A randomized, controlled trial of recombinant alpha-interferon therapy for chronic hepatitis B.

OBJECTIVES

To evaluate the effect of recombinant alpha-interferon in chronic hepatitis B.

METHODS

Patients were stratified at entry according to their serum aspartate aminotransferase (AST) values, randomized to receive alpha-interferon (alfa-2b, 10 million units three times weekly) or to be untreated controls for 16 wk. Effect of therapy on levels of hepatitis B viral (HBV) DNA and aminotransferase activities in serum and hepatitis B e antigen (HBeAg) status was monitored.

RESULTS

Forty-seven patients entered the trial; 11 of 25 (44%) patients receiving interferon responded by clearing HBeAg and HBV DNA within 6 months, compared to one of 22 (5%) controls (p < 0.05). Among those with serum AST values < 100 U/L, 33% responded and among those with AST values > 100 U/L, 60% responded. Within the 6-month study period, 36% of treated patients had normal serum alanine aminotransferase (ALT) values, and 16% had cleared hepatitis B surface antigen (HBsAg) from serum, whereas none of the controls had normal ALT values or had lost HBsAg. Interferon was stopped early in three patients (6.5%), and dosage was reduced in a further 16 patients (35%) because of adverse effects. Predictive factors for a response were the pretreatment serum ALT and AST activities.

CONCLUSIONS

alpha-Interferon therapy (three times weekly) is relatively well tolerated and is effective in clearing HBeAg and HBV DNA in approximately one-third of treated patients.