Comparison of lamivudine - α-interferon combination and α-interferon alone treatments in adult patients with naive HBeAg negative hepatitis B

Objectives: This study aimed to compare the efficacy of the α-interferon treatment with α-interferon plus lamivudine for cases of chronic hepatitis B. Materials and methods: Sixty-one HBeAg negative naive chronic hepatitis B patients were randomly evaluated in two groups prospectively. In group 1, 30 patients were simultaneously given α-interferon 2a 9 MU, 3 days a week by s.c. injection plus lamivudine 100 mg a day for 12 months. In group II, there were 31 patients who only was received the same dosage of α-interferon and no lamivudine over the same period of time. Results: In group 1 the initial mean value of alanine aminotransferase (ALT) was 144±59 IU/L and decreased to 38.8±19.3 IU/L; in group II, initial mean values of ALT was 141±52 IU/L and decreased to 53.2±14.7 IU/L at the end of 12th month of the therapy (P<0.05). Hepatitis B virus DNA (HBV-DNA) clearance was obtained in 13 of 30 patients (43.3%) in group I patients and 15 of 31 (48.4%) in group II at the end of the therapy (p=0.692). The number of patients with complete response was found to be 14 out of 30 (48.4%) in group 1 and 15 out of 31 cases (46.7%) in group II, six months after the end of the therapy (P=0.893). Conclusion: α-interferon and lamivudine combination therapy had a more beneficial effect than α-interferon monotherapy in normalization of ALT and clearance of HBV-DNA; however, the complete response rate at 6 months after the end of the therapy was not statistically significantly different between both groups.