Background and aim: Lamivudine (LAM) has problems of breakthrough hepatitis (BTH) and post-treatment relapse despite its significant effect for suppressing hepatitis B virus (HBV) replication. In order to find solutions for the problems, the efficacy of combination therapy of LAM plus hepatitis B (HB) vaccine in patients with chronic HBV infection was assessed.
Patients and methods: Fifty-three patients with chronic hepatitis B, 33 hepatitis B e-antigen positive (HBeAg+), and 20 HBeAg negative (HBeAg-) patients, were enrolled in the study, and randomized to receive either LAM monotherapy or combination therapy of LAM and HB vaccine. In the combination therapy group, 100 mg/day of LAM was administered as a baseline therapy, and 10 mug of HB vaccine was injected subcutaneously every month starting at 2 months after LAM administration, six times in total.
Results: HBeAg negative patients responded well to LAM therapy, and there were no significant differences in short-term effects between the two therapy groups. With regard to the ratio of developing BTH, there was no difference betweenthe two groups. In HBeAg+ patients, HBV replication was suppressed more efficiently in the combination therapy group than in the monotherapy group. The ratio of developing BTH was significantly lower in the combination therapy group than in the monotherapy group. Regardless of HBeAg serologic status or therapy protocols, post-treatment relapse was seen in most patients when the administrations of LAM were discontinued. No adverse effect with the use of HB vaccine was observed in all the patients treated with the combination therapy.
Conclusion: Combination therapy of LAM and HB vaccine is a safe and effective way to control HBV replication and prevent the development of BTH especially in patients with high viral load. However, further study is required in order to achieve the continuous suppression of HBV replication even after cessation of LAM.