Six month maintenance therapy with 10 mg clevudine maintains the viral suppression and biochemical improvement achieved with six months therapy with 30 mg

Abstract

Background: In the pivotal phase III clinical trials, clevudine 30 mg once daily for 6 months showed potent antiviral activity along with a marked post-treatment antiviral effect. E-max modeling has shown that the 30 mg dose achieved >90% of maximum predicted effect compared to approximately 77% at the 10 mg dose.

Objective: To evaluate the effect of 6 months maintenance therapy with 10 mg clevudine once daily in treatment-naive patients following 6 months therapy at 30 mg once daily.

Method: Safety, antiviral activity, biochemical improvement and serologic response were monitored in patients receiving clevudine 30 mg for 24 weeks followed by clevudine 10 mg for an additional 24 weeks as a maintenance therapy with a 12-week follow-up period. Preliminary results from the 54 naive patients (39 HBeAg(+), 15 HBeAg(-)) who have completed the study are presented here.

Results: The table below summarizes the results of this study.

Conclusion: Clevudine 30 mg once daily therapy was well tolerated and demonstrated significant viral suppression and biochemical improvement. While a maintenance dose of 10 mg once daily is not recommended due to the potential for resistance selection, it was able to sustain the antiviral and biochemical responses achieved with 30 mg.