Pegasys和Peg Alfa-2a+lam和lam单独治疗E抗原阳性者疗效(2005.4.20)

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Peginterferon Alfa-2a (Pegasys) Versus Peginterferon Alfa-2a Plus Lamivudine Versus Lamivudine Alone In HBeAg Positive Chronic HBV In chronic hepatitis C, previous treatment and extent of drug exposure seem to have an impact on response rates. In patients with chronic hepatitis B (CHB) the effects of previous anti-HBV treatment and exposure to study drug on responses to pegylated interferon have not been well studied.

The purpose of the current study was to investigate the effect of previous treatment and drug exposure on efficacy and safety in a randomised, partially double-blind, multinational study.

HBeAg-positive patients (n=814) received (1:1:1) either peginterferon alfa-2a [Pegasys] (180μg once-weekly) + placebo, peginterferon alfa-2a + lamivudine (100mg once-daily) or lamivudine monotherapy.

Patients were treated for 48 weeks and assessed 24 weeks after the end of treatment (week 72). Treatment with any anti-HBV drug 6 months before study entry was not permitted. Analysis of drug exposure was performed only in the peginterferon alfa-2a monotherapy arm.

Results

· The effects of previous treatment with either interferon and/or lamivudine on HBeAg seroconversion rates are shown in the table below.

· Regardless of whether patients were pre-treated or not, HBeAg seroconversion rates at week 72 were higher with peginterferon alfa-2a and combination therapy than with lamivudine.

· The rate of adherence to peginterferon alfa-2a was high, with 78% of patients receiving >=90% of the total drug dosage (>=7776μg).

· HBeAg seroconversion rates were 28% in those receiving <90% of the total drug dosage and 33% in those receiving >=90% of the total drug dosage.

Conclusions

Based on these results, the authors conclude, “Peginterferon alfa-2a…provided higher rates of HBeAg seroconversion than lamivudine, irrespective of whether the patients had or had not received previous anti-HBV therapy.”

“Previous treatment with interferon or lamivudine did not substantially affect HBeAg seroconversion rates with peginterferon alfa-2a in this study. Adherence to peginterferon alfa-2a in this study was excellent.”

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1Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China 2Department of Medicine, Songklanakarin Hospital, Songkla, Thailand 3Department of Infectious Diseases, Nangfang Hospital, Guangzhou, China 4Service D’Hépatologie, INSERM Unite 481 and Centre De Recherches Claude Bernard Sur Les Hépatites Virales, Hôpital Beaujon, Clichy, France 5Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand 6Gastroenterology Department, Middlemore Hospital, Otahuhu, New Zealand 7University of North Carolina Liver Program, University of North Carolina, Chapel Hill NC, USA 8Clinical Research Department, Royal Brisbane Hospital, Brisbane, Australia 9Roche, Dee Why, Australia 10Chang Gung Memorial Hospital, Linkou, Taiwan.

04/18/05

Reference G K K Lau and others. PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) VERSUS PEGINTERFERON ALFA-2A PLUS LAMIVUDINE VERSUS LAMIVUDINE IN HBEAG-POSITIVE CHRONIC HBV: EFFECT OF PREVIOUS TREATMENT AND DRUG EXPOSURE ON SUSTAINED RESPONSE. Abstract 31 (oral). 40th EASL. April 13-17, 2005. Paris, France.