Telbivudine associated HBsAg Loss after 3 years' treatment

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HBsAg Loss

K. Wursthorn and colleagues looked at the kinetics of hepatitis B surface antigen decline among 172 HBeAg positive GLOBE participants with undetectable HBV DNA (< 300 copies/mL) after 2 years on telbivudine, who continued taking the drug during the extension study described above.

HBsAg clearance is the ultimate goal of antiviral treatment for chronic hepatitis B, the investigators noted as background. Measuring HBsAg may help predict the timing and probability of this favorable outcome. In this analysis, serum HBsAg levels were measured at baseline, at treatment week 24 in the original GLOBE study, and at years 1, 2, and 3.

Results

Serum HBsAg levels declined progressively during 3 years on telbivudine.

Telbivudine significantly reduced HBsAg levels from baseline (mean 3.8 log10 IU/mL) to year 1 (3.3 log10 IU/mL) and year 3 (3.0 log10 IU/mL).

By year 3, 6% of patients experienced HBsAg loss, and 2 of these individuals also experience HBsAg seroconversion.

Patients who lost HBsAg had significantly higher baseline HBsAg levels than patients without HBsAg loss (mean 4.2 vs 3.8 log10IU/mL, respectively).

Participants who lost HBsAg also experienced a greater decline in HBsAg during the first year of treatment (2.1 vs 0.3 log10IU/mL, respectively).

3 distinct patterns of HBsAg kinetics were observed at year 1:

[size=-1] Rapid decline of > 1 log10 IU/mL: 31 patients, 26% of whom had HBsAg loss at year 3;

Slow progressive decline of < 1 log10 IU/mL: 73 patients, 1.4% of whom had HBsAg loss at year 3;

Fluctuating HBsAg levels: 55 patients.

[size=-1] Patients who experienced rapid HBsAg decline during the first year on telbivudine were more likely to later experience HBsAg loss.

At year 3, 68% of patients achieved HBeAg loss and 54% experienced HBeAg seroconversion.

In this comparison, baseline HBsAg levels were similar in both groups (3.8 log10 IU/mL).

However, patients with HBeAg loss at 3 years had a significantly greater average decline in HBsAg levels at year 1 than patients without HBeAg loss.

[size=-1]In this first study of HBsAg kinetics during long-term nucleoside analog therapy, the researchers concluded, "Telbivudine treatment significantly reduces serum HBsAg levels in patients with HBeAg positive chronic hepatitis B."

"Rapid on-treatment HBsAg decline of >1 log10 IU/mL during the first year is highly predictive of future HBsAg clearance," they added.

Hannover Medical School, Hannover, Germany; Novartis Pharma AG, Basel, Switzerlan.
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   HBsAg损失(减少）


k . Wursthorn和同事看着动力学的乙肝表面抗原全球衰退中积极参与者172 HBeAg侦测病毒DNA(< 300拷贝/毫升)后,2年以上telbivudine期间继续服用这种药物研究上述延伸。


HBsAg间隙的终极目标对于慢性乙型肝炎抗病毒治疗的患者,研究人员注意到作为背景色。测量HBsAg将有助于预测时间和概率的有利的结果。在分析中,测定血清HBsAg水平基线,治疗24周的研究,并在原始地球年1、2和3。


结果

在水平下降,血清表面上逐步telbivudine 3年。Telbivudine HBsAg水平显著降低log10基线水平(平均3.8 /毫升)IU 1年(3.3 log10 IU /毫升)和三年级(3.0 log10 IU /毫升)。


由三年级,有6%的患者出现HBsAg损失,最近2个个人经验HBsAg血清转化率也。


患者有显著高于失去HBsAg基线HBsAg含量比例非HBsAg损失(平均4.2 vs / mL,3.8 log10IU分别)。


参加者失去HBsAg也经历了一个更大的下降在第一年的表面处理(2.1 vs / mL,0.3 log10IU分别)。


不同样式的3年观察HBsAg动力学在1:


[尺寸= - 1]快速下降的log10 > 1 / mL:31例IU,26%的人有HBsAg损失在三年级;


缓慢的逐步退化的< 1 log10 IU / mL:73岁的患者,其中有1.4%的损失在三年级HBsAg;


HBsAg等级:55例波动。

[尺寸= - 1]经历了快速下降的患者在一年内表面上更有可能在以后telbivudine经验HBsAg损失。


在三年级,68%的病人达到HBeAg HBeAg血清转化率损失和54%,经验丰富。


在这个对比、基线HBsAg水平两组相似(3.8 log10 IU /毫升)。


然而,患者3年HBeAg损失明显下降更大的平均水平,在1年表面的患者相比无HBeAg损失。

[尺寸= - 1]在这一研究中乙肝病毒具有灭活作用动力学模拟疗法在长期核苷类似物,研究者总结道,“Telbivudine治疗水平显著地降低患者血清HBsAg HBeAg慢性肝炎b”积极


“快速on-treatment > 1 log10 HBsAg衰落IU / mL第一年的是高度的预测未来的HBsAg间隙,"他们补充说。


汉诺威医学院、汉诺威、德国,诺华制药,巴塞尔