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

Patients with on-going HBV viral replication often present with 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 with chronic hepatitis B. 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 received 100mg of lamivudine orally, once daily for 12 months. They returned for routine clinical and laboratory control every two weeks during the first months of treatment, and later at 3-month intervals while receiving lamivudine. At the end of treatment, serum HBeAg was not detected in 21 patients (48.8%), and anti-HBe appeared in the serum of 19 patients. 37.2% of the patients in the study group showed sustained suppression of serum HBV DNA at the end of treatment. Lamivudine therapy was well tolerated, with the rate of occurrence of adverse events similar to that observed in other clinical studies. 12-month lamivudine therapy in this Polish population of patients with chronic hepatitis B induced a high rate of HBeAg seroconversion, accompanied by reduction of HBV-DNA and the normalization of alanine aminotransferase activities.