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Randomized Controlled Trial
. 2009 Jun;136(7):2169-2179.e1-4.
doi: 10.1053/j.gastro.2009.03.006. Epub 2009 Mar 19.

Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a

Patrick Marcellin  1 , Ferruccio Bonino, George K K Lau, Patrizia Farci, Cihan Yurdaydin, Teerha Piratvisuth, Rui Jin, Selim Gurel, Zhi-Meng Lu, Jian Wu, Matei Popescu, Stephanos Hadziyannis; Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a

Patrick Marcellin et al. Gastroenterology. 2009 Jun.

Abstract

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

Methods: Patients received peginterferon alpha-2a only (180 microg 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 alpha-2a (31%) than with lamivudine (18%; P = 0.032). Similarly, 28% of patients treated with peginterferon had hepatitis B virus (HBV) DNA levels <or= 10,000 copies/mL versus 15% of patients treated with lamivudine (P = .039). Peginterferon alpha-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 alpha-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 <or=3 years in approximately 25% of patients given a 48-week course of peginterferon alpha-2a, with or without lamivudine. The increased rate of HBsAg clearance in patients with HBeAg-negative chronic hepatitis B supports the use of peginterferon alpha-2a as a first-line treatment.

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