title: Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients.
abstract: 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.
authors: Inje University Ilsanpaik Hospital, Goyang, Korea.
authors: June Sung
authors: JS
authors: Lee
authors: Eun Taek
authors: ET
authors: Park
authors: Seung Sik
authors: SS
authors: Kang
authors: Eun Sil
authors: ES
authors: Gu
authors: Jong Sun
authors: JS
authors: Kim
authors: Dong Seob
authors: DS
authors: Jang
authors: Kyoung Seog
authors: KS
authors: Lee
authors: Jae-Su
authors: JS
authors: Lee
authors: Nung Hwa
authors: NH
authors: Park
authors: Chang Hwang
authors: CH
authors: Bae
authors: Soon Koo
authors: SK
authors: Baik
authors: Byeong Jeon
authors: BJ
authors: Yu
authors: Soon Hyung
authors: SH
authors: Lee
authors: Eun Jong
authors: EJ
authors: Lee
authors: Sung Il
authors: SI
authors: Park
authors: Myoung
authors: M
authors: Bae
authors: Jung Woo
authors: JW
authors: Shin
authors: Jae Hong
authors: JH
authors: Choi
authors: Chul
authors: C
authors: Gu
authors: Sin Kil
authors: SK
authors: Moon
authors: Gab Jin
authors: GJ
authors: Chun
authors: Ju Hyun
authors: JH
authors: Kim
authors: Hong Soo
authors: HS
authors: Kim
authors: Sung-Kyu
authors: SK
authors: Choi
mesh_terms: 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
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D001086:Arabinofuranosyluracil; D000410:Alanine Transaminase; C034935:clevudine