title: Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta.
abstract: Therapy of chronic hepatitis delta with standard interferon therapy has met with limited efficacy. This study was designed to examine the efficacy and safety of peginterferon with or without ribavirin. Thirty-eight serum hepatitis B surface antigen- and HDV RNA-positive patients with alanine aminotransferase (ALT) more than 1.5 times the upper normal limit received peginterferon alpha-2b (1.5 microg/kg) alone as monotherapy (n=16) or in combination with ribavirin (n=22), for 48 weeks. Thereafter, all the patients were maintained on peginterferon for 24 weeks and followed for 24 weeks off therapy. The primary end point studied was the virological and biochemical response at the end of follow-up. HDV RNA was determined by single or nested polymerase chain reaction assays. Twenty-seven patients (71%), 11 receiving monotherapy and 16 receiving the combination treatment, completed the follow-up. At the end of treatment, a virological response was observed in 3 of the patients treated with peginterferon (19%) and in 2 of the patients treated with combination therapy (9%), and a biochemical response was observed in 6 (37.5%) and 9 patients (41%), respectively. In nonresponders, ALT diminished from a mean of 174+/-53 to 86+/-41 IU/L. At the end of follow-up, serum HDV RNA was negative in 8 patients (21%), and a biochemical response was detected in 10 patients (26%). Treatment was discontinued in 25% of the patients, and dosing was modified in 58%. In conclusion, a prolonged course of peginterferon alpha-2b resulted in clearance of serum HDV RNA and ALT normalization in a fifth of patients with chronic hepatitis D, while ribavirin had no effect on the viral clearance rate. Overall tolerance of therapy was poor.
authors.affiliation: Gastroenterology CSS Hospital, S.Giovanni Rotondo, and Gastroenterology Molinette Hospital and Unversity, Turin, Italy. g.niro@operapadrepio.it
authors.forename: Grazia Anna
authors.initials: GA
authors.lastname: Niro
authors.forename: Alessia
authors.initials: A
authors.lastname: Ciancio
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: Gaeta
authors.forename: Antonina
authors.initials: A
authors.lastname: Smedile
authors.forename: Aldo
authors.initials: A
authors.lastname: Marrone
authors.forename: Antonella
authors.initials: A
authors.lastname: Olivero
authors.forename: Maria
authors.initials: M
authors.lastname: Stanzione
authors.forename: Ezio
authors.initials: E
authors.lastname: David
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Brancaccio
authors.forename: Rosanna
authors.initials: R
authors.lastname: Fontana
authors.forename: Francesco
authors.initials: F
authors.lastname: Perri
authors.forename: Angelo
authors.initials: A
authors.lastname: Andriulli
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D001706:Biopsy; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019701:Hepatitis D, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D003698:Hepatitis Delta Virus / Q000187:drug effects / Q000235:genetics; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000187:drug effects / Q000235:genetics; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b