Abstract :
Background: Vaccination against hepatitis B infection is recommended for patients with chronic liver
disease who are seronegative for hepatitis B infection. However, the response rate is lower, compared with the
general population. Currently, there is inconclusive data to establish the best vaccine schedule for this group of
patients.
Objectives & Methods: We performed a prospective study in patients with chronic liver disease to
evaluate the immune response rate at one month after completion of conventional hepatitis B vaccination (3 doses
of recombinant hepatitis B vaccination (20 μg) at 0, 1, 6 months). In patients who could not achieve immune
response from conventional regimen was added one additional double-dose. Factors related to immune response
were analyzed.
Fifty-five patients were enrolled although 35 patients had completed conventional vaccination. There
were 23 males and 12 females, mean age 56.2±10.5 years and 80% were Child Pugh class A. The causes of chronic
liver disease were NASH (25.7%), alcoholic hepatitis (17%), chronic hepatitis C (23%), and liver cirrhosis (43%).
Results: A total of 35 vaccinated patients were studied. The 48% and 54% exhibited an immune response
after conventional regimen and additional double-dose regimen respectively. The overall immune response
increased from 48.6-80%. Higher HBsAb levels were achieved from additional dose of vaccine, the median HBsAb
level was 112.4 mIU/mL (range 13.8-833) after the conventional regimen and 639.13 mIU/mL (range 12-833) after
the four-dose regimen.
From univariate analysis, the variables associated with a higher immune response for the conventional
regimen included non-cirrhosis (p=0.041), albumin > 3.5 g/dL (p=0.002), PT<12 seconds (p=0.027), A/G ratio
greater than 1 (p=0.026), MELD < 8 (p=0.029), Child Pugh score ≥ 5 (p=0.015), and platelet >120,000/mL (p=0.049).
Patients with Child Pugh score upto 6 and patients with anemia (Hb >11.5) showed an improved response from the
additional dose (p=0.041, p=0.04, respectively). However, no significant differences were identified by multivariate
analysis.
Conclusions: Patients with chronic liver disease and cirrhosis achieved a lower rate of immune response
from conventional regimen of hepatitis B vaccination. However, an additional dose could improve the
immune response rate and increase the HBsAb level. The immune response was better in patients at early stages of
liver disease.
|