Peginterferon alfa-2a Produces Durable Responses in Asian Patients With HBeAg-Po

[Guest guest]

CCO Official Conference Coverage of the Shanghai-Hong Kong International

Liver Congress 2006

Peginterferon alfa-2a Produces Durable Responses in Asian Patients With

HBeAg-Positive Chronic Hepatitis B

Long-term follow-up analysis of subgroup from randomized, prospective study

Summary of Key Conclusions

After 48 weeks of peginterferon alfa-2a monotherapy, 83% of Asian patients

who had HBeAg seroconversion by 6 months posttreatment maintained

seroconversion at 1 year

Additional 15% of Asian patients who received peginterferon monotherapy

seroconverted late, at 6-12 months posttreatment

Background

Previous study showed 48-week response rate of peginterferon alfa-2a with or

without lamivudine superior to lamivudine alone in HBeAg-positive patients

with chronic hepatitis B[1]

About 30% of patients receiving peginterferon (with or without lamivudine)

achieved HBeAg seroconversion at 6 months posttreatment vs 19% of patients

receiving lamivudine only

Current study evaluated durability of responses to peginterferon alfa-2a

monotherapy in Asian HBeAg-positive patients participating in long-term

follow-up study[2]

Summary of Study Design

Patients in initial prospective study randomized to receive 48 weeks of

Peginterferon alfa-2a 180 µg once weekly, or

Peginterferon alfa-2a 180 µg once weekly plus lamivudine 100 mg/day, or

Lamivudine 100 mg/day

Initial assessment performed at 6 months posttreatment

Long-term follow-up analysis assessed patients at 12 months posttreatment

Evaluated durability of HBeAg seroconversion, defined as HBeAg loss and

anti-HBe positivity

Baseline Characteristics

81% of study centers and 60% of patients in original study participated in

long-term follow-up

150 of 238 Asian patients who received peginterferon alfa-2a monotherapy

participated in long-term follow-up study

39% (n = 58) of these individuals achieved HBeAg seroconversion at 6 months

posttreatment

Main Findings

39% (58/150) of Asian patients had HBeAg seroconversion at 6 months

posttreatment

83% of these patients (n = 48) maintained seroconversion at 12 months

posttreatment

12% of these patients (n = 7) had partial seroconversion at Year 1 follow-up

HBeAg loss only: n = 3

Seroconversion at 9 months posttreatment, but no data at 12 months: n = 2

No data at 12 months: n = 2

5% of these patients (n = 3) did not maintain seroconversion at 12 months

15% of Asian patients (14/92) lacking seroconversion 6 months posttreatment

achieved seroconversion by 12 months

Individuals with higher baseline ALT and lower baseline viral load tended to

have greater likelihood of sustained HBeAg seroconversion

Characteristic

Sustained HBeAg Seroconversion

(n = 48)

Late HBeAg Seroconversion

(n = 14)

No HBeAg Seroconversion

(n = 78)

Male, %

71

71

81

Median age, yrs (range)

32 (18-57)

30 (19-51)

31 (19-55)

Genotype, %

B

27

36

29

C

73

64

69

Baseline median ALT, U/L (range)

118 (26-381)

108 (39-389)

85 (15-1266)

Baseline median HBV DNA, log10 copies/mL (range)

9.4 (7.4-13.2)

9.9 (5.9-12.6)

9.8 (5.3-6.1)

Other Outcomes

Higher HBV DNA levels in individuals with no HBeAg seroconversion at 1 year

vs both early-sustained and late seroconverters

ALT above upper limit of normal for individuals with no seroconversion at 1

year, but not for early or late seroconverters

HBV DNA level at Year 1 Posttreatment, copies/mL

Sustained HBeAg Seroconversion, %

(n = 53)

Late HBeAg Seroconversion, %

(n = 13)

No HBeAg Seroconversion, %

(n = 67)

& #8804; 400

38

23

< 1

401-10,000

31

23

< 1

10,001-100,000

10

31

< 1

>100,000

21

23

99

References

1. Lau GK, Piratvisuth T, Luo KX, et al. Peginterferon alfa-2a, lamivudine,

and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med.

2005;352:2682-2695.

