High Dose Lamivudine in HBV Cirrhotic Patients with Unsatisfactory Respon

StephenW

<http://www.mdlinx.com/gastroenterology/newsl-article.cfm/3741854/ZZ680655367925639220014/?news_id=511&newsdt=092611&subspec_id=144>

High Dose Lamivudine in HBV-Related Cirrhotic Patients with Unsatisfactory
Response After Adefovir Add-On Digestive Diseases and Sciences, 09/26/2011
Clinical Article

Montagnani M et al. – Rescue strategy with high–dose lamivudine
inhibited viral replication leading to undetectability of serum HBVDNA.
This rescue treatment presented a good safety profile, without adverse
events during the study period. Customized increase of nucleos(t)ide
analogues dose in difficult–to–treat patients may be a proficient
approach in challenging clinical setting.

Methods
6 patients with HBV-related liver cirrhosis were prospectively enrolled.
All were HBeAg-negative and presented a suboptimal response or virological
breakthrough after "adefovir add-on" because of development of clinical
breakthrough during Lamivudine treatment. Lamivudine dose was increased to
200 or 300mg, depending on viral load. After 12 months of follow-up,
virological and biochemical response were evaluated.

Results
After 12 months of high-dose lamivudine, all patients (6/6, 100%) achieved
a significant decrease of serum HBV DNA (mean reduction 2,62± 1,15 Log10
UI/ml, P=0.03) and normalized ALT. In three patients (3/6, 50%), HBV DNA
became undetectable within 6 months. No patient developed liver
decompensation and no significant changes occurred in serum creatinine,
serum and urinary electrolytes. No adverse events were registered.
<http://www.springerlink.com/content/j18vxg85x751862l/> Digestive Diseases
and Sciences DOI: 10.1007/s10620-011-1873-x

Original Article
High Dose Lamivudine in HBV-Related Cirrhotic Patients with Unsatisfactory
Response After Adefovir Add-On

Marco Montagnani, Marina Giandinoto, Andrea Lisotti, Silvia Galli,
Francesco Azzaroli, Federica Buonfiglioli, Laura Turco, Rita Aldini and
Giuseppe Mazzella Abstract Background
Before tenofovir approval for chronic hepatitis B therapy, the clinical
management of patients with suboptimal response or virological breakthrough
during combination treatment with lamivudine and adefovir dipivoxil was a
difficult clinical challenge.

Aims
In order to improve virologic response and reduce the risk of
decompensation, we evaluate the efficacy of a high dose of lamivudine on
chronic HBV patients who have previously presented an unsatisfactory
response during treatment with lamivudine 100mg/day and adefovir 10mg/day.

Methods
Six patients with HBV-related liver cirrhosis were prospectively enrolled.
All were HBeAg-negative and presented a suboptimal response or virological
breakthrough after "adefovir add-on" because of development of clinical
breakthrough during Lamivudine treatment. Lamivudine dose was increased to
200 or 300mg, depending on viral load. After 12 months of follow-up,
virological and biochemical response were evaluated.

Results
After 12 months of high-dose lamivudine, all patients (6/6, 100%) achieved
a significant decrease of serum HBV DNA (mean reduction 2,62 ± 1,15 Log10
UI/ml, P = 0.03) and normalized ALT. In three patients (3/6, 50%), HBV DNA
became undetectable within 6 months. No patient developed liver
decompensation and no significant changes occurred in serum creatinine,
serum and urinary electrolytes. No adverse events were registered.

Conclusions
In our experience, rescue strategy with high-dose lamivudine inhibited
viral replication leading to undetectability of serum HBVDNA. This rescue
treatment presented a good safety profile, without adverse events during
the study period. Customized increase of nucleos(t)ide analogues dose in
difficult-to-treat patients may be a proficient approach in challenging
clinical setting.



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StephenW

[谷歌翻译
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高剂量拉米夫定在HBV相关的肝硬化患者，不合格
响应后，阿德福韦附加消化系统疾病与科学，2011年9月26日
临床条

Montagnani M等。 - 与高剂量的拉米夫定救援策略
导致不可检测血清HBVDNA的抑制病毒复制。
这个抢救治疗提出了一个良好的安全性，无不良
在研究期间事件。核苷（酸）IDE定制增加
类似物难以治疗的患者剂量可精通
在富有挑战性的临床方法。

方法
6 HBV相关的肝硬化患者进行前瞻性登记。
所有HBeAg阴性，并提出一个次优的反应或病毒学
突破后，“阿德福韦附加”，因为临床开发
在拉米夫定治疗的突破。拉米夫定剂量增加
200或300 mg，根据病毒载量。经过12个月的随访，
病毒学和生物化学反应进行了评估。

结果
经过12个月的高剂量拉米夫定，所有患者（6 / 6，100％）实现
血清HBV DNA的一个显著减少（平均减少2,62 ± 1,15 LOG10
UI /毫升，p = 0.03）和ALT复常。 3例（3 / 6，50％），HBV - DNA
成为检测不到6个月内。没有病人肝开发
失代偿期和发生在血清肌酐无显着性变化，
血清和尿电解质。无不良事件进行了注册。
<http://www.springerlink.com/content/j18vxg85x751862l/&gt;消化系统疾病
与科学DOI：10.1007/s10620-011-1873-x

原创文章
高剂量拉米夫定在HBV相关的肝硬化患者，不合格
阿德福韦响应后附加

马哥Montagnani，滨海Giandinoto，安德烈Lisotti，西尔维娅嘉丽，
弗朗切斯科Azzaroli，Federica Buonfiglioli，劳拉图尔科，丽塔Aldini
朱塞佩Mazzella摘要背景
泰诺福韦批准用于慢性乙型肝炎的治疗，临床前
不理想的反应或病毒学突破患者的管理
在结合治疗拉米夫定和阿德福韦酯是一种
困难的临床挑战。

目标
为了提高病毒学应答和减少风险。
失代偿期，我们评估高剂量的拉米夫定的疗效
慢性乙型肝炎先前已提出了一个不理想的患者
治疗期间，拉米夫定100mg/day和阿德福韦10mg/day的响应。

方法
6 HBV相关的肝硬化患者进行前瞻性登记。
所有HBeAg阴性，并提出一个次优的反应或病毒学
突破后，“阿德福韦附加”，因为临床开发
在拉米夫定治疗的突破。拉米夫定剂量增加
200或300 mg，根据病毒载量。经过12个月的随访，
病毒学和生物化学反应进行了评估。

结果
经过12个月的高剂量拉米夫定，所有患者（6 / 6，100％）实现
血清HBV DNA的一个显著减少（平均减少2,62 ± 1,15 LOG10
UI /毫升，p = 0.03）和ALT复常。 3例（3 / 6，50％），HBV - DNA
成为检测不到6个月内。没有病人肝开发
失代偿期和发生在血清肌酐无显着性变化，
血清和尿电解质。无不良事件进行了注册。

结论
根据我们的经验，救援策略与高剂量的拉米夫定抑制
病毒复制导致不可检测血清HBVDNA的。这救援
治疗提出了一个良好的安全性，无不良事件在
在研究期间。核苷（酸）IDE类似物剂量定制增加
在富有挑战性的，难以治疗的患者可能是一名熟练的方法
临床设置。