title: Lamivudine monotherapy and lamivudine plus interferon alpha combination therapy in HBeAg negative chronic hepatitis B not responding to previous interferon alpha monotherapy.
abstract: OBJECTIVE
  To investigate the efficacy of the combined therapy of lamivudine (LAM) plus alpha interferon (IFN) and LAM monotherapy in HBeAg negative chronic hepatitis B (CHB) patients who were unresponsive to previous IFN monotherapy, and the incidence of YMDD mutations.
  
  
  METHODS
  Forty-five HBeAg negative patients were enrolled in this study. 24 of these were treated with LAM (100 mg/day, PO, for 24 months) alone (group 1) and 21 with combined therapy (IFN-alpha-2b, 10 MU, tiw, SC, for 6 months plus LAM 100 mg/day, PO, for 24 months) (group 2). Normal alanine aminotransferase values and negativity of HBV DNA (molecular hybridization; Digene, USA) were accepted as treatment response. YMDD variants were analyzed at the end of treatment or when clinical breakthrough was observed (Inno-Lipa Innogenetic kit, Belgium).
  
  
  RESULTS
  End of follow-up response rate was 29.2%, by ITT in group 1, 19% in group 2 (p > 0.05). Histological activity index was statistically decreased by LAM monotherapy as compared to combination therapy. YMDD mutation rates were 59% in group 1, 62.5% in group 2 (p > 0.05).
  
  
  CONCLUSIONS
  Additional IFN-alpha therapy to LAM in HBeAg negative CHB not responding to previous IFN-alpha monotherapy does not increase the response rate compared to LAM monotherapy and does not also decrease the incidence of YMDD mutations.
authors.affiliation: (1) Department of Gastroenterohepatology, Istanbul University, Istanbul Medical Faculty. filizakyuz@hotmail.com
authors.forename: Filiz
authors.initials: F
authors.lastname: Akyuz
authors.forename: Sabahattin
authors.initials: S
authors.lastname: Kaymakoglu
authors.forename: Kadir
authors.initials: K
authors.lastname: Demir
authors.forename: Nevzat
authors.initials: N
authors.lastname: Aksoy
authors.forename: Cetin
authors.initials: C
authors.lastname: Karaca
authors.forename: Ahmet
authors.initials: A
authors.lastname: Danalioglu
authors.forename: Derya
authors.initials: D
authors.lastname: Onel
authors.forename: Selim
authors.initials: S
authors.lastname: Badur
authors.forename: Fatih
authors.initials: F
authors.lastname: Besisik
authors.forename: Yilmaz
authors.initials: Y
authors.lastname: Cakaloglu
authors.forename: Atilla
authors.initials: A
authors.lastname: Okten
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011994:Recombinant Proteins
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D019259:Lamivudine