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 study.
SETTING: 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.