Significant Reduction of HBsAg in the Sera of HBeAg-Negative Chronic Hepatitis

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AASLD 2006

#970. Significant Reduction of HBsAg in the Sera of HBeAg-Negative Chronic

Hepatitis B Patients Treated with Peginterferon Alfa-2a Alone or in

Combination with Lamivudine

M. Brunetto; F. Bonino; F. Moriconi; M. ; L. K. ; F. Patrizia;

C. Yurdaydin; T. Piratvisuth; K. Luo; Y. Wang; S. Hadziyannis; E. Wolf; P.

Matei

Background:

The ultimate goal of therapy in chronic HBV infection is the achievement of

hepatitis B surface antigen (HBsAg) seroconversion, an entical state to that

achieved effectively after self-limited acute infection and leading to

prolonged survival. In a recent multinational trial, loss of HBsAg was

reported in patients treated with peginterferon alfa-2a (40KD) alone or in

combination with lamivudine (LAM), but not with LAM monotherapy.

Objectives:

To quantify the reduction of HBsAg upon treatment with peginterferon alfa-2a

alone, ± LAM or LAM alone.

Methods:

We measured serum HBsAg pre-treatment, at the end of treatment (week 48) and

24 weeks post-treatment (week 72), using the Architect HBsAg assay (Abbott

Lab) in a subset (386 of 537) of HBeAg-negative patients treated with 180mcg

peginterferon alfa-2a once-weekly (qw) plus placebo daily (n=127), 180mcg

peginterferon alfa-2a + 100mg LAM qd (n=137), or 100mg LAM qd (n=122).

Results:

In peginterferon alfa-2a groups 10 (4%) patients lost HBsAg at 72 weeks – 6

monotherapy and 4 combination therapy. Mean baseline HBsAg level was 3.4 log

IU/ml without difference among treatment groups (table). In peginterferon

alfa-2a patients ± LAM HBsAg reductions were significant during treatment

and follow-up (p < 0.001) whereas no significant reductions were observed in

LAM patients (table). HBsAg reductions were most profound in genotype A

patients, intermediate in genotype B and C and least in genotype D patients.

Among peginterferon alfa-2a monotherapy patients mean HBsAg reductions at

the end of treatment were 1.16, 0.75 and 0.38 log IU/mL for genotype A

(n=8), B/C (n=97) and D (n=17), respectively. The corresponding reductions

24 weeks post-treatment were 1.05, 0.60 and 0.36 log IU/mL.

Conclusions:

Peginterferon alfa-2a ± LAM proves a significant HBsAg reduction in the sera

of HBeAg-negative chronic hepatitis B patients. In contrast, no significant

HBsAg reduction was observed during LAM monotherapy. The degree of HBsAg

reduction seems to be HBV genotype-dependent.

HBsAntigen (log IU/ml

PEG-IFN

(n=127)

PEG-IFN+

LAM

(n=137)

LAM

(n=122)

Pre-trmt†

3.32±0.61

3.46±0.58

3.43±0.57

Reduction vs pre-trmt†

Week 48

Week 72

0.71±1.28*

0.59±1.20*

0.67±1.17*

0.51±1.03*

0.02±0.42

0.06±0.46

Pts with reduced HBsAg (week 72 vs. pre-trmt)

>= 2.0 log

>= 1.0 log

>= 0.5 log

10/127(8%) §

19/127(15%)#

50/127(39%)§

11/137(8%) §

24/137(18%)§

39/137(28%)§

0

6/122(5%)

12/122 (10%)

†mean ± SD *p<0.01 (vs. baseline); §p<0.01 (vs. lamivudine); #p=0.01 (vs.

lamivudine)

_________________________________________________________________

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AASLD 2006

#970. Significant Reduction of HBsAg in the Sera of HBeAg-Negative Chronic

Hepatitis B Patients Treated with Peginterferon Alfa-2a Alone or in

Combination with Lamivudine

M. Brunetto; F. Bonino; F. Moriconi; M. ; L. K. ; F. Patrizia;

C. Yurdaydin; T. Piratvisuth; K. Luo; Y. Wang; S. Hadziyannis; E. Wolf; P.

Matei

Background:

The ultimate goal of therapy in chronic HBV infection is the achievement of

hepatitis B surface antigen (HBsAg) seroconversion, an entical state to that

achieved effectively after self-limited acute infection and leading to

prolonged survival. In a recent multinational trial, loss of HBsAg was

reported in patients treated with peginterferon alfa-2a (40KD) alone or in

combination with lamivudine (LAM), but not with LAM monotherapy.

Objectives:

To quantify the reduction of HBsAg upon treatment with peginterferon alfa-2a

alone, ± LAM or LAM alone.

