Peginterferon Alfa-2b (PEG-Intron) Monotherapy and in Combination with Lamivudine Improves Liver Histology in Chronic HBV Patients but Does Not Significantly Improve Fibrosis

[Guest guest]

Peginterferon Alfa-2b (PEG-Intron) Monotherapy and in Combination with

Lamivudine Improves Liver Histology in Chronic HBV Patients but Does Not

Significantly Improve Fibrosis

The two established therapies for chronic hepatitis B (CHB), interferon and

lamivudine, have been shown to improve liver histology. Dutch researchers

studied the effect of pegylated interferon alfa-2b (PEG-IFN) therapy alone

and

in combination with lamivudine on liver histology.

A total of 266 HBeAg-positive CHB patients were treated for 52 weeks with

PEG-IFN 100 mg/week in combination with either lamivudine 100 mg/day or

placebo in a double-blinded, randomized, multi-center study.

PEG-IFN dose was halved after 32 weeks of treatment.

Liver biopsies were requested before treatment and at the end of treatment

(optional). All biopsies were blinded and scored according to the Ishak

system

which includes a necroinflammatory score (0-18) and a fibrosis score (0-6).

Paired and evaluable biopsies were available for 110 patients.

The mean baseline scores of the two treatment groups were comparable.

Overall, inflammation score improved (mean score 5.5 pretreatment vs 3.9

post-treatment, p<0.001) and there was a slight progression in fibrosis

(mean

score 2.4 pretreatment vs 2.7 post-treatment, p=0.03).

Necroinflammatory score improved in 25 patients (48%) in the combination

group

and in 31 patients (53%) in the PEG-IFN monotherapy group.

Fibrosis score improved more often in the combination group (17 patients

(33%)

versus 13 patients (22%) respectively (p=0.23)).

In responders (n=48), defined as HBeAg negative at the end of follow-up,

inflammation score improved in 65%, compared to 38% of non-responders

(n=0.06).

In conclusion, PEG-IFN therapy improves liver histology in CHB patients. We

found an improvement in necroinflammatory scores but no significant

reduction

of fibrosis in both treatment groups.

Gastroenterology and Hepatology, Erasmus Mc, Rotterdam, The Netherlands

Pathology, Erasmus Mc, Rotterdam, The Netherlands.

04/21/04

Reference

M van Zonneveld and others. LIVER HISTOLOGY IN CHRONIC HEPATITIS B PATIENTS

AFTER 1 YEAR OF TREATMENT WITH PEGYLATED INTERFERON ALPHA-2B IN COMBINATION

WITH LAMIVUDINE OR PLACEBO. Abstract 447. 39th EASL. April 14-18, 2004.

Berlin, Germany.

[Guest guest]

Peginterferon Alfa-2b (PEG-Intron) Monotherapy and in Combination with

Lamivudine Improves Liver Histology in Chronic HBV Patients but Does Not

Significantly Improve Fibrosis

The two established therapies for chronic hepatitis B (CHB), interferon and

lamivudine, have been shown to improve liver histology. Dutch researchers

studied the effect of pegylated interferon alfa-2b (PEG-IFN) therapy alone

and

in combination with lamivudine on liver histology.

A total of 266 HBeAg-positive CHB patients were treated for 52 weeks with

PEG-IFN 100 mg/week in combination with either lamivudine 100 mg/day or

placebo in a double-blinded, randomized, multi-center study.

PEG-IFN dose was halved after 32 weeks of treatment.

Liver biopsies were requested before treatment and at the end of treatment

(optional). All biopsies were blinded and scored according to the Ishak

system

which includes a necroinflammatory score (0-18) and a fibrosis score (0-6).

Paired and evaluable biopsies were available for 110 patients.

The mean baseline scores of the two treatment groups were comparable.

Overall, inflammation score improved (mean score 5.5 pretreatment vs 3.9

post-treatment, p<0.001) and there was a slight progression in fibrosis

(mean

score 2.4 pretreatment vs 2.7 post-treatment, p=0.03).

Necroinflammatory score improved in 25 patients (48%) in the combination

group

and in 31 patients (53%) in the PEG-IFN monotherapy group.

Fibrosis score improved more often in the combination group (17 patients

(33%)

versus 13 patients (22%) respectively (p=0.23)).

In responders (n=48), defined as HBeAg negative at the end of follow-up,

inflammation score improved in 65%, compared to 38% of non-responders

(n=0.06).

In conclusion, PEG-IFN therapy improves liver histology in CHB patients. We

found an improvement in necroinflammatory scores but no significant

reduction

of fibrosis in both treatment groups.

Gastroenterology and Hepatology, Erasmus Mc, Rotterdam, The Netherlands

Pathology, Erasmus Mc, Rotterdam, The Netherlands.

04/21/04

Reference

M van Zonneveld and others. LIVER HISTOLOGY IN CHRONIC HEPATITIS B PATIENTS

AFTER 1 YEAR OF TREATMENT WITH PEGYLATED INTERFERON ALPHA-2B IN COMBINATION

WITH LAMIVUDINE OR PLACEBO. Abstract 447. 39th EASL. April 14-18, 2004.

