Peginterferon Alfa-2a (Pegasys) Monotherapy Is More Effective Than Lamivudine (Epivir-HBV) Monotherapy for HBeAg-negative Chronic HBV Patients

[Guest guest]

Peginterferon Alfa-2a (Pegasys) Monotherapy Is More Effective Than

Lamivudine (Epivir-HBV) Monotherapy for HBeAg-negative Chronic HBV Patients

Conventional IFN alfa and lamivudine (Epivir-HBV) are

first-line treatments for chronic hepatitis B (CHB). Recent data have shown

that peginterferon alfa-2a (40KD) (PEGASYS) is superior to conventional IFN

alfa in HBeAg-positive CHB (Cooksley et al, J Viral Hepat 2003).

The aim of the current study was to compare PEGASYS with and

without lamivudine to lamivudine alone in the treatment of HBeAg-negative

CHB.

Adults (n=537) with HBeAg-negative CHB received PEGASYS 180

mg once-weekly plus placebo, PEGASYS 180 ?g once-weekly plus lamivudine 100

mg daily, or lamivudine 100 mg daily, for 48 weeks, with 24-weeks follow-up.

Results

Baseline characteristics were comparable in all treatment

groups. At end-of-follow-up (week 72), using the intent-to-treat analysis,

the percentage of patients with normalized ALT or HBV-DNA <20,000 copies/mL

was significantly higher in the PEGASYS plus placebo and PEGASYS plus

lamivudine groups than the lamivudine group (see table).

Histological response (>=2 point reduction in HAI) was

reported in 47% of patients receiving PEGASYS plus placebo, 37% receiving

PEGASYS plus lamivudine, and 39% receiving lamivudine.

HBsAg response (HBsAg loss ± detection of HBsAb at

end-of-follow-up) was reported in 12 patients receiving PEGASYS (±

lamivudine)compared with none receiving lamivudine alone.

Conclusions

Significantly higher sustained response rates were observed

with PEGASYS monotherapy than with lamivudine monotherapy in the treatment

of HBeAg-negative CHB.

The combination of lamivudine and PEGASYS did not improve

end-of-follow-up response rates over PEGASYS monotherapy.

04/21/04

Reference

P Marcellin and others. PEGINTERFERON ALFA-2A (40KD)

(PEGASYS®) MONOTHERAPY IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN THE

TREATMENT OF HBEAG-NEGATIVE CHRONIC HEPATITIS B: 72-WEEK RESULTS FROM A

PHASE III, PARTIALLY DOUBLE-BLIND STUDY OF PEGASYS® ALONE VS PEGASYS® PLUS

LAMIVUDINE. Abstract 95 (oral). 39th EASL. April 14-18, 2004. Berlin,

Germany.

[Guest guest]

Peginterferon Alfa-2a (Pegasys) Monotherapy Is More Effective Than

Lamivudine (Epivir-HBV) Monotherapy for HBeAg-negative Chronic HBV Patients

Conventional IFN alfa and lamivudine (Epivir-HBV) are

first-line treatments for chronic hepatitis B (CHB). Recent data have shown

that peginterferon alfa-2a (40KD) (PEGASYS) is superior to conventional IFN

alfa in HBeAg-positive CHB (Cooksley et al, J Viral Hepat 2003).

The aim of the current study was to compare PEGASYS with and

without lamivudine to lamivudine alone in the treatment of HBeAg-negative

CHB.

Adults (n=537) with HBeAg-negative CHB received PEGASYS 180

mg once-weekly plus placebo, PEGASYS 180 ?g once-weekly plus lamivudine 100

mg daily, or lamivudine 100 mg daily, for 48 weeks, with 24-weeks follow-up.

Results

Baseline characteristics were comparable in all treatment

groups. At end-of-follow-up (week 72), using the intent-to-treat analysis,

the percentage of patients with normalized ALT or HBV-DNA <20,000 copies/mL

was significantly higher in the PEGASYS plus placebo and PEGASYS plus

lamivudine groups than the lamivudine group (see table).

Histological response (>=2 point reduction in HAI) was

reported in 47% of patients receiving PEGASYS plus placebo, 37% receiving

PEGASYS plus lamivudine, and 39% receiving lamivudine.

HBsAg response (HBsAg loss ± detection of HBsAb at

end-of-follow-up) was reported in 12 patients receiving PEGASYS (±

lamivudine)compared with none receiving lamivudine alone.

Conclusions

Significantly higher sustained response rates were observed

with PEGASYS monotherapy than with lamivudine monotherapy in the treatment

of HBeAg-negative CHB.

The combination of lamivudine and PEGASYS did not improve

end-of-follow-up response rates over PEGASYS monotherapy.

04/21/04

Reference

P Marcellin and others. PEGINTERFERON ALFA-2A (40KD)

(PEGASYS®) MONOTHERAPY IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN THE

TREATMENT OF HBEAG-NEGATIVE CHRONIC HEPATITIS B: 72-WEEK RESULTS FROM A

PHASE III, PARTIALLY DOUBLE-BLIND STUDY OF PEGASYS® ALONE VS PEGASYS® PLUS

LAMIVUDINE. Abstract 95 (oral). 39th EASL. April 14-18, 2004. Berlin,

Germany.

