Long-term treatment outcomes of clevudine in antiviral-naive patients with chronic hepatitis B  

作　　者：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 

机构地区：[1]Department of Internal Medicine,Dankook University College of Medicine,Cheonan 330-715,South Korea [2]Department of Internal Medicine,Eulji University College of Medicine,Daejeon 302-779,South Korea [3]Department of Internal Medicine,Chungbuk University College of Medicine,Cheongju 362-711,South Korea [4]Department of Internal Medicine,Soonchunhyang University College of Medicine,Cheonan 330-090,South Korea [5]Department of Internal Medicine,Konyang University College of Medicine,Daejeon 371-718,South Korea [6]Department of Internal Medicine,Chungnam University College of Medicine,Daejeon 301-721,South Korea

出　　处：《World Journal of Gastroenterology》2012年第47期6943-6950,共8页世界胃肠病学杂志（英文版）

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

关 键 词：Chronic hepatitis B Hepatitis B virus CLEVUDINE ENTECAVIR Treatment outcomes 

分 类 号：R512.62[医药卫生—内科学]