Berlin, Germany.

[Guest guest]

Peginterferon Alfa-2b (PEG-Intron) Monotherapy and in Combination with

Lamivudine Improves Liver Histology in Chronic HBV Patients but Does Not

Significantly Improve Fibrosis

The two established therapies for chronic hepatitis B (CHB), interferon and

lamivudine, have been shown to improve liver histology. Dutch researchers

studied the effect of pegylated interferon alfa-2b (PEG-IFN) therapy alone

and

in combination with lamivudine on liver histology.

A total of 266 HBeAg-positive CHB patients were treated for 52 weeks with

PEG-IFN 100 mg/week in combination with either lamivudine 100 mg/day or

placebo in a double-blinded, randomized, multi-center study.

PEG-IFN dose was halved after 32 weeks of treatment.

Liver biopsies were requested before treatment and at the end of treatment

(optional). All biopsies were blinded and scored according to the Ishak

system

which includes a necroinflammatory score (0-18) and a fibrosis score (0-6).

Paired and evaluable biopsies were available for 110 patients.

The mean baseline scores of the two treatment groups were comparable.

Overall, inflammation score improved (mean score 5.5 pretreatment vs 3.9

post-treatment, p<0.001) and there was a slight progression in fibrosis

(mean

score 2.4 pretreatment vs 2.7 post-treatment, p=0.03).

Necroinflammatory score improved in 25 patients (48%) in the combination

group

and in 31 patients (53%) in the PEG-IFN monotherapy group.

Fibrosis score improved more often in the combination group (17 patients

(33%)

versus 13 patients (22%) respectively (p=0.23)).

In responders (n=48), defined as HBeAg negative at the end of follow-up,

inflammation score improved in 65%, compared to 38% of non-responders

(n=0.06).

In conclusion, PEG-IFN therapy improves liver histology in CHB patients. We

found an improvement in necroinflammatory scores but no significant

reduction

of fibrosis in both treatment groups.

Gastroenterology and Hepatology, Erasmus Mc, Rotterdam, The Netherlands

Pathology, Erasmus Mc, Rotterdam, The Netherlands.

04/21/04

Reference

M van Zonneveld and others. LIVER HISTOLOGY IN CHRONIC HEPATITIS B PATIENTS

AFTER 1 YEAR OF TREATMENT WITH PEGYLATED INTERFERON ALPHA-2B IN COMBINATION

WITH LAMIVUDINE OR PLACEBO. Abstract 447. 39th EASL. April 14-18, 2004.

Berlin, Germany.

[Guest guest]

Peginterferon Alfa-2b (PEG-Intron) Monotherapy and in Combination with

Lamivudine Improves Liver Histology in Chronic HBV Patients but Does Not

Significantly Improve Fibrosis

The two established therapies for chronic hepatitis B (CHB), interferon and

lamivudine, have been shown to improve liver histology. Dutch researchers

studied the effect of pegylated interferon alfa-2b (PEG-IFN) therapy alone

and

in combination with lamivudine on liver histology.

A total of 266 HBeAg-positive CHB patients were treated for 52 weeks with

PEG-IFN 100 mg/week in combination with either lamivudine 100 mg/day or

placebo in a double-blinded, randomized, multi-center study.

PEG-IFN dose was halved after 32 weeks of treatment.

Liver biopsies were requested before treatment and at the end of treatment

(optional). All biopsies were blinded and scored according to the Ishak

system

which includes a necroinflammatory score (0-18) and a fibrosis score (0-6).

Paired and evaluable biopsies were available for 110 patients.

The mean baseline scores of the two treatment groups were comparable.

Overall, inflammation score improved (mean score 5.5 pretreatment vs 3.9

post-treatment, p<0.001) and there was a slight progression in fibrosis

(mean

score 2.4 pretreatment vs 2.7 post-treatment, p=0.03).

Necroinflammatory score improved in 25 patients (48%) in the combination

group

and in 31 patients (53%) in the PEG-IFN monotherapy group.

Fibrosis score improved more often in the combination group (17 patients

(33%)

versus 13 patients (22%) respectively (p=0.23)).

In responders (n=48), defined as HBeAg negative at the end of follow-up,

inflammation score improved in 65%, compared to 38% of non-responders

(n=0.06).

In conclusion, PEG-IFN therapy improves liver histology in CHB patients. We

found an improvement in necroinflammatory scores but no significant

reduction

of fibrosis in both treatment groups.

Gastroenterology and Hepatology, Erasmus Mc, Rotterdam, The Netherlands

Pathology, Erasmus Mc, Rotterdam, The Netherlands.

04/21/04

Reference

M van Zonneveld and others. LIVER HISTOLOGY IN CHRONIC HEPATITIS B PATIENTS

AFTER 1 YEAR OF TREATMENT WITH PEGYLATED INTERFERON ALPHA-2B IN COMBINATION

WITH LAMIVUDINE OR PLACEBO. Abstract 447. 39th EASL. April 14-18, 2004.

Berlin, Germany.