ADEFOVIR DIPIVOXIL (ADV) IS EFFECTIVE FOR THE TREATMENT OF PATIENTS WITH LAM-R CHRONIC HEPATITIS B (CHB) IN CIRRHOTIC AND ELDERLY PATIENTS

[Guest guest]

EASL 2005

http://www.hbvadvocate.org/news/reports/EASL_2005/HBV_16.htm#hbv3

ADEFOVIR DIPIVOXIL (ADV) IS EFFECTIVE FOR THE TREATMENT OF PATIENTS WITH

LAM-R CHRONIC HEPATITIS B (CHB) IN CIRRHOTIC AND ELDERLY PATIENTS

F. Zoulim1, P. Marcellin2, J.P. Zarski3, P. Parvaz4, M. Beaugrand5, Y.

Benhamou6, S. Benoliel7, F. Allaert8, A. Trylesinski7, V. Sitruk7

1Hépato-Gastro-Entérologie/Hôpital Hôtel Dieu, Service INSERM U271, Lyon,

France 2Service Hépatologie/Hôpital Beaujon, Clichy, France 3Service

Hépato-Gastro-Entérologie/CHU Grenoble Vercors Michallon, Grenoble, France

4Clinical Virology Laboratory/Lyon-Nord Hospital, Lyon, France 5Service

Hépato-Gastro-Entérologie/Hôpital Verdier, Bondy, France 6Service

Hépato-Gastro-Entérologie/Hôpital Pitié Salpétrière, Paris, France 7Medical

Affairs/Gilead Sciences, Paris, France 8Cenbiotech, Dijon, France,

Background

Adefovir (ADV) was studied in a broad range of CHB (HBeAg positive, pre-core

mutant, wild type and LAM R) with a significant and consistent efficacy and

is indicated for the treatment of chronic hepatitis B (CHB).

Objective

Evaluate efficacy of ADV 10 mg in LAM-resistant CHB patients in 2

subpopulations.

Methods

94 CHB patients with lamivudine-resistant HBV treated with ADV, followed

routinely between June 2001 and 2003, with HBV DNA >100 000 copies/mL ADV

and one of the following criteria: clinical or histological cirrhosis or age

>65 years were retrospectively monitored. Serum HBV DNA was evaluated at a

central laboratory with the VERSANT HBV DNA 3.0 Assay, Bayer, LLQ 357

IUs/mL) (values presented as medians)

Results

At baseline (n=94 pts: 86 cirrhotic and 8 elderly. 19 pts were cirrhotic and

elderly ): 80% of male patients;42% HBe Ag negative; prior LAM treatment

duration 28 months; age 57.5 years; ADV treatment duration 11.2 months

(2.8-25.9); serum HBVDNA 8.15 log10 copies/mL and ALT 2.22 ULN. 3 patients

reported SAE: 2 death (1 with aneurysm rupture and 1 with hepatic carcinoma

and ascitic decompensation) the 3rd pt was co-infected HBV/HCV with

nephrotic syndrome secondary to Alport syndrome, he received ADV 1 tab every

48h.

Conclusion

In cirrhotic and elderly CHB patients failing LAM therapy treated in

clinical practice with ADV was safe and effective. These results are

consistent with the published results from ADV clinical trials

[Guest guest]

