Randomized, double-blind, placebo-controlled trial of oromucosal low-dose

liver411

Original Report

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

Thelma E. Tupasi,(1) Vilma M. Co,(1) Ma. Socorro M. Clarin,(1) Evelyn T.
Alesna,(1) Ella Mae S. Divinagracia(1) and Nellie V. Mangubat(1)

Objective: To evaluate the efficacy and safety of oromucosal low-dose human
lymphoblastoid interferon alpha (IFN-a-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-a-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)
(42.9%) was noted in those given IFN-a-n1 [INS] compared with the placebo
group. Clearance of serum HBV-DNA was not significantly different and none
cleared HBsAg in both groups. More patients (57%) had normalization of ALT
on IFN-a-n1 [INS] compared with controls (31.3%). Oromucosal IFN-a-n1 [INS]
was devoid of any evidence of toxicity.

Conclusion: This study conducted on a limited number of patients
demonstrates the potential efficacy of oromucosal IFN-a-n1 [INS] in chronic
HBV infection with therapeutic benefit equal to parenterally administered
interferon alpha (IFNa) but without the side effects of myelosuppresion.
Owing to the small population studied, we are unable to extrapolate these
findings to the general population of patients with chronic HBV infection. A
large-scale study is needed to confirm these findings.

Int J Infect Dis 2002; 6: #-41