Korean J Hepatol.  2010 Sep;16(3):315-320. 10.3350/kjhep.2010.16.3.315.

Forty-eight weeks treatment with clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection: a double-blind randomized study

• Lau GK
• Leung N

• KMID: 1717327
• DOI: http://doi.org/10.3350/kjhep.2010.16.3.315

Abstract

BACKGROUND/AIMS
Clevudine is a pyrimidine analogue with potent activity against hepatitis B virus (HBV) replication in vitro. In a previous pivotal phase III clinical study, 24 weeks treatment with clevudine 30 mg has been shown to profoundly suppress HBV replication and normalize serum alanine aminotransferase level.
METHODS
In this study, we compare the efficacy and safety of clevudine (30 mg daily) versus lamivudine (100 mg daily) for 48 weeks in treatment-naive chronic hepatitis B e antigen (HBeAg) positive patients.
RESULTS
Ninety-two chronic HBeAg positive patients were randomized to receive clevudine 30 mg daily or lamivudine 100 mg daily in a 1:1 ratio. The clevudine group demonstrated greater viral suppression at week 48 when compared with the lamivudine group (median reduction: 4.27 vs. 3.17 log(10) copies/ml at week 48, p<0.0001). At week 48, serum HBV DNA level was below 300 copies/mL in 73% and 40% in the clevudine and lamivudine groups, respectively (p=0.001). HBeAg seroconversion occurred in 18% of patients in the clevudine group versus 12% in the lamivudine group at week 48. Lamivudine-resistant mutations were detected in 11 (24%) patients in the lamivudine group, who showed viral rebound during lamivudine therapy but no resistance was found in the clevudine group during 48-week treatment period.
CONCLUSIONS
A 48-week dosing with clevudine 30 mg daily was superior to lamivudine 100 mg daily in suppressing HBV replication, with no emergence of viral breakthrough in patients with HBeAg positive chronic hepatits B.

Keyword

Hepatitis B virus; Clevudine; Lamivudine; Clinical study; Resistance

MeSH Terms

Adult
Alanine Transaminase/blood
Antiviral Agents/*administration & dosage
Arabinofuranosyluracil/administration & dosage/*analogs & derivatives
DNA, Viral/blood
Double-Blind Method
Drug Administration Schedule
Drug Resistance, Viral
Female
Genotype
Hepatitis B e Antigens/blood
Hepatitis B, Chronic/*drug therapy
Humans
Lamivudine/*administration & dosage
Male
Middle Aged