[Clinical efficacy of lamivudine in the treatment of chronic hepatitis B]

Full Abstract

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. CONCLUSION: 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.

Author information

Author/s: Ma, H (H); You, H (H); Yin, S (S);

Affiliation: Liver Research Center, Beijing Friendship Hospital, Capital University of Medical Sciences, Beijing 100050, China.

Journal and publication information

Publication Type: Clinical Trial; English Abstract; Journal Article; Randomized Controlled Trial

Journal: Zhonghua shi yan he lin chuang bing du xue za zhi = Zhonghua shiyan he linchuang bingduxue zazhi = Chinese journal of experimental and clinical virology (Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi), published in China. (Language: chi)

Reference: 2001-Jun; vol 15 (issue 2) : pp 147-9

Dates: Created 2001/07/04; Completed 2002/11/06; Revised 2006/11/15;

PMID: 11436644, status: MEDLINE (last retrieved date: 2/18/2009)

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