Source Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.
BACKGROUND: The reduction of hepatitis B virus replication to minimal levels is emerging as key therapeutic goal in chronic hepatitis B (CHB).
OBJECTIVES: This study aimed to evaluate and compare the efficacies of adefovir (ADV) and entecavir (ETV) in CHB.
PATIENTS AND METHODS: In this prospective study, 100 naïve patients were assigned to treatment with ADV (33 HBeAg-positive and 19 HBeAg-negative patients) or ETV (32 HBeAg-positive and 16 HBeAg-negative patients). The primary efficacy outcome was ALT normalization, reduction in HBV DNA, and seroconversion of HBeAg. Second efficacy outcomes included resistance and safety. Comparisons of quantitative and qualitative variables between groups were analyzed by student t-test and chi-square test (or Fisher's exact test), respectively.
RESULTS: Among HBeAg-positive patients, ETV was superior to ADV with respect to mean reduction in HBV DNA (-7.5 versus -6.3, respectively, at Month 24, p = 0.003) and the percentage of those with HBV DNA < 103 copies/mL at Month 24 [96.9% (31/32) vs. 69.7% (23/33), respectively, p = 0.002] and < 300 copies/mL at Month 24 [84.4% (27/32) vs. 54.5% (18/33), respectively, p = 0.004]. But, the rates of ALT normalization and HBeAg seroconversion between the groups were similar [87.9% (29/33) vs. 96.9% (31/32), respectively, p=0.355; and 24.2% (8/33) vs. 25.0% (8/32), respectively, p = 0.943]. In HBeAg-negative patients who received ETV or ADV, the reduction in HBV DNA (-6.8 versus -5.9, respectively, p = 0.192), percentage of ALT normalization [100% (16/16) vs. 78.9% (15/19), respectively, p=0.109], HBV DNA < 103 copies/mL [100% (16/16) vs. 89.5% (17/19), respectively, p = 0.489], and HBV DNA < 300 copies/mL [100% (16/16) vs. 84.2% (16/19), respectively, p = 0.234] were similar. No ETV- or ADV-associated mutations were observed, and both agents were well tolerated.
CONCLUSIONS: ETV and ADV are effective therapies for CHB. In HBeAg-positive patients, the efficacy of ETV is significantly superior to that of ADV, and in HBeAg-negative patients, the agents effect similar biochemical and virological responses.