[Efficacy of immunotherapy with vaccination against hepatitis B virus on virus B multiplication]

In a prospective, non-randomized, pilot study, we evaluated the efficacy of hepatitis B virus (HBV) vaccination in inhibiting HBV replication of chronic hepatitis B. Fourteen consecutive chronic HBs antigen carriers received standard vaccination with three injections of the GenHevac B vaccine, one month apart. All the patients had active HBV replication with chronic hepatitis but not cirrhosis. They were compared to a historical group of 34 patients who fulfilled 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 additional patients (28.6%) showed a significant decrease in HBV replication. In 4 cases, the disappearance of or decrease in HBV DNA was preceded by an increase in transaminase activities, which was also observed in one patient who did not modify his viral replication. Vaccination was otherwise uneventful. By contrast, during a mean follow-up of 40 months, only 3 (9%) of the 34 unvaccinated patients who served as controls lost serum HBV DNA, giving a 6-month HBV DNA disappearance rate of 1%. In sum, vaccination appeared able to reduce or stop HBV replication in half of the chronic HBsAg carriers with chronic hepatitis. This additional therapeutic tool may enhance the rate of response to interferon-alpha therapy, which is dependent on the level of HBV replication. Thus, immunotherapy should be considered of potential importance for the treatment of HBV infection.