In a multicentre trial, 82 patients known to be
hepatitis B e antigen and hepatitis B virus
DNA positive for at least 1 year, with elevated serum
alanine aminotransferase levels and chronic liver lesions on biopsy, were randomized to receive either recombinant
interferon alfa-2a at a dose of 4.5 million units thrice weekly for 4 months or no treatment. At the end of
therapy,
viral DNA clearance and
aminotransferase normalization were significantly (p less than 0.05) more frequent in treated patients than in controls. After 16 months' follow up, the difference was still significant for
hepatitis B e antigen clearance and
transaminase normalization. Hepatitis B virus
DNA reactivation was observed during follow up in 43% of treated patients and 50% of controls. Improvements in liver
inflammation were observed in patients on
interferon. High pre-treatment serum
aminotransferase levels, female sex and a low score for
fibrosis in the initial biopsy were predictive factors significantly (p less than 0.05) associated with termination of hepatitis B virus replication in treated cases. These results indicate that
interferon is effective in inducing clearance of HBV from serum and improvement of biochemical and histological parameters of
liver disease. However, a more prolonged regimen of
therapy may be required to obtain stable suppression of hepatitis B virus replication.