Durability of peginterferon alfa‐2b treatment at 5 years in patients with hepatitis B e antigen–positive chronic hepatitis B

Approximately 30%‐40% of patients with hepatitis B e antigen (HBeAg)‐positive chronic hepatitis B treated with peginterferon and/or lamivudine achieve HBeAg seroconversion 6 months after the end of treatment. The durability and long‐term effect of treatment are unknown. In this study, 85 HBeAg‐positive patients who received peginterferon alfa‐2b 1.5 μg/kg/week for 32 weeks and lamivudine 100 mg/day for 52 or 104 weeks were prospectively followed for 6.1 ± 1.7 years posttreatment. Twenty‐five (29%) patients had virologic response (HBeAg seroconversion and HBV DNA <10,000 copies/mL) at 5 years. The rate of HBeAg seroconversion rose progressively from 37% at the end of treatment to 60% at 5 years. Twenty‐seven (32%) and 11 (13%) patients had undetectable HBV DNA (<100 copies/mL) at the end of peginterferon treatment and at 5 years, respectively. Two (2.4%) patients achieved hepatitis B surface antigen (HBsAg) seroclearance at 2.6 and 84 months posttreatment. Among virologic responders at the end of treatment, 82% and 57% and sustained HBeAg seroconversion and virologic response at 5 years. End‐of‐treatment serum quantitative HBsAg was significantly lower in patients with sustained virologic response at 5 years (median 1,431 IU/mL versus 2,689 IU/mL [ P = 0.041]). At the last follow‐up, the liver stiffness measurement by transient elastography was 5.8 ± 2.7 kPa. Only two patients had liver stiffness suggestive of advanced fibrosis. Week 16 HBV DNA, end‐of‐treatment HBeAg seroconversion, and undetectable HBV DNA were independent factors associated with virologic response at 5 years. The duration of concomitant lamivudine treatment had no impact on any long‐term response. Conclusion: Peginterferon has high durability in HBeAg‐positive chronic hepatitis B patients with end‐of‐treatment virologic response. (Hepatology 2010;)