Long‐Term Lamivudine Therapy for Chronic Hepatitis B in Patients with and without Cirrhosis

Study Objective. To evaluate the effects and safety of 52‐week lamivudine therapy in Korean patients with chronic hepatitis B virus (HBV), with and without cirrhosis.Design. Long‐term retrospective studySetting. Ajoo University Medical Center, Soowon, Korea.Patients. Twenty‐seven men and two women who had received oral lamivudine 100 mg/day for 52 weeks for treatment of biopsy‐proven chronic HBV; 11 patients had cirrhosis, 18 did not.Measurements and Main Results. All 29 patients were positive for HBV DNA and hepatitis B surface antigen (HBsAg) before treatment began; 25 (86%) patients were positive for hepatitis B e antigen (HBeAg). Lamivudine therapy suppressed serum HBV DNA to undetectable levels in 26 (90%) patients within a median of 4 weeks. Serum HBV DNA of 28 patients (97%) fell significantly to undetectable levels within 12 weeks and remained undetectable in 24 (83%) patients after 52 weeks, and HBeAg had converted to negative in 10 (40%) of the 25 patients who were positive. Mean serum alanine aminotransferase (ALT) levels of the 29 patients decreased to within the normal range by 12 weeks and remained at 33–48 IU/L thereafter. Differences in responses of HBV DNA and ALT to lamivudine therapy in HBeAg‐positive and ‐negative patients were negligible (p=0.786 and p=0.225, respectively). Pretreatment HBV DNA and ALT levels had no effect on the efficacy of lamivudine (p=0.9116). Furthermore, differences in responses of HBV DNA (p=0.641), HBeAg seroconversion (p=0.386), and ALT (p=0.689) and in development of drug resistance (p=0.617) between patients with and without cirrhosis were negligible. No serious adverse effects were reported.Conclusion. Lamivudine is an effective and well‐tolerated therapeutic agent for treating chronic HBV in patients with and without cirrhosis.