Methods:

We measured serum HBsAg pre-treatment, at the end of treatment (week 48) and

24 weeks post-treatment (week 72), using the Architect HBsAg assay (Abbott

Lab) in a subset (386 of 537) of HBeAg-negative patients treated with 180mcg

peginterferon alfa-2a once-weekly (qw) plus placebo daily (n=127), 180mcg

peginterferon alfa-2a + 100mg LAM qd (n=137), or 100mg LAM qd (n=122).

Results:

In peginterferon alfa-2a groups 10 (4%) patients lost HBsAg at 72 weeks – 6

monotherapy and 4 combination therapy. Mean baseline HBsAg level was 3.4 log

IU/ml without difference among treatment groups (table). In peginterferon

alfa-2a patients ± LAM HBsAg reductions were significant during treatment

and follow-up (p < 0.001) whereas no significant reductions were observed in

LAM patients (table). HBsAg reductions were most profound in genotype A

patients, intermediate in genotype B and C and least in genotype D patients.

Among peginterferon alfa-2a monotherapy patients mean HBsAg reductions at

the end of treatment were 1.16, 0.75 and 0.38 log IU/mL for genotype A

(n=8), B/C (n=97) and D (n=17), respectively. The corresponding reductions

24 weeks post-treatment were 1.05, 0.60 and 0.36 log IU/mL.

Conclusions:

Peginterferon alfa-2a ± LAM proves a significant HBsAg reduction in the sera

of HBeAg-negative chronic hepatitis B patients. In contrast, no significant

HBsAg reduction was observed during LAM monotherapy. The degree of HBsAg

reduction seems to be HBV genotype-dependent.

HBsAntigen (log IU/ml

PEG-IFN

(n=127)

PEG-IFN+

LAM

(n=137)

LAM

(n=122)

Pre-trmt†

3.32±0.61

3.46±0.58

3.43±0.57

Reduction vs pre-trmt†

Week 48

Week 72

0.71±1.28*

0.59±1.20*

0.67±1.17*

0.51±1.03*

0.02±0.42

0.06±0.46

Pts with reduced HBsAg (week 72 vs. pre-trmt)

>= 2.0 log

>= 1.0 log

>= 0.5 log

10/127(8%) §

19/127(15%)#

50/127(39%)§

11/137(8%) §

24/137(18%)§

39/137(28%)§

0

6/122(5%)

12/122 (10%)

†mean ± SD *p<0.01 (vs. baseline); §p<0.01 (vs. lamivudine); #p=0.01 (vs.

lamivudine)

_________________________________________________________________

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AASLD 2006

#970. Significant Reduction of HBsAg in the Sera of HBeAg-Negative Chronic

Hepatitis B Patients Treated with Peginterferon Alfa-2a Alone or in

Combination with Lamivudine

M. Brunetto; F. Bonino; F. Moriconi; M. ; L. K. ; F. Patrizia;

C. Yurdaydin; T. Piratvisuth; K. Luo; Y. Wang; S. Hadziyannis; E. Wolf; P.

Matei

Background:

The ultimate goal of therapy in chronic HBV infection is the achievement of

hepatitis B surface antigen (HBsAg) seroconversion, an entical state to that

achieved effectively after self-limited acute infection and leading to

prolonged survival. In a recent multinational trial, loss of HBsAg was

reported in patients treated with peginterferon alfa-2a (40KD) alone or in

combination with lamivudine (LAM), but not with LAM monotherapy.

Objectives:

To quantify the reduction of HBsAg upon treatment with peginterferon alfa-2a

alone, ± LAM or LAM alone.

Methods:

We measured serum HBsAg pre-treatment, at the end of treatment (week 48) and

24 weeks post-treatment (week 72), using the Architect HBsAg assay (Abbott

Lab) in a subset (386 of 537) of HBeAg-negative patients treated with 180mcg

peginterferon alfa-2a once-weekly (qw) plus placebo daily (n=127), 180mcg

peginterferon alfa-2a + 100mg LAM qd (n=137), or 100mg LAM qd (n=122).

Results:

In peginterferon alfa-2a groups 10 (4%) patients lost HBsAg at 72 weeks – 6

monotherapy and 4 combination therapy. Mean baseline HBsAg level was 3.4 log

IU/ml without difference among treatment groups (table). In peginterferon

alfa-2a patients ± LAM HBsAg reductions were significant during treatment

and follow-up (p < 0.001) whereas no significant reductions were observed in

LAM patients (table). HBsAg reductions were most profound in genotype A

patients, intermediate in genotype B and C and least in genotype D patients.

Among peginterferon alfa-2a monotherapy patients mean HBsAg reductions at

the end of treatment were 1.16, 0.75 and 0.38 log IU/mL for genotype A

(n=8), B/C (n=97) and D (n=17), respectively. The corresponding reductions

24 weeks post-treatment were 1.05, 0.60 and 0.36 log IU/mL.

