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

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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.

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Acknowledgements

Funding for the study (protocol no. NUCPT01) was provided by Glaxo Wellcome Portugal.

We gratefully acknowledge technical assistance from Dr Graça Salcedo at the Laboratório de Endocrinologia e Patologia Clínica, Porto, Portugal and the other members of the Portuguese Lamivudine Study group: J. Areias, F. Calinas, A. Porto, A. Carvalho, D. Freitas, G. Macedo, R. Noronha, J. Cotter, A. Meliço-Silvestre, R. Peixe, J. Pratas, D. Barrote, R. Teixeira, F. Augusto, I. Carrilho, F. Campante, J. Velosa, L. Carvalho, M.A. Duarte, H. Guerreiro, C. Pires, A. Silva, I. Cotrim, F. Guedes, L. Tomé, M. Marcelino, C. Gonçalves, E. Ferreira, L. Matos, P. Peixe, J. Esteves, T. Valente, C. Simões, C. Marinho, L. Jasmins, M.J. Vieira, R. Marinho, P. Matos, J. Estevens, J. Carrasquinho, P. Parada, C. Teixeira.

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Authors and Affiliations

  1. Hospital Geral de Santo António, Oporto, Portugal

    J. Areias & F. Guedes

  2. Subgrupo Hospitalar Capuchos-Desterro, Lisbon, Portugal

    F. Calinas

  3. Hospitais da Universidade de Coimbra, Coimbra, Portugal

    A. Porto, A. Carvalho, D. Freitas, A. Meliço-Silvestre & E. Ferreira

  4. Hospital de S. João, Oporto, Portugal

    G. Macedo & L. Tomé

  5. Hospital de S. Marcos, Braga, Portugal

    R. Noronha, M. Marcelino & C. Gonçalves

  6. Hospital Senhora da Oliveira, Guimarães, Portugal

    J. Cotter

  7. Hospital de Egas Moniz, Lisbon, Portugal

    R. Peixe, L. Matos & P. Peixe

  8. Hospital de S. José, Lisbon, Portugal

    J. Pratas, J. Esteves, T. Valente & C. Simões

  9. Hospital Padre Américo, Paredes, Portugal

    D. Barrote & C. Marinho

  10. Centro Hospitalar do Funchal, Funchal, Portugal

    R. Teixeira & L. Jasmins

  11. Hospital de S. Bernardo, Setúbal, Portugal

    F. Augusto

  12. Hospital Fernando da Fonseca, Amadora, Portugal

    I. Carrilho

  13. Hospital N. S. do Rosário, Barreiro, Portugal

    F. Campante & M. J. Vieira

  14. Hospital de Santa Maria, Lisbon, Portugal

    J. Velosa & R. Marinho

  15. Hospital de S. Pedro, Vila Real, Portugal

    L. Carvalho & P. Matos

  16. Hospital de Ponta Delgada, Ponta Delgada, Portugal

    M. A. Duarte

  17. Hospital Distrital de Faro, Faro, Portugal

    H. Guerreiro & J. Estevens

  18. Hospital de Santa Luzia, Viana do Castelo, Portugal

    C. Pires & J. Carrasquinho

  19. Hospital de S. Teotónio, Viseu, Portugal

    A. Silva

  20. Hospital de St. André, Leiria, Portugal

    I. Cotrim

  21. Endoclab, Oporto, Portugal

    G. Salcedo

  22. GlaxoSmithKline Portugal, Lisbon, Portugal

    P. Parada & C. Teixeira

Authors
  1. J. Areias
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  2. F. Calinas
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  3. A. Porto
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  4. A. Carvalho
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  5. D. Freitas
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  6. G. Macedo
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  7. R. Noronha
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  8. J. Cotter
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  9. A. Meliço-Silvestre
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  14. F. Augusto
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  15. I. Carrilho
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  16. F. Campante
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  18. L. Carvalho
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  23. I. Cotrim
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  24. F. Guedes
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  25. L. Tomé
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  29. L. Matos
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  30. P. Peixe
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  31. J. Esteves
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  32. T. Valente
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  33. C. Simões
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  34. C. Marinho
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  35. L. Jasmins
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  36. M. J. Vieira
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  37. R. Marinho
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  38. P. Matos
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  39. J. Estevens
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  40. J. Carrasquinho
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  41. G. Salcedo
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  42. P. Parada
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  43. C. Teixeira
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Corresponding author

Correspondence to P. Parada.

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Areias, J., Calinas, F., Porto, A. et al. One Year of Lamivudine Therapy for Portuguese Patients with Chronic Hepatitis B. Clin. Drug Investig. 23, 339–346 (2003). https://doi.org/10.2165/00044011-200323050-00004

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