PMID- 17464992
OWN - NLM
STAT- MEDLINE
DCOM- 20070525
LR  - 20220310
IS  - 0270-9139 (Print)
IS  - 0270-9139 (Linking)
VI  - 45
IP  - 5
DP  - 2007 May
TI  - Twenty-four-week clevudine therapy showed potent and sustained antiviral activity 
      in HBeAg-positive chronic hepatitis B.
PG  - 1172-8
AB  - 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. 
      CONCLUSION: 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.
FAU - Yoo, Byung Chul
AU  - Yoo BC
AD  - Samsung Medical Center, Sungkyunkwan University, and Yonsei University Hospital, 
      Seoul, Korea.
FAU - Kim, Ju Hyun
AU  - Kim JH
FAU - Chung, Young-Hwa
AU  - Chung YH
FAU - Lee, Kwan Sik
AU  - Lee KS
FAU - Paik, Seung Woon
AU  - Paik SW
FAU - Ryu, Soo Hyung
AU  - Ryu SH
FAU - Han, Byung Hoon
AU  - Han BH
FAU - Han, Joon-Yeol
AU  - Han JY
FAU - Byun, Kwan Soo
AU  - Byun KS
FAU - Cho, Mong
AU  - Cho M
FAU - Lee, Heon-Ju
AU  - Lee HJ
FAU - Kim, Tae-Hun
AU  - Kim TH
FAU - Cho, Se-Hyun
AU  - Cho SH
FAU - Park, Joong-Won
AU  - Park JW
FAU - Um, Soon-Ho
AU  - Um SH
FAU - Hwang, Seong Gyu
AU  - Hwang SG
FAU - Kim, Young Soo
AU  - Kim YS
FAU - Lee, Youn-Jae
AU  - Lee YJ
FAU - Chon, Chae Yoon
AU  - Chon CY
FAU - Kim, Byung-Ik
AU  - Kim BI
FAU - Lee, Young-Suk
AU  - Lee YS
FAU - Yang, Jin-Mo
AU  - Yang JM
FAU - Kim, Haak Cheoul
AU  - Kim HC
FAU - Hwang, Jae Seok
AU  - Hwang JS
FAU - Choi, Sung-Kyu
AU  - Choi SK
FAU - Kweon, Young-Oh
AU  - Kweon YO
FAU - Jeong, Sook-Hyang
AU  - Jeong SH
FAU - Lee, Myung-Seok
AU  - Lee MS
FAU - Choi, Jong-Young
AU  - Choi JY
FAU - Kim, Dae-Ghon
AU  - Kim DG
FAU - Kim, Yun Soo
AU  - Kim YS
FAU - Lee, Heon Young
AU  - Lee HY
FAU - Yoo, Kwon
AU  - Yoo K
FAU - Yoo, Hee-Won
AU  - Yoo HW
FAU - Lee, Hyo-Suk
AU  - Lee HS
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hepatology
JT  - Hepatology (Baltimore, Md.)
JID - 8302946
RN  - 0 (Antiviral Agents)
RN  - 0 (Hepatitis B e Antigens)
RN  - 0 (Placebos)
RN  - 3083-77-0 (Arabinofuranosyluracil)
RN  - EC 2.6.1.2 (Alanine Transaminase)
RN  - IN51MVP5F1 (clevudine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Alanine Transaminase/blood
MH  - Antiviral Agents/*therapeutic use
MH  - Arabinofuranosyluracil/*analogs & derivatives/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Hepatitis B/genetics
MH  - Hepatitis B e Antigens/*blood
MH  - Hepatitis B, Chronic/blood/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos
EDAT- 2007/04/28 09:00
MHDA- 2007/05/26 09:00
CRDT- 2007/04/28 09:00
PHST- 2007/04/28 09:00 [pubmed]
PHST- 2007/05/26 09:00 [medline]
PHST- 2007/04/28 09:00 [entrez]
AID - 10.1002/hep.21629 [doi]
PST - ppublish
SO  - Hepatology. 2007 May;45(5):1172-8. doi: 10.1002/hep.21629.