B型肝炎口服核苷治疗的患者血清学转换治低发率在日常实践

StephenW

J Gastroenterol Hepatol. 2012 Dec 27. doi: 10.1111/jgh.12108. [Epub ahead
of print]

Low Incidence of Hepatitis B e Antigen Seroconversion in Patients Treated
with Oral Nucleos(t)ides in Routine Practice.
B型肝炎e抗原血清学转换治疗的患者的低发病率
口服核苷（T）集成开发环境在日常实践中。

Lin B, Ha NB, Liu A, Trinh HN, Nguyen HA, Nguyen KK, Ahmed A, Keeffe EB,
Garcia RT, Garcia G, Nguyen MH.

Source

Pacific Health Foundation, San Jose, CA, USA.

Abstract

BACKGROUND/AIM:

Treatment endpoint of therapy for patients with hepatitis B e
antigen-positive (HBeAg) chronic hepatitis B (CHB) includes HBeAg
seroconversion, which ranges 15-22% after 1 year of oral nucleos(t)ides
according to clinical trials. Our goal was to determine the incidence and
predictors of HBeAg seroconversion in such patients in routine clinical
practice, since it may differ than reported rates.

METHODS:

We conducted a retrospective cohort study of 333 consecutive
treatment-naïve HBeAg-positive patients who were treated for CHB between
1/2000 and 6/2010 at 3 gastroenterology and liver clinics in the United
States. Primary study endpoint was HBeAg seroconversion - loss of HBeAg and
antibody to HBeAg (anti-HBe) development.

RESULTS:

The majority of patients were Asian (96%). Median treatment duration prior
to HBeAg seroconversion was 50 (range, 26-52) weeks. Of the 333 study
patients, 25% received lamivudine (LAM), 16% adefovir (ADV), 51% entecavir
(ETV) and 8% tenofovir (TDF). HBeAg seroconversion at month 12 was 8.2%. On
multivariate analysis inclusive of age, gender and antiviral agents,
independent predictors for HBeAg seroconversion at month 12 were HBV DNA
<7.5 log(10) IU/mL (HR=2.59 [1.04-6.44]), p=0.041) and ALT > 1.5 × upper
normal limit (HR=2.86 [1.05-7.81], p=0.040), but not the choice of
nucleos(t)ides.

CONCLUSIONS:

The HBeAg seroconversion rate seen in clinical settings for oral
nucleos(t)ides appears much lower than those reported in pivotal trials,
especially in those with lower ALT and higher HBV DNA levels.
HBeAg-positive patients should be counseled about the high possibility of
the long treatment duration required to achieve recommended treatment
endpoints.

StephenW

背景/目的：

治疗终点治疗的患者与B型肝炎e
抗原阳性（HBeAg）阳性的慢性乙型肝炎（CHB）包括HBeAg阳性
血清学转换，范围15-22％，1年后的口服核苷（T）集成开发环境
根据临床试验。我们的目标是确定发病率和
在这些患者在常规的临床HBeAg血清学转换的预测
实践中，因为它可能比报道的速率不同。

方法：

我们进行了一项回顾性队列研究的333个连续的
治疗初治的HBeAg阳性患者接受治疗CHB之间
1/2000和6/2010年3胃肠病学和肝病诊所在美国
国。主要研究终点是HBeAg血清学转换 -  HBeAg消失和
抗体，e抗原（抗-HBe）的发展。

结果：

大多数患者为亚洲地区（96％）。平均治疗时间前
到HBeAg血清转换率分别为50（范围26-52）周。 333研究
例患者中，25％的患者接受拉米夫定（LAM），16％的阿德福韦酯（ADV），51％恩替卡韦
（ETV）和8％的替诺福韦（TDF）。在12个月的HBeAg血清学转换率为8.2％。上
多变量分析，包括年龄，性别和抗病毒药物，
在12个月的HBeAg血清转换率分别为HBV DNA的独立预测因子
<7.5日志（10）IU /毫升（HR = 2.59 [1.04-6.44]），P = 0.041）和ALT> 1.5×上
正常上限（HR = 2.86 [1.05-7.81]，p值= 0.040），而不是选择
核苷（酸）集成开发环境。

结论：

HBeAg血清学转换率在临床设置为口服
核苷（酸）IDE的出现大大低于那些在关键的试验报告，
尤其是在那些与降低ALT和HBV DNA水平较高。
HBeAg阳性患者应告知的可能性很高
治疗时间长，需要达到推荐治疗
端点。