Background/aims: Immune-modulator and antiviral treatments for carriers of hepatitis B virus are known to have poor efficacy with a high cost and frequent side effects, which has led to investigation of new treatment modalities. The aim of this study was to determine the efficacy of recombinant hepatitis B vaccine in the treatment of patients with chronic hepatitis B (HBV DNA >5 pg/ml, ALT>60) infection diagnosed histopathologically and asymptomatic carriers (HBV DNA<5 pg/ml, ALT <40, Anti Hbe positive) of the virus.
Methods: The vaccine (Gen Hevac B Pasteur) was administered at baseline and at months one and six to patients with chronic hepatitis and asymptomatic carriers. Ten cases with chronic hepatitis B infection were assigned to a control group to whom no treatment was given. Biochemical and microbiological investigations were performed at baseline and at months three, six and twelve in all cases. Seroconversion of Hbe Ag, loss of HBV DNA and normalization of ALT were considered as a positive response.
Results: Patients with chronic hepatitis B who were given the vaccine were found to have significantly low levels of HBV DNA at 12 months (63.2+/-20pg/ml) compared to baseline values (174.4+/-36.9pg/ml), while controls were found to have high levels of HBV DNA at 12 months (223.1+/-33pg/ml) compared to baseline values (165.2+/-33.2pg/ml) (p<0.05). At 12 months, HBV DNA had become negative in seven of 19 patients given the vaccine (36.8%) Four patients with chronic hepatitis (36.35%) were observed to have HBeAg seroconversion and one patient (5.2%) HBsAg seroconversion at the end of 12 months and there were four (21.05%) patients who responded positively to vaccine therapy in this group. Asymptomatic carriers and controls did not have seroconversion of HBs Ag. Also, HBV DNA did not become negative in controls.
Conclusion: It may be concluded that recombinant hepatitis B vaccine is effective in the treatment of chronic hepatitis B.