EASL 2005

http://www.hbvadvocate.org/news/reports/EASL_2005/HBV_16.htm#hbv3

ADEFOVIR DIPIVOXIL (ADV) IS EFFECTIVE FOR THE TREATMENT OF PATIENTS WITH

LAM-R CHRONIC HEPATITIS B (CHB) IN CIRRHOTIC AND ELDERLY PATIENTS

F. Zoulim1, P. Marcellin2, J.P. Zarski3, P. Parvaz4, M. Beaugrand5, Y.

Benhamou6, S. Benoliel7, F. Allaert8, A. Trylesinski7, V. Sitruk7

1Hépato-Gastro-Entérologie/Hôpital Hôtel Dieu, Service INSERM U271, Lyon,

France 2Service Hépatologie/Hôpital Beaujon, Clichy, France 3Service

Hépato-Gastro-Entérologie/CHU Grenoble Vercors Michallon, Grenoble, France

4Clinical Virology Laboratory/Lyon-Nord Hospital, Lyon, France 5Service

Hépato-Gastro-Entérologie/Hôpital Verdier, Bondy, France 6Service

Hépato-Gastro-Entérologie/Hôpital Pitié Salpétrière, Paris, France 7Medical

Affairs/Gilead Sciences, Paris, France 8Cenbiotech, Dijon, France,

Background

Adefovir (ADV) was studied in a broad range of CHB (HBeAg positive, pre-core

mutant, wild type and LAM R) with a significant and consistent efficacy and

is indicated for the treatment of chronic hepatitis B (CHB).

Objective

Evaluate efficacy of ADV 10 mg in LAM-resistant CHB patients in 2

subpopulations.

Methods

94 CHB patients with lamivudine-resistant HBV treated with ADV, followed

routinely between June 2001 and 2003, with HBV DNA >100 000 copies/mL ADV

and one of the following criteria: clinical or histological cirrhosis or age

>65 years were retrospectively monitored. Serum HBV DNA was evaluated at a

central laboratory with the VERSANT HBV DNA 3.0 Assay, Bayer, LLQ 357

IUs/mL) (values presented as medians)

Results

At baseline (n=94 pts: 86 cirrhotic and 8 elderly. 19 pts were cirrhotic and

elderly ): 80% of male patients;42% HBe Ag negative; prior LAM treatment

duration 28 months; age 57.5 years; ADV treatment duration 11.2 months

(2.8-25.9); serum HBVDNA 8.15 log10 copies/mL and ALT 2.22 ULN. 3 patients

reported SAE: 2 death (1 with aneurysm rupture and 1 with hepatic carcinoma

and ascitic decompensation) the 3rd pt was co-infected HBV/HCV with

nephrotic syndrome secondary to Alport syndrome, he received ADV 1 tab every

48h.

Conclusion

In cirrhotic and elderly CHB patients failing LAM therapy treated in

clinical practice with ADV was safe and effective. These results are

consistent with the published results from ADV clinical trials

[Guest guest]

EASL 2005

http://www.hbvadvocate.org/news/reports/EASL_2005/HBV_16.htm#hbv3

ADEFOVIR DIPIVOXIL (ADV) IS EFFECTIVE FOR THE TREATMENT OF PATIENTS WITH

LAM-R CHRONIC HEPATITIS B (CHB) IN CIRRHOTIC AND ELDERLY PATIENTS

F. Zoulim1, P. Marcellin2, J.P. Zarski3, P. Parvaz4, M. Beaugrand5, Y.

Benhamou6, S. Benoliel7, F. Allaert8, A. Trylesinski7, V. Sitruk7

1Hépato-Gastro-Entérologie/Hôpital Hôtel Dieu, Service INSERM U271, Lyon,

France 2Service Hépatologie/Hôpital Beaujon, Clichy, France 3Service

Hépato-Gastro-Entérologie/CHU Grenoble Vercors Michallon, Grenoble, France

4Clinical Virology Laboratory/Lyon-Nord Hospital, Lyon, France 5Service

Hépato-Gastro-Entérologie/Hôpital Verdier, Bondy, France 6Service

Hépato-Gastro-Entérologie/Hôpital Pitié Salpétrière, Paris, France 7Medical

Affairs/Gilead Sciences, Paris, France 8Cenbiotech, Dijon, France,

Background

Adefovir (ADV) was studied in a broad range of CHB (HBeAg positive, pre-core

mutant, wild type and LAM R) with a significant and consistent efficacy and

is indicated for the treatment of chronic hepatitis B (CHB).

Objective

Evaluate efficacy of ADV 10 mg in LAM-resistant CHB patients in 2

subpopulations.

