ABSTRACT
Objective To investigate the efficacy of individualized interferon (IFN)-alpha therapy in HBeAg-negative chronic hepatitis B patients. Methods Seventy- six Chinese HBeAg-negative chronic hepatitis B patients proven by liver biopsy were treated with 5 MU recombinant IFN-alpha 1b subcutaneously thrice every week. All the patients were followed up for at least 24 months the combined responses were defined as normalization of serum alanine transaminase (ALT) and HBV DNA＜3 log10 copy/mL. An intention-to-treat (ITT) analysis was used in this paper in which all 76 patients were included. Results Six patients were lost. Treatment duration was in the range 2-24 months with a median of 8.5 months, and combined responses were achieved at a median of 6.0 months (range 2-19 months) of treatment duration.Seventy-five-percentile of treatment duration to endpoints was 10.0 months. The combined response rate was 46.1% (35/76) at the end of treatment, 43.3% (33/76) at 12-month follow-up and 40.8% (31/76) at 24-month follow-up. The relapse rate was 20. 0% (7/35) and 25. 7% (9/35) at 12-month and 24-month follow-up, respectively. Higher necroinflammatory activity in liver biopsy predicted a good response, while gender, age, liver fibrosis, baseline ALT, aspartate aminotransferase levels and baseline HBV DNA levels were not impact factors of therapeutic effects by binary Logistic regression analysis.Conclusion Individualized prolonged IFN-alpha regimen lead to considerable sustained disease suppression in patients with HBeAg-negative chronic hepatitis B.
