title: The French experience of treatment of chronic type D hepatitis with a 12-month course of interferon alpha-2B. Results of a randomized controlled trial.
abstract: Hepatitis due to hepatitis delta virus (HDV) infection is generally associated with severe histological abnormalities and rapid progression of the disease. To assess the efficacy of recombinant interferon-a2b in treatment of chronic delta hepatitis, 22 patients were entered into a randomized controlled trial: 11 received interferon-a2b subcutaneously three times weekly for 12 months (5 MU/m2 for 4 months and then 3 MU/m2 for a further 8 months) and 11 were untreated. All patients were followed up for 6 months after the completion of therapy. Nine treated patients completed the trial: one was withdrawn with hyperthyroidism and one committed suicide. Serum ALT levels were normalized or significantly reduced, always within 3 months of initiating treatment, and remained so in 73% of treated patients at the 4th month and in 54.5% at the 12th month, compared with 18% and 18%, respectively, in the untreated group. Moreover, in seven of nine treated patients, interferon was associated with the clearance of serum HDV-RNA, associated with amelioration of the histological picture, whereas this occurred in only four of 11 untreated patients. On cessation of therapy, all patients but one experienced a biological and/or virological relapse over the 6-month follow up. In conclusion, our data confirm that HDV is sensitive to inhibition by interferon-a2b, although the schedule used did not achieve permanent control of the disease. The adverse effects of interferon require consideration; in particular, care will be needed to avoid serious psychiatric side effects.
authors.affiliation: Service d'Hépato-Gastroentérologie, Hôpital de la Croix-Rousse, Lyon, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Gaudin
authors.forename: P
authors.initials: P
authors.lastname: Faure
authors.forename: H
authors.initials: H
authors.lastname: Godinot
authors.forename: F
authors.initials: F
authors.lastname: Gerard
authors.forename: C
authors.initials: C
authors.lastname: Trepo
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D003699:Hepatitis D / Q000175:diagnosis / Q000473:pathology / Q000628:therapy*; D003698:Hepatitis Delta Virus / Q000187:drug effects; D006521:Hepatitis, Chronic / Q000175:diagnosis / Q000473:pathology / Q000628:therapy; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D014779:Virus Replication / Q000187:drug effects
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins