Treatment outcomes of clevudine versus lamivudine at week 48 in naïve patients with HBeAg positive chronic hepatitis B

J Korean Med Sci. 2010 May;25(5):738-45. doi: 10.3346/jkms.2010.25.5.738. Epub 2010 Apr 16.

Abstract

The authors assessed the efficacy and antiviral resistance of 48-week clevudine therapy versus lamivudine in treatment of naïve patients with HBeAg positive chronic hepatitis B. In this retrospective study, a total of 116 HBeAg positive patients, who received 30 mg of clevudine once daily (n=53) or 100 mg of lamivudine once daily (n=63) for 48 weeks, were included. At week 48, clevudine therapy produced a significantly greater mean reductions in serum HBV DNA levels from baseline than lamivudine therapy (-5.2 vs. -4.2 log(10)IU/mL; P=0.005). Furthermore, a significantly higher proportion of patients on clevudine achieved negative serum HBV DNA by PCR (<13 IU/mL) at week 48 (60.4% vs. 38.1%; P=0.025). The incidence of virologic breakthrough in the clevudine group was significantly lower than in the lamivudine group (9.4% vs. 25.4%; P=0.031). However, rates of alanine aminotransferase normalization and HBeAg loss or seroconversion were similar in the two groups (83.0% vs. 81.0%, 11.3% vs. 11.1%; P=0.813, 1.000, respectively). In conclusion, clevudine is more potent for viral suppression and lower for antiviral resistance at week 48 than lamivudine in treatment of naïve patients with HBeAg positive chronic hepatitis B.

Keywords: 2'-fluoro-5-methylarabinosyluracil; Hepatitis B, Chronic; Lamivudine; Virologic Breakthrough.

Publication types

  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Arabinofuranosyluracil / administration & dosage
  • Arabinofuranosyluracil / analogs & derivatives*
  • Drug Resistance, Viral
  • Female
  • Hepatitis B e Antigens / blood*
  • Hepatitis B, Chronic / diagnosis
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / immunology*
  • Humans
  • Lamivudine / administration & dosage*
  • Male
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Hepatitis B e Antigens
  • Lamivudine
  • Arabinofuranosyluracil
  • clevudine