Methods

94 CHB patients with lamivudine-resistant HBV treated with ADV, followed

routinely between June 2001 and 2003, with HBV DNA >100 000 copies/mL ADV

and one of the following criteria: clinical or histological cirrhosis or age

>65 years were retrospectively monitored. Serum HBV DNA was evaluated at a

central laboratory with the VERSANT HBV DNA 3.0 Assay, Bayer, LLQ 357

IUs/mL) (values presented as medians)

Results

At baseline (n=94 pts: 86 cirrhotic and 8 elderly. 19 pts were cirrhotic and

elderly ): 80% of male patients;42% HBe Ag negative; prior LAM treatment

duration 28 months; age 57.5 years; ADV treatment duration 11.2 months

(2.8-25.9); serum HBVDNA 8.15 log10 copies/mL and ALT 2.22 ULN. 3 patients

reported SAE: 2 death (1 with aneurysm rupture and 1 with hepatic carcinoma

and ascitic decompensation) the 3rd pt was co-infected HBV/HCV with

nephrotic syndrome secondary to Alport syndrome, he received ADV 1 tab every

48h.

Conclusion

In cirrhotic and elderly CHB patients failing LAM therapy treated in

clinical practice with ADV was safe and effective. These results are

consistent with the published results from ADV clinical trials

[Guest guest]

EASL 2005

http://www.hbvadvocate.org/news/reports/EASL_2005/HBV_16.htm#hbv3

ADEFOVIR DIPIVOXIL (ADV) IS EFFECTIVE FOR THE TREATMENT OF PATIENTS WITH

LAM-R CHRONIC HEPATITIS B (CHB) IN CIRRHOTIC AND ELDERLY PATIENTS

F. Zoulim1, P. Marcellin2, J.P. Zarski3, P. Parvaz4, M. Beaugrand5, Y.

Benhamou6, S. Benoliel7, F. Allaert8, A. Trylesinski7, V. Sitruk7

1Hépato-Gastro-Entérologie/Hôpital Hôtel Dieu, Service INSERM U271, Lyon,

France 2Service Hépatologie/Hôpital Beaujon, Clichy, France 3Service

Hépato-Gastro-Entérologie/CHU Grenoble Vercors Michallon, Grenoble, France

4Clinical Virology Laboratory/Lyon-Nord Hospital, Lyon, France 5Service

Hépato-Gastro-Entérologie/Hôpital Verdier, Bondy, France 6Service

Hépato-Gastro-Entérologie/Hôpital Pitié Salpétrière, Paris, France 7Medical

Affairs/Gilead Sciences, Paris, France 8Cenbiotech, Dijon, France,

Background

Adefovir (ADV) was studied in a broad range of CHB (HBeAg positive, pre-core

mutant, wild type and LAM R) with a significant and consistent efficacy and

is indicated for the treatment of chronic hepatitis B (CHB).

Objective

Evaluate efficacy of ADV 10 mg in LAM-resistant CHB patients in 2

subpopulations.

Methods

94 CHB patients with lamivudine-resistant HBV treated with ADV, followed

routinely between June 2001 and 2003, with HBV DNA >100 000 copies/mL ADV

and one of the following criteria: clinical or histological cirrhosis or age

>65 years were retrospectively monitored. Serum HBV DNA was evaluated at a

central laboratory with the VERSANT HBV DNA 3.0 Assay, Bayer, LLQ 357

IUs/mL) (values presented as medians)

Results

At baseline (n=94 pts: 86 cirrhotic and 8 elderly. 19 pts were cirrhotic and

elderly ): 80% of male patients;42% HBe Ag negative; prior LAM treatment

duration 28 months; age 57.5 years; ADV treatment duration 11.2 months

(2.8-25.9); serum HBVDNA 8.15 log10 copies/mL and ALT 2.22 ULN. 3 patients

reported SAE: 2 death (1 with aneurysm rupture and 1 with hepatic carcinoma

and ascitic decompensation) the 3rd pt was co-infected HBV/HCV with

nephrotic syndrome secondary to Alport syndrome, he received ADV 1 tab every

48h.

Conclusion

In cirrhotic and elderly CHB patients failing LAM therapy treated in

clinical practice with ADV was safe and effective. These results are

consistent with the published results from ADV clinical trials