自然突变肝硬化，治疗前，基线ALT，胆红素，凝血酶原时间，HBV - DNA检测不到3个月内3个月内，谷丙转氨酶正常化，治疗时间和巩固期（后HBV - DNA检测不到）进行了分析。复发的定义是任何ALT> 2X加的HBV - DNA> 104copies/mL（2000IU/mL），这是药物治疗的HBeAg阴性患者APASL指示。血清HBV - DNA测定的PCR检测（COBAS TaqMan探针HBV监视器，罗氏诊断，加利福尼亚州普莱森顿，更低的检测限：69份或12 IU / mL的）

结果：
后续6个月的79例患者，22例（27.8％）复发。 1年随访的62例，复发33例（53.2％）。直到复发的平均时间为160.1 ± 29.5天。在分析中包含的因素，治疗前HBV - DNA <106copies/mL（2x105国际单位/毫升）仅1年持续应答的独立因素。对于那些与基线HBV DNA <106拷贝/ ml，只有28.5％在一年内复发。

结论：
有28.5％的1年复发率在慢性HBeAg阴性患者血清HBV DNA <106copies/mL（2x105国际单位/毫升），APASL停止规则似乎是恰当的，尤其是对地区在成本/偿还患者是一个问题。

把握当下

e抗原阴性乙肝临床患者恩替治疗后停药效果

背景：e抗原阴性乙肝临床患者核苷治疗效果持续时间尚未可知。APASL指南建议如果HBV-DNA连续3次检查、每次间隔6个月都是阴性可以停药。

目标：验证使用恩替治疗的e抗原阴性乙肝临床患者是否符合APASL核苷停药规则。

方法：使用恩替单药治疗，HBV-DNA连续3次检查、每次间隔6个月都是阴性时停药，79名患者随访半年，61名患者随访1年。这些患者血清HBV DNA和ALT至少三个月检查一次。年龄，性别，HBV基因型/自然变异硬化（natural mutations cirrhosis），治疗史，ALT基线，胆红素，凝血时间，3个月内HBV DNA检测不到并且ALT正常，治疗时间，HBV DNA检测不到后继续吃药巩固时间都是分析因素。复发定义为：ALT大于两倍正常值并且HBV-DNA >104copies/mL (2000IU/mL)
，这是APASL对药物治疗e抗原阴性患者的说明。血清HBV-DNA使用PCR assay方法 (Cobas Taqman HBV 检测器，Roche诊断工具, Pleasanton, California; 检测底线：69 copies或12 IU/mL)

结果：进行6个月随访的79名患者中，22人 (27.8%) 复发。1年随访的62名患者中，33人(53.2%) 复发。表明停药到复发大概相距160.1±29.5天。根据分析，治疗前HBV-DNA <106copies/mL(2x105 IU/mL)对保持1年效果来说是唯一的独立指示：对于HBV DNA <106 copies/mL基线的患者来说，只有28.5%在1年内复发。

结论：血清HBV DNA <106copies/mL(2x105 IU/mL)、e抗原阴性乙肝临床患者停药1年复发率为28.5 %，APASL停药规则貌似靠谱，对费用敏感患者而言很有用处。