Conclusions:

Peginterferon alfa-2a ± LAM proves a significant HBsAg reduction in the sera

of HBeAg-negative chronic hepatitis B patients. In contrast, no significant

HBsAg reduction was observed during LAM monotherapy. The degree of HBsAg

reduction seems to be HBV genotype-dependent.

HBsAntigen (log IU/ml

PEG-IFN

(n=127)

PEG-IFN+

LAM

(n=137)

LAM

(n=122)

Pre-trmt†

3.32±0.61

3.46±0.58

3.43±0.57

Reduction vs pre-trmt†

Week 48

Week 72

0.71±1.28*

0.59±1.20*

0.67±1.17*

0.51±1.03*

0.02±0.42

0.06±0.46

Pts with reduced HBsAg (week 72 vs. pre-trmt)

>= 2.0 log

>= 1.0 log

>= 0.5 log

10/127(8%) §

19/127(15%)#

50/127(39%)§

11/137(8%) §

24/137(18%)§

39/137(28%)§

0

6/122(5%)

12/122 (10%)

†mean ± SD *p<0.01 (vs. baseline); §p<0.01 (vs. lamivudine); #p=0.01 (vs.

lamivudine)

_________________________________________________________________

Use your PC to make calls at very low rates

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[Guest guest]

www.hbvadvocate.org

AASLD 2006

#970. Significant Reduction of HBsAg in the Sera of HBeAg-Negative Chronic

Hepatitis B Patients Treated with Peginterferon Alfa-2a Alone or in

Combination with Lamivudine

M. Brunetto; F. Bonino; F. Moriconi; M. ; L. K. ; F. Patrizia;

C. Yurdaydin; T. Piratvisuth; K. Luo; Y. Wang; S. Hadziyannis; E. Wolf; P.

Matei

Background:

The ultimate goal of therapy in chronic HBV infection is the achievement of

hepatitis B surface antigen (HBsAg) seroconversion, an entical state to that

achieved effectively after self-limited acute infection and leading to

prolonged survival. In a recent multinational trial, loss of HBsAg was

reported in patients treated with peginterferon alfa-2a (40KD) alone or in

combination with lamivudine (LAM), but not with LAM monotherapy.

Objectives:

To quantify the reduction of HBsAg upon treatment with peginterferon alfa-2a

alone, ± LAM or LAM alone.

Methods:

We measured serum HBsAg pre-treatment, at the end of treatment (week 48) and

24 weeks post-treatment (week 72), using the Architect HBsAg assay (Abbott

Lab) in a subset (386 of 537) of HBeAg-negative patients treated with 180mcg

peginterferon alfa-2a once-weekly (qw) plus placebo daily (n=127), 180mcg

peginterferon alfa-2a + 100mg LAM qd (n=137), or 100mg LAM qd (n=122).

Results:

In peginterferon alfa-2a groups 10 (4%) patients lost HBsAg at 72 weeks – 6

monotherapy and 4 combination therapy. Mean baseline HBsAg level was 3.4 log

IU/ml without difference among treatment groups (table). In peginterferon

alfa-2a patients ± LAM HBsAg reductions were significant during treatment

and follow-up (p < 0.001) whereas no significant reductions were observed in

LAM patients (table). HBsAg reductions were most profound in genotype A

patients, intermediate in genotype B and C and least in genotype D patients.

Among peginterferon alfa-2a monotherapy patients mean HBsAg reductions at

the end of treatment were 1.16, 0.75 and 0.38 log IU/mL for genotype A

(n=8), B/C (n=97) and D (n=17), respectively. The corresponding reductions

24 weeks post-treatment were 1.05, 0.60 and 0.36 log IU/mL.

Conclusions:

Peginterferon alfa-2a ± LAM proves a significant HBsAg reduction in the sera

of HBeAg-negative chronic hepatitis B patients. In contrast, no significant

HBsAg reduction was observed during LAM monotherapy. The degree of HBsAg

reduction seems to be HBV genotype-dependent.

HBsAntigen (log IU/ml

PEG-IFN

(n=127)

PEG-IFN+

LAM

(n=137)

LAM

(n=122)

Pre-trmt†

3.32±0.61

3.46±0.58

3.43±0.57

Reduction vs pre-trmt†

Week 48

Week 72

0.71±1.28*

0.59±1.20*

0.67±1.17*

0.51±1.03*

0.02±0.42

0.06±0.46

Pts with reduced HBsAg (week 72 vs. pre-trmt)

>= 2.0 log

>= 1.0 log

>= 0.5 log

10/127(8%) §

19/127(15%)#

50/127(39%)§

11/137(8%) §

24/137(18%)§

39/137(28%)§

0

6/122(5%)

12/122 (10%)

†mean ± SD *p<0.01 (vs. baseline); §p<0.01 (vs. lamivudine); #p=0.01 (vs.

lamivudine)

_________________________________________________________________

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