title: Viral blips during long-term treatment with standard or double dose lamivudine in HBe antigen negative chronic hepatitis B.
abstract: OBJECTIVE
  To evaluate safety and effect on hepatitis B virus (HBV) suppression of a long-term treatment with lamivudine (LAM) at standard (100 mg/d) or double (200 mg/d) dose in chronic hepatitis B.
  
  
  METHODS
  This was a case study with matched controls (1:3) in patients with chronic hepatitis B with anti-HBe antibodies.
  
  
  RESULTS
  Twelve patients received LAM 200 mg/d and 35 LAM 100 mg/d, for a median of 28 mo. A primary response (PR; i.e. negative HBV-DNA with Amplicor assay) was achieved in 100% of LAM-200 patients and 83% of LAM-100 patients. A virological breakthrough occurred in 16.7 and 24.7%, respectively, of the PR-patients, with the appearance of typical LAM resistance mutations in all but one patient. Viremia blips (i.e. transient HBV-DNA below 80 IU/mL in patients who tested negative at Amplicor assay) were detected using a real time polymerase chain reaction (PCR) and occurred in seven out of nine patients with subsequent BT and in four out of 32 patients with end-of-study response (77.7% vs 12.5%; P = 0.001) at chi-square test). At the end of the study, 51.4% of LAM-100 patients and 83.3% of LAM-200 patients had remained stably HBV-DNA negative. Double-dose LAM was well tolerated.
  
  
  CONCLUSIONS
  Long-term treatment of anti-HBe positive chronic hepatitis B with double dose lamivudine causes a more profound and stable viral suppression as compared to conventional treatment.
authors.affiliation: Department of Infectious Diseases, Second University of Naples, Via Cotugno 1, c/o Osp. Gesu e Maria, Naples 80135, Italy.
authors.forename: Gianfranca
authors.initials: G
authors.lastname: Stornaiuolo
authors.forename: Maria
authors.initials: M
authors.lastname: Stanzione
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Brancaccio
authors.forename: Gianluca
authors.initials: G
authors.lastname: Cuomo
authors.forename: Vincenza
authors.initials: V
authors.lastname: Precone
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Di Biase
authors.forename: Francesca-M
authors.initials: FM
authors.lastname: Felaco
authors.forename: Felice
authors.initials: F
authors.lastname: Piccinino
authors.forename: Giovanni-B
authors.initials: GB
authors.lastname: Gaeta
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D000410:Alanine Transaminase