Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial

Background/Aims: To evaluate the therapeutic efficacy of interferon alpha-2 b and lamivudine in combination compared to lamivudine monotherapy in patie nts with chronic hepatitis B. Methods: One hundred and fifty-one patients were randomly assigned to recei ve either recombinant interferon alpha-2b (nine million units three times p er week) and lamivudine (100 mg/daily per os) for 24 weeks or lamivudine al one (100 mg/daily per os) for 52 weeks. Patients were followed up for a fur ther 48 weeks. Results: Sustained HBeAg seroconversion with undetectable serum levels of H BV DNA was observed in 25 of 76 patients (33%) treated with the combination therapy and in 11 of 75 patients (15%) treated with monotherapy (P=0.014). Histological improvement defined as a reduction of at least two points in the inflammation score as compared with pretreatment score was observed in 35 of 76 patients (46%) treated with combination therapy and in 20 of 75 pa tients (27%) treated with monotherapy (P=0.021). Both therapeutic regimens were well tolerated. Conclusions: Six-month treatment with interferon alpha-2b and lamivudine in combination appeared to increase the rate of sustained HBeAg seroconversio n compared to 1-year lamivudine monotherapy. However, the potential benefit of combining lamivudine and interferon should be investigated further in s tudies with different regimens of combination therapy. (C) 2001 European As sociation for the Study of the Liver. Published by Elsevier Science B.V. Al l rights reserved.