Background/aims: The purpose of this prospective case-control study was to evaluate the clinical effects and host immune response in patients with chronic hepatitis B (CHB) treated with either entecavir (ETV)or adefovir dipivoxil (ADV).
Methodology: Forty-two patients diagnosed with CHB were recruited and randomly assigned to receive either ADV (n=19) or ETV(n=18) and were followed for a minimum of 96 weeks.Serum hepatitis B virus (HBV) DNA, hepatitis B e antigen and antibody (HBeAg, HBeAb), alanine amino-transferase (ALT) and aspartate aminotransferase(AST) were measured at baseline and every 24 weeks until study completion. After 96 weeks of therapy, regulatory T-cells (Tregs) were measured in the patients treated with ETV or ADV.
Results: Significant decreases in serum ALT, AST and HBV DNA, but not in HBeAgor HbeAb, were noted in the treatment group. The ra-tios of CD4+CD25+ and CD4+CD25+CD45RO+CD125+in CD4+ T-cells were significantly higher in the untreated group compared to those in the ETV and ADV groups. Treg profiles were significantly altered in CHB patients after 96 weeks of nucelos(t)ide therapy HBV-infected individuals.
Conclusions: Study results support the hypothesis that Tregs play a role in regulating the immune response in patients with CHB.