2. Lau GK, Piratvisuth T, Thongsawat S, et al. Durability of response to

peginterferon alfa-2a (40 KD) (PEGASYS®) in Asian patients with

HBeAg-positive chronic hepatitis B: 12 month follow-up data from a large,

randomized study. Program and abstracts of the 2006 Shanghai-Hong Kong

International Liver Congress; March 25-28, 2006; Shanghai, China. Abstract

49.

http://clinicaloptions.com/Hepatitis/Conference%20Coverage/Shanghai%202006/Capsu\

les/49.aspx?Track=Hepatitis+B

_________________________________________________________________

Is your PC infected? Get a FREE online computer virus scan from McAfee®

Security. http://clinic.mcafee.com/clinic/ibuy/campaign.asp?cid=3963

[Guest guest]

CCO Official Conference Coverage of the Shanghai-Hong Kong International

Liver Congress 2006

Peginterferon alfa-2a Produces Durable Responses in Asian Patients With

HBeAg-Positive Chronic Hepatitis B

Long-term follow-up analysis of subgroup from randomized, prospective study

Summary of Key Conclusions

After 48 weeks of peginterferon alfa-2a monotherapy, 83% of Asian patients

who had HBeAg seroconversion by 6 months posttreatment maintained

seroconversion at 1 year

Additional 15% of Asian patients who received peginterferon monotherapy

seroconverted late, at 6-12 months posttreatment

Background

Previous study showed 48-week response rate of peginterferon alfa-2a with or

without lamivudine superior to lamivudine alone in HBeAg-positive patients

with chronic hepatitis B[1]

About 30% of patients receiving peginterferon (with or without lamivudine)

achieved HBeAg seroconversion at 6 months posttreatment vs 19% of patients

receiving lamivudine only

Current study evaluated durability of responses to peginterferon alfa-2a

monotherapy in Asian HBeAg-positive patients participating in long-term

follow-up study[2]

Summary of Study Design

Patients in initial prospective study randomized to receive 48 weeks of

Peginterferon alfa-2a 180 µg once weekly, or

Peginterferon alfa-2a 180 µg once weekly plus lamivudine 100 mg/day, or

Lamivudine 100 mg/day

Initial assessment performed at 6 months posttreatment

Long-term follow-up analysis assessed patients at 12 months posttreatment

Evaluated durability of HBeAg seroconversion, defined as HBeAg loss and

anti-HBe positivity

Baseline Characteristics

81% of study centers and 60% of patients in original study participated in

long-term follow-up

150 of 238 Asian patients who received peginterferon alfa-2a monotherapy

participated in long-term follow-up study

39% (n = 58) of these individuals achieved HBeAg seroconversion at 6 months

posttreatment

Main Findings

39% (58/150) of Asian patients had HBeAg seroconversion at 6 months

posttreatment

83% of these patients (n = 48) maintained seroconversion at 12 months

posttreatment

12% of these patients (n = 7) had partial seroconversion at Year 1 follow-up

HBeAg loss only: n = 3

Seroconversion at 9 months posttreatment, but no data at 12 months: n = 2

No data at 12 months: n = 2

5% of these patients (n = 3) did not maintain seroconversion at 12 months

15% of Asian patients (14/92) lacking seroconversion 6 months posttreatment

achieved seroconversion by 12 months

Individuals with higher baseline ALT and lower baseline viral load tended to

have greater likelihood of sustained HBeAg seroconversion

Characteristic

Sustained HBeAg Seroconversion

(n = 48)

Late HBeAg Seroconversion

(n = 14)

No HBeAg Seroconversion

(n = 78)

Male, %

71

71

81

Median age, yrs (range)

32 (18-57)

30 (19-51)

31 (19-55)

Genotype, %

B

27

36

29

C

73

64

69

Baseline median ALT, U/L (range)

118 (26-381)

108 (39-389)

85 (15-1266)

Baseline median HBV DNA, log10 copies/mL (range)

9.4 (7.4-13.2)

9.9 (5.9-12.6)

9.8 (5.3-6.1)

Other Outcomes

Higher HBV DNA levels in individuals with no HBeAg seroconversion at 1 year

vs both early-sustained and late seroconverters

ALT above upper limit of normal for individuals with no seroconversion at 1

year, but not for early or late seroconverters

HBV DNA level at Year 1 Posttreatment, copies/mL

Sustained HBeAg Seroconversion, %

(n = 53)

Late HBeAg Seroconversion, %

(n = 13)

No HBeAg Seroconversion, %

(n = 67)

& #8804; 400

38

23

< 1

401-10,000

31

23

< 1

10,001-100,000

10

31

< 1

>100,000

21

23

99

References

1. Lau GK, Piratvisuth T, Luo KX, et al. Peginterferon alfa-2a, lamivudine,

and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med.

2005;352:2682-2695.

2. Lau GK, Piratvisuth T, Thongsawat S, et al. Durability of response to

peginterferon alfa-2a (40 KD) (PEGASYS®) in Asian patients with

HBeAg-positive chronic hepatitis B: 12 month follow-up data from a large,

randomized study. Program and abstracts of the 2006 Shanghai-Hong Kong

International Liver Congress; March 25-28, 2006; Shanghai, China. Abstract

49.

http://clinicaloptions.com/Hepatitis/Conference%20Coverage/Shanghai%202006/Capsu\

les/49.aspx?Track=Hepatitis+B

_________________________________________________________________

Is your PC infected? Get a FREE online computer virus scan from McAfee®

Security. http://clinic.mcafee.com/clinic/ibuy/campaign.asp?cid=3963