[Clinical efficacy of lamivudine in the treatment of chronic hepatitis B].
OBJECTIVE
To study the clinical efficacy and safety of lamivudine in the treatment of chronic hepatitis B.


METHODS
72 patients with hepatitis B were randomly assigned into lamivudine (n = 54) and placebo groups (n = 18) for 12 weeks. Then, all the patients received lamivudine 100 mg daily until week 104. Clinical symptoms, liver function tests, serum HBV DNA and YMDD mutation were evaluated.


RESULTS
HBV DNA response rate of lamivudine group was higher than that of placebo group after 12 weeks treatment (61% vs 6%, P < 0.01). ALT sustained normalization rate of lamivudine group was higher than that of placebo group (65% vs 11%, P < 0.05). At week 52 and week 104, HBV DNA response rate was 78% and 36% respectively, whereas the normalization rate of ALT was 39% and 33% respectively. Proportion of HBeAg/anti-HBe seroconversion was both 6.1% at week 52 and 104. Overall YMDD mutation rate was 13.7% at week 52 and 39.7% at week 104. The incidence of adverse effects was similar for lamivudine and placebo group at week 12. There was no severe drug-related adverse events during 104 weeks treatment.


CONCLUSIONS
Lamivudine 100 mg daily could suppress HBV replication rapidly and be well tolerated. However, in some cases, YMDD mutation may lead to HBV DNA breakthrough.
Ma
H
H
Liver Research Center, Beijing Friendship Hospital, Capital University of Medical Sciences, Beijing 100050, China.
You
H
H
Yin
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D009154:Mutation
D000998:Antiviral Agents; D004279:DNA, Viral; D019259:Lamivudine