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A multi-center open study to determine the effect of lamivudine on HBV DNA clearance and to assess the safety of the regimen in patients with chronic hepatitis B infection.

Beata Bolewska, Jacek Adamek, Jacek Juszczyk, Andrzej Gładysz, Khalil Nazzal, Janusz Cianciara, Franciszek Król, Włodzimierz Mazur, Barbara Czajka, Katarzyna Swietek, Wiesław Kryczka, Zbigniew Gonciarz

Med Sci Monit 2002; 8(4): CR257-262

ID: 420871


BACKGROUND: Patients with on-going HBV viral replication often presentwith clinical features of active chronic hepatitis. Until the recent introduction of nucleoside analogues,interferon-alpha was the only approved drug for these patients. One of the former drugs, lamivudine,has been shown in clinical trials in the US and Asia to effectively inhibit the viral polymerase of HBV.Our study was undertaken to assess the efficacy and safety of lamivudine therapy in Polish patients withchronic hepatitis B. MATERIAL/METHODS: Forty-five patients with chronic hepatitis B (HBeAg positive,anti-e negative, HBV-DNA positive by hybridization assay) were enrolled in the study. The patients received100mg of lamivudine orally, once daily for 12 months. They returned for routine clinical and laboratorycontrol every two weeks during the first months of treatment, and later at 3-month intervals while receivinglamivudine. RESULTS: At the end of treatment, serum HBeAg was not detected in 21 patients (48.8%), andanti-HBe appeared in the serum of 19 patients. 37.2% of the patients in the study group showed sustainedsuppression of serum HBV DNA at the end of treatment. Lamivudine therapy was well tolerated, with therate of occurrence of adverse events similar to that observed in other clinical studies. CONCLUSIONS:12-month lamivudine therapy in this Polish population of patients with chronic hepatitis B induced ahigh rate of HBeAg seroconversion, accompanied by reduction of HBV-DNA and the normalization of alanineaminotransferase activities.

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