Original Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Dec 21, 2012; 18(47): 6943-6950
Published online Dec 21, 2012. doi: 10.3748/wjg.v18.i47.6943
Long-term treatment outcomes of clevudine in antiviral-naive patients with chronic hepatitis B
Suk Bae Kim, Il Han Song, Young Min Kim, Ran Noh, Ha Yan Kang, Hyang Ie Lee, Hyeon Yoong Yang, An Na Kim, Hee Bok Chae, Sae Hwan Lee, Hong Soo Kim, Tae Hee Lee, Young Woo Kang, Eaum Seok Lee, Seok Hyun Kim, Byung Seok Lee, Heon Young Lee
Suk Bae Kim, Il Han Song, Young Min Kim, Ran Noh, Ha Yan Kang, Department of Internal Medicine, Dankook University College of Medicine, Cheonan 330-715, South Korea
Hyang Ie Lee, Hyeon Yoong Yang, An Na Kim, Department of Internal Medicine, Eulji University College of Medicine, Daejeon 302-779, South Korea
Hee Bok Chae, Department of Internal Medicine, Chungbuk University College of Medicine, Cheongju 362-711, South Korea
Sae Hwan Lee, Hong Soo Kim, Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan 330-090, South Korea
Tae Hee Lee, Young Woo Kang, Department of Internal Medicine, Konyang University College of Medicine, Daejeon 371-718, South Korea
Eaum Seok Lee, Seok Hyun Kim, Byung Seok Lee, Heon Young Lee, Department of Internal Medicine, Chungnam University College of Medicine, Daejeon 301-721, South Korea
Author contributions: Song IH designed this clinical study; Kim SB and Song IH performed data analysis and wrote the manuscript; Kim SB, Kim YM, Noh R and Kang HY interpreted data and drafted the manuscript; Lee HI, Yang HY, Kim AN, Chae HB, Lee SH, Kim HS, Lee TH, Kang YW, Lee ES, Kim SH, Lee BS and Lee HY took part in the study in their regional area and provided critical suggestions and discussion.
Correspondence to: Il Han Song, MD, PhD, Department of Internal Medicine, Dankook University College of Medicine, 16-5 Anseo-dong, Cheonan 330-715, South Korea. ihsong21@dankook.ac.kr
Telephone: +82-41-5503924 Fax: +82-41-5563256
Received: July 26, 2012
Revised: October 22, 2012
Accepted: October 30, 2012
Published online: December 21, 2012
Abstract

AIM: 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 log10 copies/mL (-6.35 and -6.86 log10 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.

CONCLUSION: In antiviral-naive CHB patients, long-term treatment outcomes of clevudine were not inferior to those of entecavir, except for virologic breakthrough.

Keywords: Chronic hepatitis B, Hepatitis B virus, Clevudine, Entecavir, Treatment outcomes