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 accord ing to their serum aspartate aminotransferase (AST) values, randomized to receive a-interferon (alfa-2b, 10 million units three times weekly ) or to be untreated controls for 16 wk. Effect of therapy on levels o f hepatitis B viral (HBV) DNA and aminotransferase activities in serum and hepatitis B e antigen (HBeAg) status was monitored. Results: Fort y-seven patients entered the trial; 11 of 25 (44%) patients receiving interferon responded by clearing HBeAg and HBV DNA within 6 months, co mpared to one of 22 (5%) controls (p < 0.05). Among those with serum A ST values < 100 U/L, 33% responded and among those with AST values > 1 00 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, wherea s none of the controls had normal ALT values or had lost HBsAg. Interf eron was stopped early in three patients (6.5%), and dosage was reduce d in a further 16 patients (35%) because of adverse effects. Predictiv e factors for a response were the pretreatment serum ALT and AST activ ities. Conclusions: Alpha-Interferon therapy (three times weekly) is r elatively well tolerated and is effective in clearing HBeAg and HBV DN A in approximately one-third of treated patients.