Randomized, double-blind, placebo-controlled trial of oromucosal low-dose interferon following prednisone withdrawal for chronic hepatitis B infection in Filipino patients.

Objective: To evaluate the efficacy and safety of oromucosal low-dose human lymphoblastoid interferon alpha (IFN-alpha-n1 [INS]) following steroid withdrawal in Filipino patients with chronic replicative hepatitis B virus (HBV) infection.

Study Design: Randomized, double blind, placebo-controlled trial on IFN-alpha-n1 [INS], two tablets of 200 IU each or placebo, given sublingually once daily for eight months following steroid or placebo priming and withdrawal.

Results: A statistically significant clearance of hepatitis B e antigen (HBeAg) (50%) and seroconversion to positive antibody to HBeAg (anti-HBe) (42.