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Summary

Background

Treatment of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHBe-) with interferon or lamivudine alone is inefficient and reports of combination treatment with both drugs, equivocal so far.

Aim

To investigate the efficacy of a lamivudine–interferon combination therapy in 36 patients HBeAg-negative CHBe−.

Methods

Lamivudine was administered from 1 to 12 months and interferon-α2b from 7 to 18 months. A historical control group of 36 CHBe− patients, matched for age and sex and treated with the same dosage of interferon-α2b was used. All patients were followed up for ≥12-month post-treatment.

Results

The biochemical response rate at the end of treatment was 78% in lamivudine–interferon and 52.8% in interferon–control group (P = 0.026) and at 12-month post-treatment 38.9% and 22.2%, respectively (P = 0.125). Alanine aminotransferase normalization and serum HBV-DNA levels ≤30 000 cp/mL were observed in 50.0% of lamivudine–interferon-treated and 30.6% of interferon-treated patients at the end of treatment (P =0.093) and in 22.2% and 13.9% of patients, respectively, at 12-month post-treatment (P = 0.358). Moreover, alanine aminotransferase normalization and undetectable serum HBV-DNA (<400 cp/mL) was observed in 30.6% of lamivudine–interferon-treated and 8.3% of interferon-treated patients at the end of treatment (P = 0.017) and in 8.3% and 0% of patients, respectively, at 12-month post-treatment (P = 0.076).

Conclusions

In CHBe−, 12 months after ending a lamivudine–interferon partially overlapping 18-month combination course, 22% of patients still maintain normal alanine aminotransferase and HBV-DNA levels ≤30 000 cp/mL. However, a 12-month interferon monotherapy course may achieve similar responses.