RESUMO
BACKGROUND/AIMS: We evaluated the effect of low molecular weight glycoproteins isolated from animal spleen (Polyerga) in ten patients with biopsy proven chronic HBV infection with ongoing replication. MATERIAL AND METHODS: Polyerga was given intramuscularly trice weekly and orally 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-treatment ALT 87.2 +/- 55.38SD, mean post-treatment ALT 62.6 +/- 41.86SD p = 0.026 t-test and Wilcoxon test p = 0.014). During the first month of Polyerga application transient increase of serum ALT was observed in 50%. In HBeAg negative patients and in patients with low pre-treatment level of HBV-DNA (below 250pg/ml) there was significant decrease of ALT by t-test (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 increasing the cytolysis shows that these drugs are active, probably by increasing the lymphokine secretion and the generation of cytotoxic T-cells. The absence of side effects, its ability to reduce viral replication and lower ALT activity even in patients with liver cirrhosis warrants further studies as a "second drug" or as a drug of choice when IFN is contraindicated.