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.


METHODS
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) (42.9%) was noted in those given IFN-alpha-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-alpha-n1 [INS] compared with controls (31.3%). Oromucosal IFN-alpha-n1 [INS] was devoid of any evidence of toxicity.


CONCLUSIONS
This study conducted on a limited number of patients demonstrates the potential efficacy of oromucosal IFN-alpha-n1 [INS] in chronic HBV infection with therapeutic benefit equal to parenterally administered interferon alpha (IFNalpha) 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.
Tupasi
Thelma E
TE
Tropical Disease Foundation, Makati Medical Center, Makati City, Philippines. tdf@info.com.ph
Co
Vilma M
VM
Clarin
Ma Socorro M
MS
Alesna
Evelyn T
ET
Divinagracia
Ella Mae S
EM
Mangubat
Nellie V
NV
D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D009061:Mouth Mucosa; D010679:Philippines; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D000998:Antiviral Agents; D005938:Glucocorticoids; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011241:Prednisone