title: One year of Lamivudine therapy for portuguese patients with chronic hepatitis B.
abstract: OBJECTIVE
  To assess the efficacy of lamivudine treatment on hepatitis B e antigen (HBeAg) and/or hepatitis B surface antigen (HBsAg) seroconversion, on other virological and serological markers of response including hepatitis B virus (HBV) DNA and serum aminotransferases, and the safety of lamivudine treatment in hepatitis B patients.
  
  
  METHODS
  This phase III open-label study evaluated the virological and biochemical response to lamivudine in 70 Portuguese patients with HBeAg positive chronic hepatitis B. Patients were treated with lamivudine 100mg once daily for 12 months.
  
  
  METHODS
  Antiviral activity was assessed by measuring alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels at all protocol visits, and hepatitis B serology and HBV DNA were performed at baseline and at month 12 visits. Evaluation of safety and tolerance was based on clinical adverse events and laboratory analyses.
  
  
  RESULTS
  The primary endpoint was virological response at month 12, defined as loss of detectable HBeAg from serum with a reduction of HBV DNA to undetectable levels, and this was observed in 19/69 (27.5%) of patients. Almost half of the patients were HBV DNA negative by this time. Mean ALT values decreased steadily during treatment and by 12 months 61% of patients had values within the normal range. HBeAg seroconversion (HBeAg negative, HBeAb positive) was achieved in 27.9% of patients by 12 months, although all patients remained HBsAg positive.
  
  
  CONCLUSIONS
  Lamivudine was well tolerated and the incidence of adverse events was similar to those reported in previous studies. Lamivudine treatment resulted in virological and biochemical improvements in HBeAg positive chronic hepatitis B patients, with HBeAg seroconversion in one-third of patients.
authors.affiliation: Hospital Geral de Santo António, Oporto, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Areias
authors.forename: F
authors.initials: F
authors.lastname: Calinas
authors.forename: A
authors.initials: A
authors.lastname: Porto
authors.forename: A
authors.initials: A
authors.lastname: Carvalho
authors.forename: D
authors.initials: D
authors.lastname: Freitas
authors.forename: G
authors.initials: G
authors.lastname: Macedo
authors.forename: R
authors.initials: R
authors.lastname: Noronha
authors.forename: J
authors.initials: J
authors.lastname: Cotter
authors.forename: A
authors.initials: A
authors.lastname: Meliço-Silvestre
authors.forename: R
authors.initials: R
authors.lastname: Peixe
authors.forename: J
authors.initials: J
authors.lastname: Pratas
authors.forename: D
authors.initials: D
authors.lastname: Barrote
authors.forename: R
authors.initials: R
authors.lastname: Teixeira
authors.forename: F
authors.initials: F
authors.lastname: Augusto
authors.forename: I
authors.initials: I
authors.lastname: Carrilho
authors.forename: F
authors.initials: F
authors.lastname: Campante
authors.forename: J
authors.initials: J
authors.lastname: Velosa
authors.forename: L
authors.initials: L
authors.lastname: Carvalho
authors.forename: M A
authors.initials: MA
authors.lastname: Duarte
authors.forename: H
authors.initials: H
authors.lastname: Guerreiro
authors.forename: C
authors.initials: C
authors.lastname: Pires
authors.forename: A
authors.initials: A
authors.lastname: Silva
authors.forename: I
authors.initials: I
authors.lastname: Cotrim
authors.forename: F
authors.initials: F
authors.lastname: Guedes
authors.forename: L
authors.initials: L
authors.lastname: Tomé
authors.forename: M
authors.initials: M
authors.lastname: Marcelino
authors.forename: C
authors.initials: C
authors.lastname: Gonçalves
authors.forename: E
authors.initials: E
authors.lastname: Ferreira
authors.forename: L
authors.initials: L
authors.lastname: Matos
authors.forename: P
authors.initials: P
authors.lastname: Peixe
authors.forename: J
authors.initials: J
authors.lastname: Esteves
authors.forename: T
authors.initials: T
authors.lastname: Valente
authors.forename: C
authors.initials: C
authors.lastname: Simões
authors.forename: C
authors.initials: C
authors.lastname: Marinho
authors.forename: L
authors.initials: L
authors.lastname: Jasmins
authors.forename: M J
authors.initials: MJ
authors.lastname: Vieira
authors.forename: R
authors.initials: R
authors.lastname: Marinho
authors.forename: P
authors.initials: P
authors.lastname: Matos
authors.forename: J
authors.initials: J
authors.lastname: Estevens
authors.forename: J
authors.initials: J
authors.lastname: Carrasquinho
authors.forename: G
authors.initials: G
authors.lastname: Salcedo
authors.forename: P
authors.initials: P
authors.lastname: Parada
authors.forename: C
authors.initials: C
authors.lastname: Teixeira