AASLD2016[1846]恩替卡韦和替诺福韦的疗效比较

StephenW

1846
Comparison of the efficacy of entecavir and tenofovir
monotherapy for the treatment of treatment -naïve
patients with hepatitis B virus
Young Kul Jung1, Hyung Joon Yim1, Sang Jun Suh1, Oh Sang
Kwon2, Yun Soo Kim2, Duck Joo Choi2, Ju H. Kim2; 1Korea Univ.
Ansan Hosiptal, Ansan, Korea (the Republic of); 2Internal Medicine,
Gachon Univ. Gil hospital, Incheon, Korea (the Republic of)
Backgrounds: Current treatment guidelines recommend either
entecavir (ETV) or tenofovir (TDF) as first line treatment for management
of chronic hepatitis B patients given their high antiviral
potency, favorable tolerability profile, and high genetic
barriers to the development of antiviral resistance. However,
it is not clear whether the efficacy reported from head-to-head
trial is similar to the outcomes seen in routine practice. Aim
: Our aim is to investigate the treatment outcomes of antiviral
therapy in a clinical practice. Methods: We conducted a
prospective cohort study of 130 treatment-naïve patients who
started either ETV or TDF by randomization manner between
Januanry 2013 and December 2014. Primary endpoint was
complete viral suppression rate (HBV DNA real-time PCR <
20 IU/mL) at 12 month after treatment. Results: Total 130
CHB patients were enrolled and randomized in both group.
However, 15 patients were dropped by any lesion and 104
patients (80%) were remain at 12 months. The majority of
patients in both ETV and TDF group were male (73%), HBeAg
negative (60%), and non-cirrhotic patients (52%). Pretreatment
serum ALT, HBV DNA level, bilirubin, and albumin level were
similar between two groups (p=n.s.). At treatment 12 months,
both group achieved similar complete virological response:
85% vs. 86%, respectively (p=0.26). Biochemical response
is also similar: 95% vs. 96%, respectively (p=0.3). Among
HBeAg positive patients, 6 patients showed HBeAg loss ( 2
patients in ETV, 4 in TDF) and 2 patients achieved HBeAg
seroconversion (1 at ETV, 1 at TDF). 3 patients experienced
side effect and stopped medication (1 at ETV, 2 at TDF). However,
there was no serious side effect during treatment period.
Conclusions: Treatment-naïve CHB patients treated with either
ETV or TDF achieved a similar rate of complete virological and
biochemical response at 12 months. However, drop rate was
slightly high regardless of drug and attention to medication
adherence is needed in a clinical practice.
Disclosures:
The following people have nothing to disclose: Young Kul Jung, Hyung Joon Yim,
Sang Jun Suh, Oh Sang Kwon, Yun Soo Kim, Duck Joo Choi, Ju H. Kim

StephenW

AASLD2016 [1846]恩替卡韦和替诺福韦的疗效比较
恩替卡韦和替诺福韦的疗效比较
单一疗法治疗的疗法
乙型肝炎病毒患者
Young Kul Jung1，Hyung Joon Yim1，Sang Jun Suh1，Oh Sang
Kwon2，Yun Soo Kim2，Duck Joo Choi2，Ju H.Kim2; 1Korea Univ。
安山Hosiptal，安山，韩国（共和国）; 2内科，
Gachon Univ。吉尔医院，仁川，韩国（共和国）
背景：当前治疗指南推荐
恩替卡韦（ETV）或替诺福韦（TDF）作为一线治疗
的慢性乙型肝炎患者给予高抗病毒治疗
效力，有利的耐受性分布和高遗传
阻碍抗病毒抗性的发展。然而，
尚不清楚是否从头到头报告了疗效
试验与常规实践中观察到的结果相似。目标
：我们的目的是调查抗病毒治疗的结果
治疗在临床实践中。方法：
前瞻性队列研究130例初治患者
通过之间的随机化方式开始ETV或TDF
Januanry 2013年和2014年12月。主要终点是
完全病毒抑制率（HBV DNA real-time PCR <
20 IU / mL）。结果：共130
CHB患者入组并随机分入两组。
然而，15名患者被任何病变丢弃，104
患者（80％）保留在12个月。多数的
ETV和TDF组的患者均为男性（73％），HBeAg
阴性（60％）和非肝硬化患者（52％）。预处理
血清ALT，HBV DNA水平，胆红素和白蛋白水平
两组之间相似（p = n.s。）。治疗12个月，
两组均达到类似的完全病毒学应答：
85％对86％（p = 0.26）。生化反应
也是类似的：分别为95％对96％（p = 0.3）。其中
HBeAg阳性患者，6例显示HBeAg消失（2
ETV患者，TDF 4例），2例获得HBeAg
血清转换（1个在ETV，1个在TDF）。 3例患者经历
副作用并停止用药（1例在ETV，2例在TDF）。然而，
治疗期间无严重副作用。
结论：治疗初始CHB患者治疗
ETV或TDF达到类似的完全病毒学率
12个月的生化反应。但是，掉率是
略高，不管药物和注意用药
在临床实践中需要粘附。
披露：
以下人士没有透露：Young Kul Jung，Hyung Joon Yim，
Sang Jun Suh，Oh Sang Kwon，Yun Soo Kim，Duck Joo Choi，Ju H.Kim