BACKGROUND: The efficacy of pegylated interferon alfa-2b alone or in combination with lamivudine for the treatment of patients with hepatitis B e antigen (HBeAg) negative (-) chronic hepatitis B (CHB) is understudied. MATERIAL/METHODS: One hundred twenty-six patients with HBeAg(-)chronic hepatitis B received pegylated interferon alfa-2b > or =1.5 micro g/kg/wk for 48 weeks. Ninety of those subjects were randomly selected to receive concomitant treatment with lamivudine 100 mg/d. The coprimary end points were the subjects' virologic (hepatitis B virus deoxyribonucleic acid HBV DNA <60 IU/mL) and biochemical (normalization of alanine aminotransferase levels) responses 24 weeks after treatment cessation. RESULTS: The scores for necroinflammatory activity and fibrosis in patients randomly assigned to receive monotherapy were statistically significantly lower than those in patients receiving combination therapy. HBV DNA levels were statistically significantly higher and alanine aminotransferase levels were statistically significantly lower in patients receiving monotherapy than in those receiving combination therapy. Virologic responses in the monotherapy and combination therapy groups were similar at weeks 48 and 72 (59.1 vs 42.9). The biochemical response at week 72 was also similar in the treatment groups. The results of multiple regression analysis showed that the virologic response at week 72 was independently correlated with the pegylated interferon alfa-2b dose and that the biochemical response was independently correlated with necroinflammatory activity, the pegylated interferon alfa-2b dose, and lamivudine therapy. CONCLUSIONS: These data support the use of pegylated interferon alfa-2b in patients with HBeAg(-) chronic hepatitis B; however, the concomitant use of lamivudine produced no additional clinical benefit.
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