VACCINATION AGAINST HEPATITIS-B VIRUS - A N EFFICIENT IMMUNOTHERAPY AGAINST HEPATITIS-B MULTIPLICATION

In a prospective, non-randomized, pilot study, we evaluated the effica cy of hepatitis B virus (HBV) vaccination in inhibiting HBV replicatio n of chronic hepatitis B. Fourteen consecutive chronic HBs antigen car riers received standard vaccination with three injections of the GenHe vac B(R) vaccine, one month apart. All the patients had active HBV rep lication with chronic hepatitis but not cirrhosis. They were compared to a historical group of 34 patients who fullfilled the same inclusion criteria. Over the 6-month follow-up period after the first injection , serum HBV DNA became undetectable in 3 patients (21.4 %). Four addit ional patients (28.6 %) showed a significant decrease in HBV replicati on. In 4 cases, the disappearance of or decrease in HBV DNA was preced ed by an increase in transaminase activities, which was also observed in one patient who did not modify his viral replication. Vaccination w as otherwise uneventful. By contrast, during a mean follow-up of 40 mo nths, only 3 (9 %) of the 34 unvaccinated patients who served as contr ols lost serum HBV DNA, giving a 6-month HBV DNA disappearance rate of 1 %. In sum, vaccination appeared able to reduce or stop HBV replicat ion in half of the chronic HBsAg carriers with chronic hepatitis. This additional therapeutic tool may enhance the rate of response to inter feron-alpha therapy, which is dependent on the level of HBV replicatio n. Thus, immunotherapy should be considered of potential importance fo r the treatment of HBV infection.