Objective: To investigate whether simultaneous commencement of peginterferon alpha-2b and lamivudine treatment has more potent hepatitis B virus (HBV) DNA suppression than staggered regimes.
Methods: Thirty HBeAg-positive chronic hepatitis B patients were randomized in 1:1:1 ratio to 32-week peginterferon started simultaneously with lamivudine (group 1), eight weeks before lamivudine (group 2) or eight weeks after commencement of lamivudine (group 3). All patients received lamivudine until week 104.
Results: At week 52, the log HBV DNA reduction in group 1 (6.38) was more profound than that in group 2 (3.43, P = 0.022) and tended to be superior to that in group 3 (4.44, P = 0.060). HBeAg seroconversion developed in six (67%) patients in group 1, three (33%) patients in group 2 (P = 0.35 versus group 1) and one (10%) patient in group 3 (P = 0.037 versus group 1). At week 104, the log HBV DNA reduction in group 1 (6.13) versus that in group 2 (5.24) and group 3 (5.15) was insignificantly different. Lamivudine resistance was found in four (14%) patients at week 104. There was 1.22 and 2.52 median log reduction in covalently closed circular DNA and total intrahepatic HBV DNA, respectively, at week 104, but there was no difference among the three groups. At 24 weeks post-treatment, sustained HBeAg seroconversion was observed in five (56%), three (33%) and four (40%) of the patients in groups 1, 2 and 3, respectively (P > 0.05).
Conclusions: Simultaneous commencement of peginterferon and lamivudine tend to provide more profound viral suppression than staggered regimes in the early phase of treatment.