[Guest guest]

Peginterferon Alfa-2a (Pegasys) Monotherapy Is More Effective Than

Lamivudine (Epivir-HBV) Monotherapy for HBeAg-negative Chronic HBV Patients

Conventional IFN alfa and lamivudine (Epivir-HBV) are

first-line treatments for chronic hepatitis B (CHB). Recent data have shown

that peginterferon alfa-2a (40KD) (PEGASYS) is superior to conventional IFN

alfa in HBeAg-positive CHB (Cooksley et al, J Viral Hepat 2003).

The aim of the current study was to compare PEGASYS with and

without lamivudine to lamivudine alone in the treatment of HBeAg-negative

CHB.

Adults (n=537) with HBeAg-negative CHB received PEGASYS 180

mg once-weekly plus placebo, PEGASYS 180 ?g once-weekly plus lamivudine 100

mg daily, or lamivudine 100 mg daily, for 48 weeks, with 24-weeks follow-up.

Results

Baseline characteristics were comparable in all treatment

groups. At end-of-follow-up (week 72), using the intent-to-treat analysis,

the percentage of patients with normalized ALT or HBV-DNA <20,000 copies/mL

was significantly higher in the PEGASYS plus placebo and PEGASYS plus

lamivudine groups than the lamivudine group (see table).

Histological response (>=2 point reduction in HAI) was

reported in 47% of patients receiving PEGASYS plus placebo, 37% receiving

PEGASYS plus lamivudine, and 39% receiving lamivudine.

HBsAg response (HBsAg loss ± detection of HBsAb at

end-of-follow-up) was reported in 12 patients receiving PEGASYS (±

lamivudine)compared with none receiving lamivudine alone.

Conclusions

Significantly higher sustained response rates were observed

with PEGASYS monotherapy than with lamivudine monotherapy in the treatment

of HBeAg-negative CHB.

The combination of lamivudine and PEGASYS did not improve

end-of-follow-up response rates over PEGASYS monotherapy.

04/21/04

Reference

P Marcellin and others. PEGINTERFERON ALFA-2A (40KD)

(PEGASYS®) MONOTHERAPY IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN THE

TREATMENT OF HBEAG-NEGATIVE CHRONIC HEPATITIS B: 72-WEEK RESULTS FROM A

PHASE III, PARTIALLY DOUBLE-BLIND STUDY OF PEGASYS® ALONE VS PEGASYS® PLUS

LAMIVUDINE. Abstract 95 (oral). 39th EASL. April 14-18, 2004. Berlin,

Germany.

[Guest guest]

Peginterferon Alfa-2a (Pegasys) Monotherapy Is More Effective Than

Lamivudine (Epivir-HBV) Monotherapy for HBeAg-negative Chronic HBV Patients

Conventional IFN alfa and lamivudine (Epivir-HBV) are

first-line treatments for chronic hepatitis B (CHB). Recent data have shown

that peginterferon alfa-2a (40KD) (PEGASYS) is superior to conventional IFN

alfa in HBeAg-positive CHB (Cooksley et al, J Viral Hepat 2003).

The aim of the current study was to compare PEGASYS with and

without lamivudine to lamivudine alone in the treatment of HBeAg-negative

CHB.

Adults (n=537) with HBeAg-negative CHB received PEGASYS 180

mg once-weekly plus placebo, PEGASYS 180 ?g once-weekly plus lamivudine 100

mg daily, or lamivudine 100 mg daily, for 48 weeks, with 24-weeks follow-up.

Results

Baseline characteristics were comparable in all treatment

groups. At end-of-follow-up (week 72), using the intent-to-treat analysis,

the percentage of patients with normalized ALT or HBV-DNA <20,000 copies/mL

was significantly higher in the PEGASYS plus placebo and PEGASYS plus

lamivudine groups than the lamivudine group (see table).

Histological response (>=2 point reduction in HAI) was

reported in 47% of patients receiving PEGASYS plus placebo, 37% receiving

PEGASYS plus lamivudine, and 39% receiving lamivudine.

HBsAg response (HBsAg loss ± detection of HBsAb at

end-of-follow-up) was reported in 12 patients receiving PEGASYS (±

lamivudine)compared with none receiving lamivudine alone.

Conclusions

Significantly higher sustained response rates were observed

with PEGASYS monotherapy than with lamivudine monotherapy in the treatment

of HBeAg-negative CHB.

The combination of lamivudine and PEGASYS did not improve

end-of-follow-up response rates over PEGASYS monotherapy.

04/21/04

Reference

P Marcellin and others. PEGINTERFERON ALFA-2A (40KD)

(PEGASYS®) MONOTHERAPY IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN THE

TREATMENT OF HBEAG-NEGATIVE CHRONIC HEPATITIS B: 72-WEEK RESULTS FROM A

PHASE III, PARTIALLY DOUBLE-BLIND STUDY OF PEGASYS® ALONE VS PEGASYS® PLUS

LAMIVUDINE. Abstract 95 (oral). 39th EASL. April 14-18, 2004. Berlin,

Germany.