Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients.
OBJECTIVE
Clevudine has demonstrated antiviral potency in the treatment of naïve chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients.


METHODS
This is a post-marketing surveillance using case report forms which were submitted to the health authorities.


RESULTS
Analysis of individual data showed that hepatitis B virus (HBV) DNA after a 1-year treatment was <141,500 copies/ml in 96% of hepatitis B e antigen (HBeAg)-positive and 100% of HBeAg-negative patients. The proportion of patients with HBV DNA <2,000 copies/ml after a 1-year treatment was 74%: 71% of HBeAg-positive and 93% of HBeAg-negative patients. Most of the patients with HBV DNA below the detection limit with each assay at week 24 showed sustained viral suppression up to week 48. The proportion of patients who showed normal alanine aminotransferase at week 48 was 86% in HBeAg-positive patients and 87% in HBeAg-negative patients. The rates of HBeAg-loss were 21%. Two patients showed viral breakthrough during treatment.


CONCLUSIONS
Clevudine monotherapy demonstrates potent antiviral activity as well as biochemical and serological response with a 0.7% rate of viral breakthrough in naïve chronic hepatitis B patients.
Lee
June Sung
JS
Inje University Ilsanpaik Hospital, Goyang, Korea.
Park
Eun Taek
ET
Kang
Seung Sik
SS
Gu
Eun Sil
ES
Kim
Jong Sun
JS
Jang
Dong Seob
DS
Lee
Kyoung Seog
KS
Lee
Jae-Su
JS
Park
Nung Hwa
NH
Bae
Chang Hwang
CH
Baik
Soon Koo
SK
Yu
Byeong Jeon
BJ
Lee
Soon Hyung
SH
Lee
Eun Jong
EJ
Park
Sung Il
SI
Bae
Myoung
M
Shin
Jung Woo
JW
Choi
Jae Hong
JH
Gu
Chul
C
Moon
Sin Kil
SK
Chun
Gab Jin
GJ
Kim
Ju Hyun
JH
Kim
Hong Soo
HS
Choi
Sung-Kyu
SK
D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010949:Plasma / Q000821:virology; D017211:Treatment Failure; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D001086:Arabinofuranosyluracil; D000410:Alanine Transaminase; C034935:clevudine