Four years of treatment with lamivudine: Clinical and virological evaluations in HBe antigen-negative chronic hepatitis B

S. Gaia, A. Marzano, A. Smedile, V. Barbon, M. L. Abate, A. Olivero, M. Lagget, S. Paganin, M. Fadda, G. Niro, M. Rizzetto

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Abstract

Aim: To evaluate the clinical and virological impact of the prolonged use of lamivudine in 94 patients with HBe antigen-negative chronic hepatitis B. Methods: Initial virological and biochemical responses were obtained in 84 (89%) and in 83 (88%) patients respectively. Results: The virological response peaked within the first 12 months, but diminished to 39% at 48 months because of drug resistance. Overall a virological breakthrough developed in 44 patients (52.4%). After virological breakthrough, the actuarial probability of maintaining biochemical remission diminished to 15% at 24 months and 0% at 29 months. There was no response in 10.6%. Polymerase gene mutations were observed in 82.5% of virological breakthroughs but also in 75% of the non-responders. Overall 7.4% of patients developed a hepatocellular carcinoma. Conclusion: Almost 90% of patients responded initially to lamivudine but the emergence of drug resistance progressively reduced the rate of virological remission to 39% at the fourth year of therapy. YMDD mutants explained the 75% of lamivudine resistances and were also selected very early in non-responders. Although the biochemical response is invariably lost within 29 months of the YMDD mutant's duration, the clinical outcome was benign despite severe postvirological breakthrough hepatitic flares in about 12% of cases.

Original languageEnglish
Pages (from-to)281-287
Number of pages7
JournalAlimentary Pharmacology and Therapeutics
Volume20
Issue number3
DOIs
Publication statusPublished - Aug 1 2004

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ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Gaia, S., Marzano, A., Smedile, A., Barbon, V., Abate, M. L., Olivero, A., Lagget, M., Paganin, S., Fadda, M., Niro, G., & Rizzetto, M. (2004). Four years of treatment with lamivudine: Clinical and virological evaluations in HBe antigen-negative chronic hepatitis B. Alimentary Pharmacology and Therapeutics, 20(3), 281-287. https://doi.org/10.1111/j.1365-2036.2004.02073.x