Response to an Experimental HBV Vaccine Permits Withdrawal
of HBIG Prophylaxis in HBV-infected Liver Graft Recipients
Strategies using lamivudine
(Epivir-HBV) and hepatitis
B immunoglobulins (HBIG)
for prevention of hepatitis B virus (HBV) reinfection after
liver
transplantation (LT) are expensive since life-long treatment is needed.
Researchers
in Belgium evaluated the possibility of obtain protective
hepatitis
B surface antigen (HBsAg) antibody (anti-HBs) titers after LT and to discontinue
HBIG prophylaxis after a reinforced course of vaccination
against HBV using an experimental adjuvant HBsAg / AS04 vaccine (GlaxoSmithKline
Biologicals [GSK], Rixensart, Belgium) in patients transplanted
for hepatitis B.
Fifteen
LT patients on stable low-level immunosuppression were vaccinated
with a double dose of the vaccine at 0, 1, 2, 6, and 12
months: 5 patients were transplanted for non viral diseases
and 10 patients were transplanted for HBV on HBIG monotherapy.
HBIg
were continued during baseline vaccination (0, 1, and 2
months) and when anti-HBs titers determined every 6 weeks
dropped below 150 IU/L. Overall follow-up was 18 months.
Sustained
long-term response to vaccination was defined as anti-HBs
titers >500 IU/L without further need for HBIg administration
during a follow-up period of at least 12 months.
Results
· Overall
sustained response to vaccination was 53% (8 / 15 patients);
· 80%
(4 / 5 patients) in the non viral disease group and 40%
(4 / 10 patients) in the HBV group (2 /2 fulminant and 2/8
chronically infected patients) developed a sustained long-term
response and were completely free of HBIg at the end of
the 18-month follow-up.
· No
HBV recurrence, rejection episodes, or side effects occurred
during the follow-up.
In
conclusion, the authors write, “Protective anti-HBs titers
were obtained in a substantial number of LT patients following
a reinforced course of HBV vaccination with vaccines containing
new immunostimulating adjuvants. Vaccination seems well
tolerated and safe and allows long-term discontinuation
of HBIG.”
Department of Gastroenterology, St. Luc University
Hospital, Brussels, Belgium.
10/03/05
Reference
P Starkel and others. Response to an experimental HBV vaccine
permits withdrawal of HBIg prophylaxis in fulminant and
selected chronic HBV-infected liver graft recipients. Liver
Transplantation 11(10):1228-1234. October 2005.
