A partially overlapping treatment course with lamivudine and interferon in hepatitis B e antigen‐negative chronic hepatitis B

<jats:sec><jats:title>Summary</jats:title></jats:sec><jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Aim</jats:title><jats:p>To investigate the efficacy of a lamivudine–interferon combination therapy in 36 patients HBeAg‐negative CHBe−.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Lamivudine was administered from 1 to 12 months and interferon‐<jats:italic>α</jats:italic>2b 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‐<jats:italic>α</jats:italic>2b was used. All patients were followed up for ≥12‐month post‐treatment.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The biochemical response rate at the end of treatment was 78% in lamivudine–interferon and 52.8% in interferon–control group (<jats:italic>P</jats:italic> = 0.026) and at 12‐month post‐treatment 38.9% and 22.2%, respectively (<jats:italic>P</jats:italic> = 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 (<jats:italic>P</jats:italic> =0.093) and in 22.2% and 13.9% of patients, respectively, at 12‐month post‐treatment (<jats:italic>P</jats:italic> = 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 (<jats:italic>P</jats:italic> = 0.017) and in 8.3% and 0% of patients, respectively, at 12‐month post‐treatment (<jats:italic>P</jats:italic> = 0.076).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec>