Background: Lamivudine is a new alternative therapeutic agent for chronic hepatitis B, in which alpha interferon (IFN-α) monotherapy is not successful enough. Published reports have revealed no satisfactory data on IFN-α and lamivudine combination therapy in children. The aim of this study is to investigate the efficacy and safety of this combination therapy in children with chronic hepatitis B.
Methods: Children with chronic hepatitis B were given either IFN-α and lamuvidine (group 1, n = 47) or IFN-α alone (group 2, n = 30). Alpha interferon was administered as 5 million U/m2 s.c., thrice a week for 6 months and lamivudine 4 mg/kg per day p.o., maximum 100 mg, for 1 year. Clinical examination was performed; blood cell counts and serum alanine aminotransferase (ALT) and amylase were studied at each visit. At the third, sixth and twelfth month, serological markers were determined.
Results: End of therapy response was achieved in 19 (40.4%) patients in group 1 and in 14 (46.7%) children in group 2 (P > 0.05). In group 1, pretreatment serum ALT and hepatic activity index (HAI) were statistically higher in children who responded to therapy (P < 0.005). In group 2, mean serum ALT was higher and hepatitis B virus (HBV) DNA was lower in responders. Sustained response rate was 40.4 versus 43.3% in two groups.
Conclusion: The response rate of IFN-α and lamivudine combination therapy in children with chronic hepatitis B was similar to that of IFN-α monotherapy. High ALT level and HAI, rather than low HBV-DNA level were found to be important predictors of response.