Aim: To compare interferon monotherapy with combination treatment using interferon and lamivudine in children with chronic hepatitis B.
Methods: Data from 65 children who had received either interferon-alpha (5 MU/m2 subcutaneous thrice a week for 6 months; n=35; Group 1) or this dose of interferon-alpha for 6 months with oral lamivudine for one year (4 mg/Kg/day, maximum 100 mg/day; n=30; Group 2) were analyzed retrospectively. Complete response was defined as ALT normalization, HBeAg/anti-HBe seroconversion and HBV DNA clearance.
Results: ALT normalization rates were similar in Groups 1 and 2 at the end of interferon treatment (13 [38%] and 16 [52%], respectively), at 12 months (19 [56%] and 18 [58%]) and at 24 months (24 [71%] and 23 [74%]). HBV DNA clearance was more frequently observed at 6 months in Group 2 than in Group 1 (19 [63%] versus 7 [20%]; p=0.01), but not at 12 months (19 [63%] versus 17 [49%]) or at 24 months (20 [67%] versus 21 [60%]). Rate of HBeAg/anti-HBe seroconversion was higher in Group 2 at 12 months (18 [60%] versus 11 [31%]; p< 0.05). Rate of complete response was similar in Groups 1 and 2 at 6 months (5 [14%] and 10 [33%], respectively), 12 months (14 [40%] and 17 [57%]) and 24 months (20 [57%] and 19 [63%]).
Conclusion: Although lamivudine and interferon combination achieved higher initial rates of HBV DNA loss and HBeAg/anti-HBe seroconversion than interferon alone, the final response rates were similar with the two treatments. The combination treatment is therefore not indicated for chronic hepatitis B in children.
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