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Sustained Response in HBeAg Negative Chronic Hepatitis B Patients 3 Years After Treatment with Pegasys

About one-quarter of hepatitis B "e" antigen (HBeAg) negative patients treated with pegylated interferon alfa-2a (Pegasys) for 48 weeks continued to demonstrate sustained biochemical and virological responses up to 3 years after completing therapy, according to a study in the June 2009 issue of Gastroenterology.

By Liz Highleyman

Investigators with the international Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group randomly assigned more than 500 HBeAg negative chronic hepatitis B patients to received 180 mcg/week pegylated interferon monotherapy, 100 mg/day lamivudine (Epivir) monotherapy, or the same doses of both drugs used in combination, all for 48 weeks.

The researchers previously reported that HBeAg negative patients treated with pegylated interferon, with or without lamivudine, achieved significantly higher rates of sustained response 6 months after completing therapy than individuals treated with lamivudine alone.

In the present analysis, the authors looked at long-term durability though 3 years after treatment completion. A total of 315 patients (59% of the original patient population) participated in the post-treatment observational study.

Results

3 years after treatment, 28% of patients treated with pegylated interferon (with or without lamivudine) had HBV DNA levels <10,000 copies/mL, compared to 15% of patients treated with lamivudine monotherapy (P = 0.039).
Similarly, more patients treated with pegylated interferon had normal alanine aminotransferase (ALT) at the end of follow-up compared to those treated with lamivudine monotherapy (31% vs 18%; P = 0.032).
Use of pegylated interferon and high baseline ALT were independent predictors of long-term virological response (P = 0.040 and 0.01, respectively).
Among participants treated with pegylated interferon (again, with or without lamivudine), 8.7% overall -- or 44% of those with undetectable HBV at the end of follow-up -- cleared hepatitis B surface antigen (HBsAg), versus none treated with lamivudine monotherapy.

Based on these findings, the study authors concluded, "Biochemical and virologic responses were sustained for <3 years in approximately 25% of patients given a 48-week course of peginterferon alpha-2a, with or without lamivudine."

In their discussion, they added, "The ability to induce HBsAg clearance -- an outcome that is associated with long-term complication-free survival -- supports the use of peginterferon alfa-2a as a first-line treatment of HBeAg negative disease, avoiding the need for long-term therapy and the associated risks of developing drug resistance in those patients who achieve and maintain their response."

Drug resistance is a known risk with lamivudine and other nucleoside/nucleotide analogs that directly target HBV. Interferon is less likely to be limited by resistance since it promotes immune response against HBV rather than interfering directly with the viral life-cycle.

Service d'Hépatologie, Hôpital Beaujon, University of Paris, Clichy, France; Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico di Milano, Italy; Queen Mary Hospital, University of Hong Kong, Hong Kong, China; Universita di Cagliari, Cagliari, Italy; University of Ankara, Faculty of Medicine, Ankara, Turkey; NKC Institute of Gastroenterology and Hepatology, Department of Internal Medicine, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand; Digestive Department, Beijing You-An Hospital, Beijing, China; Department of Gastroenterology, Uludag University, Bursa, Turkey; Department of Infectious Diseases, Ruijin Hospital, Shanghai, China; Department of Medicine and Hepatology, Henry Dunant Hospital, Athens, Greece; Roche, Dee Why, Australia; F. Hoffman-La Roche, Basel, Switzerland.

8/18/09

Reference

P Marcellin, F Bonino, GK Lau and others (for the Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group). Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. Gastroenterology 136(7): 2169-2179. June 2009. (Abstract).