title: Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B.
abstract: Clevudine is a pyrimidine analogue with potent and sustained antiviral activity against HBV. The present study evaluated the safety and efficacy of 30 mg clevudine once daily for 24 weeks and assessed the durable antiviral response for 24 weeks after cessation of dosing. A total of 243 hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients were randomized (3:1) to receive clevudine 30 mg once daily (n=182) or placebo (n=61) for 24 weeks. Patients were followed for a further 24 weeks off therapy. Median serum HBV DNA reductions from baseline at week 24 were 5.10 and 0.27 log10 copies/mL in the clevudine and placebo groups, respectively (P<0.0001). Viral suppression in the clevudine group was sustained off therapy, with 3.73 log10 reduction at week 34 and 2.02 log10 reduction at week 48. At week 24, 59.0% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (less than 300 copies/mL). The proportion of patients who achieved normalization of alanine aminotransferase (ALT) levels was 68.2% in the clevudine group and 17.5% in the placebo group at week 24 (P<0.0001). ALT normalization in the clevudine group was well maintained during post-treatment follow-up period. The incidence of adverse events (AEs) was similar between the clevudine group and the placebo group. No resistance to clevudine was detected with 24 weeks of administration of drug.
  
  
  CONCLUSIONS
  A 24-week clevudine therapy was well tolerated and showed potent and sustained antiviral effect without evidence of viral resistance during treatment period in HBeAg-positive chronic hepatitis B.
authors.affiliation: Samsung Medical Center, Sungkyunkwan University, and Yonsei University Hospital, Seoul, Korea.
authors.forename: Byung Chul
authors.initials: BC
authors.lastname: Yoo
authors.forename: Ju Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Young-Hwa
authors.initials: YH
authors.lastname: Chung
authors.forename: Kwan Sik
authors.initials: KS
authors.lastname: Lee
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Paik
authors.forename: Soo Hyung
authors.initials: SH
authors.lastname: Ryu
authors.forename: Byung Hoon
authors.initials: BH
authors.lastname: Han
authors.forename: Joon-Yeol
authors.initials: JY
authors.lastname: Han
authors.forename: Kwan Soo
authors.initials: KS
authors.lastname: Byun
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
authors.forename: Heon-Ju
authors.initials: HJ
authors.lastname: Lee
authors.forename: Tae-Hun
authors.initials: TH
authors.lastname: Kim
authors.forename: Se-Hyun
authors.initials: SH
authors.lastname: Cho
authors.forename: Joong-Won
authors.initials: JW
authors.lastname: Park
authors.forename: Soon-Ho
authors.initials: SH
authors.lastname: Um
authors.forename: Seong Gyu
authors.initials: SG
authors.lastname: Hwang
authors.forename: Young Soo
authors.initials: YS
authors.lastname: Kim
authors.forename: Youn-Jae
authors.initials: YJ
authors.lastname: Lee
authors.forename: Chae Yoon
authors.initials: CY
authors.lastname: Chon
authors.forename: Byung-Ik
authors.initials: BI
authors.lastname: Kim
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Lee
authors.forename: Jin-Mo
authors.initials: JM
authors.lastname: Yang
authors.forename: Haak Cheoul
authors.initials: HC
authors.lastname: Kim
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Hwang
authors.forename: Sung-Kyu
authors.initials: SK
authors.lastname: Choi
authors.forename: Young-Oh
authors.initials: YO
authors.lastname: Kweon
authors.forename: Sook-Hyang
authors.initials: SH
authors.lastname: Jeong
authors.forename: Myung-Seok
authors.initials: MS
authors.lastname: Lee
authors.forename: Jong-Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Dae-Ghon
authors.initials: DG
authors.lastname: Kim
authors.forename: Yun Soo
authors.initials: YS
authors.lastname: Kim
authors.forename: Heon Young
authors.initials: HY
authors.lastname: Lee
authors.forename: Kwon
authors.initials: K
authors.lastname: Yoo
authors.forename: Hee-Won
authors.initials: HW
authors.lastname: Yoo
authors.forename: Hyo-Suk
authors.initials: HS
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000235:genetics; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D010919:Placebos; D001086:Arabinofuranosyluracil; D000410:Alanine Transaminase; C034935:clevudine