Hepatitis B—lamivudine for all and forever?: Jung MO, Jinik K, Sung WC, Efficacy and Safety of Lamivudine in Korean Patients With Chronic Hepatitis B Virus With and Without Cirrhosis. Pharmacotherapy 2002;22:1226–34

Abstract This retrospective study was designed to evaluate the safety and efficacy of long-term lamivudine therapy in Korean patients with chronic hepatitis B virus (HBV) with or without cirrhosis. Study patients were men and women who had received lamivudine 100 mg/day p.o. for 52 wk for treatment of biopsy-proven chronic HBV; 11/29 patients had cirrhosis. Patient eligibility requirements included having a diagnosis of chronic HBV, being positive for HBV by polymerase chain reaction, at least 18 yr of age, and positive for HBsAg, and having abnormally elevated ALT levels. Patients were evaluated for changes in HBV DNA and ALT concentrations, rates at which HBeAg was converted to negative, development of lamivudine resistance, and differences in the drug's effectiveness between patients with and without cirrhosis. Responses of serum HBV DNA and ALT were categorized into three groups according to degree of response to lamivudine treatment: continuous, unstable, and no response. Twenty-nine patients were evaluated in this retrospective analysis. Therapy with lamivudine suppressed serum HBV DNA to undetectable levels in 97% of patients within 12 wk and remained undetectable in 83% of patients after 52 wk. Differences in responses of HBV DNA and ALT to lamivudine therapy in HBeAg-positive and -negative patients and in the development of drug resistance between patients with and without cirrhosis were negligible. Pretreatment HBV DNA and ALT levels had no effect on the efficacy of lamivudine ( p = 0.9116). No serious adverse events were reported.