title: Long-term treatment outcomes of clevudine in antiviral-naive patients with chronic hepatitis B.
abstract: OBJECTIVE
  To evaluate the treatment outcomes of clevudine compared with entecavir in antiviral-naive patients with chronic hepatitis B (CHB).
  
  
  METHODS
  We retrospectively analyzed the clinical data of CHB patients treated with clevudine 30 mg/d and compared their clinical outcomes with patients treated with entecavir 0.5 mg/d. The biochemical response, as assessed by serum alanine aminotransferase (ALT) activity, virologic response, as assessed by serum hepatitis B virus DNA (HBV DNA) titer, serologic response, as assessed by hepatitis B e antigen (HBeAg) status, and virologic breakthrough with genotypic mutations were assessed.
  
  
  RESULTS
  Two-hundred and fifty-four patients [clevudine (n = 118) vs entecavir (n = 136)] were enrolled. In clevudine-treated patients, the cumulative rates of serum ALT normalization were 83.9% at week 48 and 91.5% at week 96 (80.9% and 91.2% in the entecavir group, respectively), the mean titer changes in serum HBV DNA were -6.03 and -6.55 log(10) copies/mL (-6.35 and -6.86 log(10) copies/mL, respectively, in the entecavir group), and the cumulative non-detection rates of serum HBV DNA were 72.6% and 83.1% (74.4% and 83.8%, respectively, in the entecavir group). These results were similar to those of entecavir-treated patients. The cumulative rates of HBeAg seroconversion were 21.8% at week 48 and 25.0% at week 96 in patients treated with clevudine, which was similar to patients treated with entecavir (22.8% and 27.7%, respectively). The virologic breakthrough in the clevudine group occurred in 9 (7.6%) patients at weeks 48 and 15 (12.7%) patients at week 96, which primarily corresponded to genotypic mutations of rtM204I and/or rtL180M. There was no virologic breakthrough in the entecavir group.
  
  
  CONCLUSIONS
  In antiviral-naive CHB patients, long-term treatment outcomes of clevudine were not inferior to those of entecavir, except for virologic breakthrough.
authors: Department of Internal Medicine, Dankook University College of Medicine, Cheonan 330-715, South Korea.
authors: Suk Bae
authors: SB
authors: Kim
authors: Il Han
authors: IH
authors: Song
authors: Young Min
authors: YM
authors: Kim
authors: Ran
authors: R
authors: Noh
authors: Ha Yan
authors: HY
authors: Kang
authors: Hyang Ie
authors: HIe
authors: Lee
authors: Hyeon Yoong
authors: HY
authors: Yang
authors: An Na
authors: AN
authors: Kim
authors: Hee Bok
authors: HB
authors: Chae
authors: Sae Hwan
authors: SH
authors: Lee
authors: Hong Soo
authors: HS
authors: Kim
authors: Tae Hee
authors: TH
authors: Lee
authors: Young Woo
authors: YW
authors: Kang
authors: Eaum Seok
authors: ES
authors: Lee
authors: Seok Hyun
authors: SH
authors: Kim
authors: Byung Seok
authors: BS
authors: Lee
authors: Heon Young
authors: HY
authors: Lee
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D000998:Antiviral Agents / Q000494:pharmacology*; D001086:Arabinofuranosyluracil / Q000031:analogs & derivatives* / Q000494:pharmacology; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005838:Genotype; D006147:Guanine / Q000031:analogs & derivatives / Q000494:pharmacology; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D001086:Arabinofuranosyluracil; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase; C034935:clevudine
keywords: Chronic hepatitis B; Clevudine; Entecavir; Hepatitis B virus; Treatment outcomes