Hepatology. 1997 Jan;25(1):241-4. Unique Identifier : AIDSLINE
Lamivudine is a novel 2',3'-dideoxy cytosine analogue that has potent
inhibitory effects on hepatitis B virus replication in vitro and in
vivo. We performed a single-blind, placebo-controlled study to assess
its effectiveness and safety in Chinese hepatitis B surface antigen
(HBsAg) carriers. Forty-two Chinese HBsAg carriers were randomized to
receive placebo (6 patients) or lamivudine orally in dosages of 25 mg,
100 mg, or 300 mg daily (12 patients for each dosage). The drug was
given for 4 weeks. The patients were closely monitored clinically,
biochemically, and serologically up to 4 weeks after drug treatment. All
36 patients receiving lamivudine had a decrease in hepatitis B virus
(HBV) DNA values of >90% (P < .001 compared with placebo). Although 25
mg of lamivudine was slightly less effective than 100 mg (P = .011) and
300 mg (P = .005), it still induced 94% suppression of HBV DNA after the
fourth week of therapy. HBV DNA values returned to pretreatment levels
within 4 weeks of cessation of therapy. There was no change in the
hepatitis B e antigen status or in aminotransferase levels. No serious
adverse events were observed. In conclusion, a 4-week course of
lamivudine was safe and effective in suppression of HBV DNA in Chinese
HBsAg carriers. The suppression was >90% but reversible. Studies with
long-term lamivudine administration should be performed to determine if
prolonged suppression of HBV DNA can be achieved.
*Antiviral Agents/THERAPEUTIC USE *Carrier State/DRUG THERAPY *DNA,
Viral/ANALYSIS *Hepatitis B/DRUG THERAPY *Hepatitis B Virus/DRUG
EFFECTS *Lamivudine/THERAPEUTIC USE