About one third of patients with chronic hepatitis B show a sustained response when treated with interfer0n-u. Combining interferon-a with immuno- modulators might be a way to increase reaponse rate. The aim of thie study was to compare the ef6cacy of lymphoblaetaid interferons given alone with its efficacy when combined with levamisole in chronic hepatilia B. Forty-five patients with HBeAg-positive chronic hepatitia were randomly selected (with drat-Mication for ALT levels) to receive a 6-mo course of combination therapy with lymphoblastoid interferons (5 million unitidma three times per week) and levamisole (160 mg three times per week) or lympho-bLaetoid interferon at the same dose regimen and a matching placebo. Final evaluation 18 m o after randomization revealed a loes of both HBeAg and hepatitis B virus DNA with ALT normalization in 38% of patients treated with interferons alone and in 10% of patients receiving combination therapy. The higher response rate ohrved in patients treated with interferons alone was maintained after stratification for basal ALT levels (i.e., higher 146% vs. lo%] or lower 131% vs. 9%1 than three them the upper normal value). The length of time to sustained HBeAg clearance was eignificantly (p c 0.06) shorter in patients receiving monotherapy than in patients receiving combination therapy. Blindedlristological eseeeemept revealed improvement in 44% of patients treated with interferons alone compared with improvement in 8% of patients receiving combination therapy. These results indicate that levamieole has no additive effects when combined with intederons in the treatment of HBeAg-positive chronic hepatitis. (HEPATOLOGY 1992;16:1115-1119.) Clinical studies have clearly documented that patients with chronic hepatitis B and persistent HBV replication are at increased risk of progression to cirrhosis (1). Because impaired cell-mediated immunity may be an important determinant of persistent HBV infection,