title: Lamivudine treatment failure risks in chronic hepatitis B patients with low viral load.
abstract: OBJECTIVE
  To analyze the risk factors of lamivudine treatment failure (LTF) for the long-term use in patients with low viral load (LVL).
  
  
  METHODS
  In this multicenter study, 548 antiviral naïve noncirrhotic adult patients with LVL (for HBeAg+ patients HBV DNA <10 9 copies/ml and for HBeAg–patients HBV DNA <10 7 copies/ml) were enrolled. As a control group, 46 lamivudine-initiated patients with high viral load (HVL) were included. Primary outcome was switching to or adding on another antiviral drug as a consequence of primary nonresponse, partial response, viral breakthrough or adverse events. Secondary outcomes included LTF rates at 1, 2, 3, 4 and 5 years and LTF-related viral and host factors.
  
  
  RESULTS
  Among 594 patients, 294 had to change lamivudine at the follow-up. Primary nonresponse, partial response, viral breakthrough or adverse events frequencies were 6.8, 1.6, 64.5 and 0.1%, respectively. Five-year LTF rates were 61.3 and 84.2% in patients with LVL and HVL, respectively. Among patients with LVL, patients with <100,000 copies/ml and ≥ 100,000 copies/ ml had 54.8 and 67.3% LTF rates at the end of the 5th year, respectively. Logistic regression analysis of risk factors showed HBeAg+, hepatic activity index, HBV DNA, virological response at 6 months and duration of follow-up were independent predictors for LTF (p values were 0.001, 0.008, 0.003, 0.020 and 0.003, respectively).
  
  
  CONCLUSIONS
  Similar to patients with HVL, first-line lamivudine therapy is not efficient for long-term use in patients with LVL. LTF risk is so high even in the absence of worse predictive factors.
authors.forename: Seyfettin
authors.initials: S
authors.lastname: Koklu
authors.forename: Murat Taner
authors.initials: MT
authors.lastname: Gulsen
authors.forename: Yasar
authors.initials: Y
authors.lastname: Tuna
authors.forename: Hayretdin
authors.initials: H
authors.lastname: Koklu
authors.forename: Osman
authors.initials: O
authors.lastname: Yuksel
authors.forename: Baris
authors.initials: B
authors.lastname: Yilmaz
authors.forename: Cetin
authors.initials: C
authors.lastname: Karaca
authors.forename: Huseyin
authors.initials: H
authors.lastname: Ataseven
authors.forename: Rahmet
authors.initials: R
authors.lastname: Guner
authors.forename: Metin
authors.initials: M
authors.lastname: Kucukazman
authors.forename: Cem
authors.initials: C
authors.lastname: Kockar
authors.forename: Mehmet
authors.initials: M
authors.lastname: Demir
authors.forename: Orhan Kursat
authors.initials: OK
authors.lastname: Poyrazoglu
authors.forename: Mehmet
authors.initials: M
authors.lastname: Ibis
authors.forename: Tugrul
authors.initials: T
authors.lastname: Purnak
authors.forename: Sezgin
authors.initials: S
authors.lastname: Etgul
authors.forename: Erhan
authors.initials: E
authors.lastname: Alkan
authors.forename: Sahin
authors.initials: S
authors.lastname: Coban
authors.forename: Suut
authors.initials: S
authors.lastname: Gokturk
authors.forename: Murat
authors.initials: M
authors.lastname: Biyik
authors.forename: Ozlem
authors.initials: O
authors.lastname: Baykal
authors.forename: Omer
authors.initials: O
authors.lastname: Basar
authors.forename: Nimet
authors.initials: N
authors.lastname: Koklu
authors.forename: Gonca
authors.initials: G
authors.lastname: Tatar
authors.forename: Halis
authors.initials: H
authors.lastname: Simsek
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D024882:Drug Resistance, Viral; D005260:Female; D005500:Follow-Up Studies; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure; D019562:Viral Load
chemical_list: D000914:Antibodies, Viral; D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D019259:Lamivudine