Original Research Article

Clinical Drug Investigation

, Volume 23, Issue 5, pp 339-346

One Year of Lamivudine Therapy for Portuguese Patients with Chronic Hepatitis B

  • J. AreiasAffiliated withHospital Geral de Santo António
  • , F. CalinasAffiliated withSubgrupo Hospitalar Capuchos-Desterro
  • , A. PortoAffiliated withHospitais da Universidade de Coimbra
  • , A. CarvalhoAffiliated withHospitais da Universidade de Coimbra
  • , D. FreitasAffiliated withHospitais da Universidade de Coimbra
  • , G. MacedoAffiliated withHospital de S. João
  • , R. NoronhaAffiliated withHospital de S. Marcos
  • , J. CotterAffiliated withHospital Senhora da Oliveira
  • , A. Meliço-SilvestreAffiliated withHospitais da Universidade de Coimbra
    • , R. PeixeAffiliated withHospital de Egas Moniz
    • , J. PratasAffiliated withHospital de S. José
    • , D. BarroteAffiliated withHospital Padre Américo
    • , R. TeixeiraAffiliated withHospital Geral de Santo AntónioCentro Hospitalar do Funchal
    • , F. AugustoAffiliated withHospital Geral de Santo AntónioHospital de S. Bernardo
    • , I. CarrilhoAffiliated withHospital Geral de Santo AntónioHospital Fernando da Fonseca
    • , F. CampanteAffiliated withHospital Geral de Santo AntónioHospital N. S. do Rosário
    • , J. VelosaAffiliated withHospital Geral de Santo AntónioHospital de Santa Maria
    • , L. CarvalhoAffiliated withHospital Geral de Santo AntónioHospital de S. Pedro
    • , M. A. DuarteAffiliated withHospital Geral de Santo AntónioHospital de Ponta Delgada
    • , H. GuerreiroAffiliated withHospital Geral de Santo AntónioHospital Distrital de Faro
    • , C. PiresAffiliated withHospital Geral de Santo AntónioHospital de Santa Luzia
    • , A. SilvaAffiliated withHospital Geral de Santo AntónioHospital de S. Teotónio
    • , I. CotrimAffiliated withSubgrupo Hospitalar Capuchos-DesterroHospital de St. André
    • , F. GuedesAffiliated withHospital Geral de Santo António
    • , L. ToméAffiliated withHospital de S. João
    • , M. MarcelinoAffiliated withHospital de S. Marcos
    • , C. GonçalvesAffiliated withHospital de S. Marcos
    • , E. FerreiraAffiliated withHospitais da Universidade de Coimbra
    • , L. MatosAffiliated withHospital de Egas Moniz
    • , P. PeixeAffiliated withHospital de Egas Moniz
    • , J. EstevesAffiliated withHospital de S. José
    • , T. ValenteAffiliated withHospital de S. José
    • , C. SimõesAffiliated withHospital de S. José
    • , C. MarinhoAffiliated withHospital Padre Américo
    • , L. JasminsAffiliated withHospital Geral de Santo AntónioCentro Hospitalar do Funchal
    • , M. J. VieiraAffiliated withHospital Geral de Santo AntónioHospital N. S. do Rosário
    • , R. MarinhoAffiliated withHospital Geral de Santo AntónioHospital de Santa Maria
    • , P. MatosAffiliated withHospital Geral de Santo AntónioHospital de S. Pedro
    • , J. EstevensAffiliated withHospital Geral de Santo AntónioHospital Distrital de Faro
    • , J. CarrasquinhoAffiliated withHospital Geral de Santo AntónioHospital de Santa Luzia
    • , G. SalcedoAffiliated withSubgrupo Hospitalar Capuchos-DesterroEndoclab
    • , P. ParadaAffiliated withSubgrupo Hospitalar Capuchos-DesterroGlaxoSmithKline Portugal Email author 
    • , C. TeixeiraAffiliated withSubgrupo Hospitalar Capuchos-DesterroGlaxoSmithKline Portugal

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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.

Patients: 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.

Conclusion: 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.