title: Long-term effect of low dose recombinant interferon therapy in patients with chronic hepatitis B.
abstract: Thirty three heterosexual chronic hepatitis B virus (HBV) carriers were randomized, with stratification for disease activity, to receive intramuscular recombinant interferon alpha-2a (r-IFN) at doses of 4.5 megaunits thrice weekly for 4 months, or no treatment. During r-IFN treatment, serum HBV-DNA levels fell in all, but 2 patients. Final evaluation at 16 months after randomization revealed that the rate of complete response, i.e., loss of both HBV-DNA and HBeAg with ALT normalization was 22.2% (2 of 9 cases) in patients on interferon and 12.5% (1 of 8 cases) in untreated patients for the group with high serum alanine aminotransferase (ALT) and with piecemeal necrosis on liver biopsy on entry. The corresponding value was 25% (2 of 8 cases) in treated and 12.5% (1 of 8 cases) in untreated patients with low liver disease activity. Overall, a complete response was thus observed in 23.5% of treated patients and in 12.5% of controls. None of the patients on therapy became HBsAg negative. It is concluded that treatment of heterosexual patients with chronic hepatitis B with r-IFN in the dose regimen used here was not associated with a significant higher rate of serologic and clinical response compared to controls, independently of pretreatment biochemical and histologic activity of liver disease.
authors.affiliation: Istituto di Medicina Clinica, Università di Padova, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Fattovich
authors.forename: L
authors.initials: L
authors.lastname: Brollo
authors.forename: S
authors.initials: S
authors.lastname: Boscaro
authors.forename: P
authors.initials: P
authors.lastname: Pontisso
authors.forename: G
authors.initials: G
authors.lastname: Giustina
authors.forename: D
authors.initials: D
authors.lastname: Criscuolo
authors.forename: D
authors.initials: D
authors.lastname: Maladorno
authors.forename: A
authors.initials: A
authors.lastname: Alberti
authors.forename: G
authors.initials: G
authors.lastname: Realdi
authors.forename: A
authors.initials: A
authors.lastname: Ruol
mesh_terms: D000293:Adolescent; D000328:Adult; D001706:Biopsy; D002353:Carrier State / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D006521:Hepatitis, Chronic / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D013997:Time Factors
chemical_list: D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins