Intramuscular natural beta interferon in the treatment of chronic hepatitis B: a multicentre trial. Italian Hepatitis B Study Group.

A randomized controlled multicentre trial was undertaken to assess the effectiveness of natural IFN beta (Frone) administered by intramuscular injection to chronic hepatitis B patients. Sixty-five HBsAg and HBeAg carriers with chronic hepatitis and intrahepatic HBcAg histologically proven by immunohistochemistry were included in the study. Fifty-nine patients completed the study: 30 of them (mean age 27 years, range 14-55 years, 16M/14F) were treated with 5 Million Units (MU)/m2 of Frone three times weekly for six months and 29 (mean age 28 years, range 14-59 years, 18M/11F) were not treated. The 2 groups of patients were similar in their clinical and histological (CAH/CPH ratio 25/5 and 20/9) characteristics. In the treated patients, a significant reduction in viremia was observed starting from the 6th month of the follow-up (p < 0.01), accompanied by a significant reduction of serum aminotransferase levels (p < 0.005). At the end of therapy serum HBeAg was undetectable in 7 of 30 (23%) treated patients and in 1 of 29 (3%) controls. Six months after the end of treatment 8 of 30 (26%) treated patients and 5 of 29 (17%) controls were HBeAg negative. A significant difference (p < 0.05) was observed in the rate of anti-HBe seroconversion between the 2 groups starting from the 8th month of follow-up. Mild side effects, namely fever < 38 degrees C and asthenia were observed in 20% and 37% of treated patients. In conclusion natural beta interferon given intramuscularly is effective in HBeAg positive patients suffering from chronic hepatitis B with optimal compliance.(ABSTRACT TRUNCATED AT 250 WORDS)