Clinical and virological responses to clevudine therapy in chronic hepatitis B patients: results at 1 year of an open-labelled prospective study.
BACKGROUND
A previous clinical study of oral clevudine monotherapy for 24 weeks demonstrated that it has potent sustained antiviral effects without inducing drug resistance. The aim of this study was to evaluate the antiviral effects and safety of clevudine monotherapy for 12 months.


METHODS
In this open-labelled prospective study, 45 treatment-naive chronic hepatitis B patients treated with 30 mg clevudine once daily for 12 months were monitored at baseline and at 3-month intervals during treatment.


RESULTS
At baseline, the mean age of patients was 42 years, 32 were hepatitis B e antigen (HBeAg)-positive and 15 had liver cirrhosis. After 12 months of clevudine therapy, the mean serum hepatitis B virus (HBV) DNA level in HBeAg-positive patients had decreased by 4.6 log(10) IU/ml. Serum HBV DNA was undetectable in 68.7% of patients. HBeAg loss or seroconversion was observed in five patients (15.6%) and serum alanine aminotransferase (ALT) level had normalized after 12 months of treatment in 75% of patients. In all 13 HBeAg-negative patients, serum HBV DNA level was undetectable after 12 months of therapy and ALT level was normal in 61.5% of patients. Viral breakthrough occurred in one patient after 9 months of clevudine treatment. This patient had an HBV polymerase mutation, rtM204I. There were no serious adverse events.


CONCLUSIONS
One-year clevudine therapy is effective for suppressing serum HBV DNA level and for normalization of ALT level. Viral breakthrough associated with the rtM204I mutation in the HBV polymerase gene occurs during long-term clevudine treatment.
Ko
Soon Young
SY
Department of Internal Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, South Korea.
Kwon
So Young
SY
Choe
Won Hyeok
WH
Kim
Byung Kook
BK
Kim
Kyun-Hwan
KH
Lee
Chang Hong
CH
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006511:Hepatitis B Antigens / Q000032:analysis; D019694:Hepatitis B, Chronic / Q000188:drug therapy; D006801:Humans; D008103:Liver Cirrhosis; D008137:Longitudinal Studies; D008297:Male
D000998:Antiviral Agents; D004279:DNA, Viral; D006511:Hepatitis B Antigens; D001086:Arabinofuranosyluracil; D000410:Alanine Transaminase; C034935:clevudine