Long-term efficacy of interferon alpha-2b and lami

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SEPTEMBER  2001 VIRAL HEPATITIS B- 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



G. Barbaro (1), . Zechini 2, A. M. Pellicelli (2), R. Francavilla (3), G. Scotto (4), D. Bacca (5), M. Bruno (6), S. Babudieri (7), M. Annese (8), F. Matarazzo (9), G. Di Stefano (10), G. Barbarini and for the Lamivudine Italian Study Group Investigators (11)



(1) Department of Emergency Medicine, University `La Sapienza', Rome, Italy

(2) Clinical Department of Infectious Diseases, Lazzaro Spallanzani Hospital, Rome, Italy

(3) Division of Infectious Diseases, General Hospital, Bisceglie, Italy

(4) Division of Infectious Diseases, General Hospital, Foggia, Italy

(5) Division of Gastroenterology, General Hospital, Casarano, Italy

(6) Division of Infectious Diseases, Guadagna Hospital, Palermo, Italy

(7) Institute of Infectious Diseases, University of Sassari, Sassari, Italy

(8) Division of Gastroenterology, General Hospital, Matera, Italy

(9) Division of Infectious Diseases, General Hospital, Formia, Italy

(10) Division of Infectious Diseases, General Hospital, Latina, Italy

(11) Department of Infectious and Tropical Diseases, Policlinico S. Matteo, University of Pavia, Pavia, Italy



Background/Aims: To evaluate the therapeutic efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B.

Methods: One hundred and fifty-one patients were randomly assigned to receive either recombinant interferon alpha-2b (nine million units three times per week) and lamivudine (100mg/daily per os) for 24 weeks or lamivudine alone (100mg/daily per os) for 52 weeks. Patients were followed up for a further 48 weeks.

Results: Sustained HBeAg seroconversion with undetectable serum levels of HBV 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 patients (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 seroconversion compared to 1-year lamivudine monotherapy. However, the potential benefit of combining lamivudine and interferon should be investigated further in studies with different regimens of combination therapy. (J. Hepatol., 35, 3, 406-411,2001)