A
PILOT STUDY ON THE COMBINED THERAPY WITH GM-CSF AND HEPATITIS B VACCINE IN
INTRAUTERINE INFECTED CHRONIC HEPATITIS B VIRUS CARRIER CHILDREN
Wang JS, Zhu QR, Yu H,
Zhang T
Children’s Hospital,
Fudan University, Shanghai, China
Objective: To observe
the efficacy of combined therapy with granulocyte-macrophage
colony-stimulating factor (GM-CSF) or hepatitis B immunoglobulin (HBIG)
plus recombinant hepatitis B vaccine (rHBvac) in intrauterine infected
chronic hepatitis B virus (HBV) carrier children. Methods: 27 chronic HBV infected children who were born to HBV
carrier mothers and received hepatitis B immunoprophylaxis at birth. They
were randomized into receiving combined therapy with 50µg of GM-CSF plus
10µg of rHBvac injected intramuscular at the same spot (GM-CSF group, 13
children) or 200µg HBIG and 10µg rHBvac at different muscle (HBIG group, 14
children) at a monthly four-dose schedule. HBV-DNA quantification and other
HBV serological markers were tested before and after the four-dose therapy.
Results: 12 children
in each group completed the study. Among them, 3 children in GM-CSF group
and 4 in HBIG group had elevated serum alanine transaminase (ALT) before
the trial, 2 in each group became ALT normality after the treatment. Before
the therapy, HBeAg positivity was found in nine children of GM-CSF group
and 10 of HBIG group. One in each group had a HBeAg/anti-HBe seroconversion
after the treatment. The quantity of HBV-DNA were significantly lowered
after the treatment than before (p=0.023) in GM-CSF group, and were not
significantly reduced in HBIG group. No subjects were found negative for
HBsAg after the treatment, and no serious adverse events happened in either
group. Conclusion: Combined
GM-CSF and rHBvac therapy inhibit HBV replication in carrier children who
were not protected by immunoprophylaxis.