efficacy and safety of interferon alfa for treatment of chronic hepatitis B infected subjects in Iran

ABSTRACT

This preliminary study was designed to evaluate the effects of Heberon Alfa for the treatment of chronic hepatitis B infected subjects in Iran. A single center, open label, single treatment prospective study of Interferon Alfa [Heberon Alfa], 5 million units every other day for a period of 4 months, was performed between 1996 to 1998. A total number of 30 patients with histologically documented chronic hepatitis and positive serum HBsAg were included in the study. Serum ALT of all patients was greater than 1.5 times normal before start of therapy. Effect of therapy on aminotransferase activity and HBsAg, HBeAg seroconversion was monitored and all the patients underwent a second liver biopsy at the end of the study period. Mean age of patients was 35.5 +/- 12 [17 to 60 years old] and 73% of patients were mate. Most patients experienced adverse effects, but none warranted stopping the treatment. No serious or unexpected adverse event was reported during the study period. Thrombocytopenia was recorded in 2 patients. Liver biopsy showed a decrease in hepatic inflammation in 53.5% of patients, no change in 36.7% and increase in hepatic inflammation in 10% of patients after the treatment. Serum ALT returned to normal in 18 patients [60%], decreased in 7 patients [23.3%] and didn't change in 5 patients [16.7%]. There was a strong correlation between serum ALT normalization and histological improvement. HBsAg became negative in 5 patients [16.6%]. 10 patients had positive HBeAg prior to therapy, which became negative in 4 of them [40%] by the end of the study. The current study confirms the result of other clinical trials and indicates that Heberon Alfa is a safe and effective drug for the treatment of chronic hepatitis B infected subjects with histologically documented chronic hepatitis