Background/Aims: We evaluated the effect of Leu, molecular weight glyc
oproteins isolated from animal spleen. (Polyerga) in, ten patients wit
h biopsy proven chronic HBV infection with ongoing replication. Materi
al and Methods: Polyerga was given intramuscularly trice weekly and or
ally 3 tablets daily for 24 weeks. The effect on viral replication was
evaluated by measuring HBV-DNA and HBeAg in serum. Results: In three
out of ten, HDV-DNA became undetectable and ALT decreased (mean pre-tr
eatment ALT 87.2+/-55.38SD, mean post-treatment ALT 62.6+/-41.86SD p=0
.026 t-test and Wilcoxon. p=0.014). During the first month of Polyerga
application transient increase of serum ALT was observed in 50%. In H
BeAg negative patients and in patients with low pre-treatment level of
HBV-DNA (below 250pg/ml) there was significant decrease of ALT by t-t
est (p=0.022), Wilcoxon (p=0.028) and Sign test (p=0.041) in contrast
to those with HBV-DNA above 250pg/ml. Conclusion: The effect of increa
sing the cytolysis shows that these drugs are active, probably by incr
easing the lymphokine secretion. and the generation of cytotoxic T-cel
ls. The absence of side effects, its ability to reduce viral replicati
on and lower ALT activity even in patients with liver cirrhosis warran
ts further studies as a ''second drug'' or as a drug of choice when IF
N is contraindicated.