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Volume 136, Issue 7 , Pages 2169-2179.e4, June 2009

Sustained Response of Hepatitis B e Antigen-Negative Patients 3 Years After Treatment with Peginterferon Alfa-2a

Patrick Marcellin
- Service d'Hépatologie, U773-CRB3, Hôpital Beaujon, University of Paris, Clichy, France
- Reprint requests Address requests for reprints to: Prof Patrick Marcellin, Service d'Hépatologie and INSERM U773-CRB3, Hôpital Beaujon, Clichy, France. 100 boulevard du Général Leclerc, 92110 Clichy, France. fax: xxx
Ferruccio Bonino
- Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico di Milano, Italy
George K.K. Lau
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China
Patrizia Farci
- Universita di Cagliari, Cagliari, Italy
Cihan Yurdaydin
- University of Ankara, Faculty of Medicine, Ankara, Turkey
Teerha Piratvisuth
- NKC Institute of Gastroenterology and Hepatology, Department of Internal Medicine, Songklanagarind Hospital, Prince of Songkla University, Hat Yai 90110, Thailand
Rui Jin
- Digestive Department, Beijing You-An Hospital, Beijing, China
Selim Gurel
- Department of Gastroenterology, Uludag University, Bursa, Turkey
Zhi-Meng Lu
- Department of Infectious Diseases, Ruijin Hospital, Shanghai, China
Jian Wu
- Roche, Dee Why, Australia
Matei Popescu
- F. Hoffman-La Roche, Basel, Switzerland
Stephanos Hadziyannis
- Department of Medicine and Hepatology, Henry Dunant Hospital, Athens, Greece
Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group

Received 13 June 2008; accepted 2 March 2009. published online 20 March 2009.

Background & Aims

Patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B treated with peginterferon alfa-2a with or without lamivudine achieve significantly higher 6-month posttreatment rates of response compared with those treated with lamivudine alone. The durability of ≤3-year posttreatment response was investigated in this study.

Methods

Patients received peginterferon alfa-2a only (180 μg once weekly; n = 177), in combination with lamivudine (100 mg daily; n = 179) or lamivudine alone (n = 181) for 48 weeks. A total of 315 patients (116, 114, and 85, respectively) participated in this posttreatment observational study.

Results

Three years after treatment, the percentage of patients with normal alanine aminotransferase (ATL) was higher for patients treated with peginterferon alfa-2a (31%) than with lamivudine (18%; P = 0.032). Similarly, 28% of patients treated with peginterferon had hepatitis B virus (HBV) DNA levels ≤ 10,000 copies/mL versus 15% of patients treated with lamivudine (P = .039). Peginterferon alfa-2a treatment and high baseline ALT level were independent baseline predictors of long-term virologic response (P = .040 and P = .01, respectively). Of the patients who had been treated with a peginterferon alfa-2a–containing regimen, 8.7% cleared hepatitis B surface antigen (HBsAg; 44% of those with undetectable HBV at 3-year posttreatment follow-up) compared with none treated with lamivudine alone.

Conclusions

Biochemical and virologic responses were sustained for ≤3 years in approximately 25% of patients given a 48-week course of peginterferon alfa-2a, with or without lamivudine. The increased rate of HBsAg clearance in patients with HBeAg-negative chronic hepatitis B supports the use of peginterferon alfa-2a as a first-line treatment.

Abbreviations used in this paper: ALT, alanine aminotransferase, CHB, chronic hepatitis B, HBeAg, hepatitis B e antigen, HBsAg, hepatitis B surface antigen, HBV, hepatitis B virus, ULN, upper limit of normal

This article has an accompanying continuing medical education activity on page 2388. Learning Objective: Upon completion of this exercise, successful learners will be able to assess the likelihood of sustained response, 3 years post-treatment in patients with HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a, and will be able to utilize this knowledge when assessing the potential treatment options and deciding upon the most appropriate course of management for their patients with chronic hepatitis B.

Conflicts of interest The authors disclose the following: Dr Marcellin has received consulting and lecture fees from Roche, and grants from Roche, Dr Bonino has received consulting fees from Roche; Dr Lau received consulting fees from Roche, and GlaxoSmithKline, and lecture fees from Roche, and GlaxoSmithKline, Dr Farci has received consulting fees from Roche; Dr Yurdaydin, Dr Piratvisuth, Dr Jin, Dr Gurel, Dr Hadziyannis, and Dr Lu have received grant support from Roche. Mr Wu and Dr Popescu report being employees of Roche.

Funding Supported by a research grant from F. Hoffmann-La Roche, Basel, Switzerland.

PII: S0016-5085(09)00377-1

doi:10.1053/j.gastro.2009.03.006