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

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http://www.mdlinx.com/gastroenterology/newsl-article.cfm/3741854/ZZ6806553679256\

39220014/?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, Lisotti, Silvia Galli, Francesco

Azzaroli, Federica Buonfiglioli, 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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http://www.mdlinx.com/gastroenterology/newsl-article.cfm/3741854/ZZ6806553679256\

39220014/?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, Lisotti, Silvia Galli, Francesco

Azzaroli, Federica Buonfiglioli, 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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