Pegasys治疗HBV后S抗原持续阴转的患者(2005.4.20 EASL)

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Sustained HBsAg Seroconversion in Patients with Chronic HBV Treated with Peginterferon Alfa 2a (Pegasys)

HBsAg seroconversion (loss of HBsAg and appearance of anti-HBs) is considered to be the ultimate goal of anti-HBV treatment. It is, however, a rare event occurring in a negligible number of patients treated with nucleos(t)ide analogues, mostly in patients with HBV genotype A and after >1 year of continuous therapy.

The objectives of this study were to describe HBsAg responses in 1351 patients with HBeAg-positive or -negative CHB who were enrolled in two randomised, partially double-blind, multinational studies comparing peginterferon alfa-2a (Pegasys) monotherapy, peginterferon alfa-2a plus lamivudine (Epivir-HBV), and lamivudine alone.

HBeAg-positive (n=814) and -negative (n=537) patients received (1:1:1) either peginterferon alfa-2a (180μg once-weekly) + placebo, peginterferon alfa-2a + lamivudine (100mg once-daily) or lamivudine.

Patients were treated for 48 weeks and assessed 24 weeks after the end of treatment (week 72). Patients were considered to have sustained HBsAg seroconversion only if they were HBsAg-negative/anti-HBs-positive at week 72.

Results

· Over 75% of patients in the studies were of Asian origin; predominant HBV genotypes in the study populations were B (27%) and C (50%).

· Overall HBsAg seroconversion rates at week 72, and rates stratified by ethnicity and genotype are shown in the Table.

· HBsAg seroconversion only occurred in patients achieving HBeAg seroconversion - among responders with HBeAg seroconversion, the rate of HBsAg seroconversion was 10% with peginterferon alfa-2a-containing therapy and 0% with lamivudine.

Conclusions

The authors conclude, “In our study, patients treated with a peginterferon alfa-2a-containing regimen for a defined duration achieved sustained HBsAg seroconversion, while patients treated with lamivudine did not.”

“The magnitude of HBV-DNA suppression on treatment does not seem to be the major factor leading to HBsAg response, but rather the additional immunomodulatory effect associated with peginterferon alfa-2a (Pegasys) treatment.”

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Department of Medicine and Hepatology, Henry Dunant Hospital, Athens, Greece Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China Service D’Hépatologie, INSERM Unite 481 and Centre de Recherches Claude Bernard sur les Hépatites Virales, Hôpital Beaujon, Clichy, France Department of Medicine, Songklanakarin Hospital, Songkla, Thailand Clinical Research Department, Royal Brisbane Hospital, Brisbane, Australia IRCCS, Ospedale Maggiore di Milano Policlinico, Milan, Italy Department of Medicine, Pramongkutklao Hospital, Bangkok, Thailand Seccion de Hepatologia, Hospital General Universitario de Valencia, Valencia, Spain Digestive Disease Department, Beijing You An Hospital, Beijing, China Roche, Welwyn, UK

04/18/05

Reference S Hadziyannis and others. SUSTAINED HBSAG SEROCONVERSION IN PATIENTS WITH CHRONIC HEPATITIS B TREATED WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®). Abstract 491(poster). 40th EASL. April 13-17, 2005. Paris, France.