Background: The aim of our study was to compare the efficacy of combined interferon-alpha and lamivudine in children with chronic hepatitis B infection and two durations of treatment (6 and 12 months).
Methods: Combination of interferon-alpha 2b (10 MU/m2 of body surface) and lamivudine 4 mg/kg (maximum, 100 mg) were given synchronously to 30 patients for 6 months (Group 1) and to 27 patients for 12 months (Group 2). Biochemical, virologic and serologic features were compared between two groups at the end of therapy and 6 months after therapy.
Results: Hepatitis B e antigen clearances were 33 and 59% at the end of treatment and 37 and 56% 6 months after therapy in Groups 1 and 2, respectively (P > 0.05). Hepatitis B virus DNA clearances were 97 and 100% at the end of treatment and 97 and 96% 6 months after therapy in Groups 1 and 2, respectively (P > 0.05). In both groups normalization of alanine aminotransferase was maintained at the end of therapy and 6 months after therapy (P < 0.05). Sustained complete responses were obtained in 20 and 37% of patients at the end of therapy and 6 months after therapy, respectively (P = 0.07).
Conclusions: When the combination of large dosage interferon-alpha 2b and lamivudine therapy in children was compared at the end of therapy and 6 months after therapy, normalization of alanine aminotransferase and the clearances of hepatitis B e antigen and hepatitis B surface antigen in both groups were directly proportional to the duration of treatment. However, the higher complete response rate at 12 months of combination therapy was not statistically different from that at 6 months.