Therapeutic Vaccination in Chronic Hepatitis B

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MARCH  2002 VIRAL HEPATITIS B-Therapeutic Vaccination in Chronic Hepatitis B



H. Senturk, F. Tabak, M. Akdogan, L. Erdem, A. Mert, R. Ozaras, E. Sander, G. Ozbay, S. Badur



Departments of Internal Medicine, Clinical Bacteriology and Infectious diseases and Pathology, Cerrahpasa Medical faculty, University of Istanbul; Departments of Gastroenterology, Ankara Yuksek Ihtisas Sisli Etfal and SSK Istanbul Hospitals; Department of Virology, Medical Faculty, Istanbul University, Istanbul, Turkey.



Aims: The aim was to test the efficacy of a pre-S2-containing vaccine (Genhevac-B) in chronic hepatitis B (CHB). Twenty-five naive patients (22 male, three female; median age 35; range: 6-69 years) with CHB were recruited. The inclusion criteria were: hepatitis B e antigen (HBeAg) positive or HBV-DNA detectable with liquid hybridization; alanine aminotransferase (ALT) is at least 1.5-fold the upper normal limit and histological evidence of chronic hepatitis.

Methods: In the first period, all patients received monthly injections of 20, 40 and 60 g of the vaccine. One month after the last injection, patients who still had HBV-DNA were divided into two randomly assigned groups. While the patients in the first group and the patients who lost HBV-DNA in the first period continued to receive monthly injections of 20 g vaccine for a further 6 months, the patients in the second group received 9 MU interferon -2b (Roferon-A), three times per week using the same method as for the first group. Patients were followed up after 12 months without treatment. Response was defined as the loss of HBV-DNA and normalization of ALT.

Results: Six of the 25 patients lost HBV-DNA after 3 months. Nine of the remainder were randomly placed in the first group (vaccine-only) and 10 were placed in the second group (vaccine + interferon). End-of-treatment response was achieved, overall, 8/15 from the vaccine group and 6/10 from the combination. One patient from each group relapsed during the follow up. Overall, the sustained response (SR) rate was 46 (7/15) in the vaccine group, and 50 (5/10) in the combination group. Histological improvement was achieved in 6/7 SR with vaccine-only and all five with combination treatment, while 1/8 of failures of vaccine and 2/5 of failures of combination improved.

Conclusions: It was concluded that Genhevac-B decreases serum HBV-DNA levels in the majority of patients with CHB and sustained clearance was achieved in some patients. Combination of interferon- with Genhevac-B is effective for the vaccine failures and may increase sustained response compared to interferon- alone. However, the mechanism of action is yet to be explained. (J. Gastr. Hepatol., 17, 72-76 , 2002)