jects. Interferon is of less use in placebo-controlled studies in Lamivudine is a novel 2 ,3 -dideoxy cytosine analogue Chinese HBsAg carriers, possibly because the patients are that has potent inhibitory effects on hepatitis B virus immunotolerant to HBV. [5][6][7][8] However, when Chinese HBsAg replication in vitro and in vivo. We performed a singlecarriers develop elevated transaminase levels (i.e., when they blind, placebo-controlled study to assess its effectiveness are in the phase of viral clearance 9 ), their response to interand safety in Chinese hepatitis B surface antigen feron is similar to that of white patients. 8 (HBsAg) carriers. Forty-two Chinese HBsAg carriers Lamivudine is a novel 2 ,3 -dideoxy cytosine analogue that were randomized to receive placebo (6 patients) or lamihas potent inhibitory effects on HBV replication in vitro, with vudine orally in dosages of 25 mg, 100 mg, or 300 mg an IC 50 value of 5.6 mmol/L. 10,11 It is equally effective against daily (12 patients for each dosage). The drug was given the duck hepatitis B virus. 12 Studies in four chimpanzees for 4 weeks. The patients were closely monitored clinichronically infected with HBV showed that lamivudine was cally, biochemically, and serologically up to 4 weeks effective in suppression of HBV DNA in all four chimpanzees after drug treatment. All 36 patients receiving lamivuin as low a dose as 0.1 mg/kg twice daily. However, in both dine had a decrease in hepatitis B virus (HBV) DNA valducks and chimpanzees, there was a rebound of HBV DNA ues of ú90% (P õ .001 compared with placebo). Although after cessation of treatment.
mg of lamivudine was slightly less effective than 100The present study was a single-blind, placebo-controlled mg (P Å .011) and 300 mg (P Å .005), it still induced 94% study designed to investigate (1) the effectiveness of lamivusuppression of HBV DNA after the fourth week of therdine in Chinese HBsAg carriers with a 4-week course, (2) the apy. HBV DNA values returned to pretreatment levels differences in response of HBV DNA to 25 mg, 100 mg, and within 4 weeks of cessation of therapy. There was no 300 mg of lamivudine daily, and (3) and positive for HBeAg for a median of 4.5 years (range, 0.5-10.5 years). HBV DNA was tested using the Abbott genostics assay (Abbott Laboratories, Chicago, IL). The patients all had HBV DNA levels Hepatitis B virus (HBV) infection is one of the most com-of ú10 pg/mL for at least 3 months. To ensure that spontaneous mon viral infections in humans. There are an estimated 300 seroconversion was unlikely, all patients had stable serum alanine and aspartate transaminase (ALT and AST, respectively) levels of million hepatitis B surface antigen (HBsAg) carriers in the less than 2 times the upper limit of the normal range for at least 3world; approximately 75% of these are Chinese. 1 The calcumonths before entry into the study. They had not taken any other lated lifetime risk of death from hepatocellular carcinoma or investigational drugs, antiviral agents, or biological modifiers for at...