title: Lamivudine/interferon combination therapy in anti-HBe positive chronic hepatitis B patients: a controlled pilot study.
abstract: OBJECTIVE
  In this study, lamivudine-interferon (LAM/IFN) combination therapy was compared to LAM monotherapy to verify if the combination treatment might improve efficacy and reduce the emergence of LAM-resistant mutants.
  
  
  METHODS
  Fifty patients with anti-HBe-positive chronic hepatitis B were treated for 12 months with LAM at 100mg/day (26 pts) or with IFN at 5MU t.i.w.+LAM 100mg/day (24 pts). Serum ALT, HBV DNA and IgM anti-HBc were monitored during treatment and a 6-month follow-up. The polymerase gene was amplified by PCR and the region coding for YMDD motif was directly sequenced.
  
  
  RESULTS
  All patients normalized ALT and cleared HBV DNA during treatment. The response was maintained until the end of therapy in the LAM/IFN group, while in 5/26 initial responders treated with LAM alone, a virological and biochemical breakthrough was observed after 6-10 months, and selection for YMDD variants resulted. After therapy discontinuation, most patients relapsed; the response rate after 6 months was 17% in the LAM/IFN group and 19% in the LAM group.
  
  
  CONCLUSIONS
  In anti-HBe-positive chronic hepatitis B, a 12-month course of LAM/IFN combination therapy is as beneficial as LAM monotherapy, however, the combination regimen appeared to prevent or delay the emergence of YMDD variants.
authors.affiliation: Department of Internal Medicine, Immunology and Infectious Diseases, University of Bari, Bari, Italy. t.santantonio@clininf.uniba.it
authors.forename: Teresa
authors.initials: T
authors.lastname: Santantonio
authors.forename: Grazia Anna
authors.initials: GA
authors.lastname: Niro
authors.forename: Emanuele
authors.initials: E
authors.lastname: Sinisi
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Leandro
authors.forename: Maria
authors.initials: M
authors.lastname: Insalata
authors.forename: Angela
authors.initials: A
authors.lastname: Guastadisegni
authors.forename: Domenico
authors.initials: D
authors.lastname: Facciorusso
authors.forename: Eleonora
authors.initials: E
authors.lastname: Gravinese
authors.forename: Angelo
authors.initials: A
authors.lastname: Andriulli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pastore
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D006511:Hepatitis B Antigens / Q000032:analysis; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000008:administration & dosage*; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D006511:Hepatitis B Antigens; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D007372:Interferons