Loss and Seroconversion of Hepatitis B Surface Antigen after Vaccine Therapy in Chronic Hepatitis B Patients Treated with Nucleoside/Nucleotide Analogues
Stefano Brillanti, Liboria Laterza, Paolo Cecinato, Franco Bazzoli
Division of Gastroenterology, University of Bologna, Bologna, Italy
HBsAg to anti-HBs seroconversion represents the definitive virological end-point of treatment in patients with chronic HBV infection. Unfortunately this event rarely occurs even after several years of therapy. AIM of this pilot study was to assess whether vaccine immunotherapy may induce HBsAg loss and anti-HBs seroconversion in chronic hepatitis B patients treated with nucleoside/nucleotide analogues (NA).
Methods: Among 113 HBeAg-negative adult patients on NA monotherapy for longer than 12 months, all with HBV DNA levels > 2000 IU/mL and HBsAg levels > 1500 IU/mL before starting treatment, 10 consecutive patients with normal ALT values, undetectable HBV DNA levels (< 25 IU/mL) and HBsAg levels < 250 IU/mL were selected. Five patients were randomly assigned to recive HBV vaccine therapy: 3 doses, one month apart, of 40 mcg yeast-derived recombinant hepatitis B vaccine (HBVAXPro, Sanofi Pasteur MSD), while 5 patients continued NA therapy without vaccination. HBsAg and HBV DNA status was assessed 6 months afterwards.
Results: Characteristics of the 10 patients: HBV genotype= A/D: 2/8. NA therapy: Lamivudine (2), Adefovir (4), Telbivudine (4), median treatment duration: 19 months, median HBsAg level: 48.3 IU/mL. Treatment duration and HBsAg levels were comparable between the two groups. Six months after the third dose of HBV vaccine, HBsAg loss occurred in 2/5 patients and HBsAg to Anti-HBs seroconversion in 1/5 patient. No HBsAg loss and/or seroconversion was observed in the 5 control patients. HBV DNA remained undetectable in 9/10 patients.
Conclusions: This pilot, proof-of-concept study indicates that in HBeAg-negative patients with chronic HBV infection, who experience a complete virological response and a significant decline in HBsAg levels during NA treatment, HBV vaccine therapy may enhance HBsAg loss and anti-HBs seroconversion.
Dr. Stefano Brillanti, University of Bologna , Bologna , Italy
Assigned in sessions:
07.06.2013, 08:30-17:30, PT-4, HEP B Clinical, Exhibition Hall