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Clevudine is highly efficacious in hepatitis B e antigen‐negative chronic hepatitis B with durable off‐therapy viral suppression
Author(s) -
Yoo Byung Chul,
Kim Ju Hyun,
Kim TaeHun,
Koh Kwang Cheol,
Um SoonHo,
Kim Young Soo,
Lee Kwan Sik,
Han Byung Hoon,
Chon Chae Yoon,
Han JoonYeol,
Ryu Soo Hyung,
Kim Haak Cheoul,
Byun Kwan Soo,
Hwang Seong Gyu,
Kim ByungIk,
Cho Mong,
Yoo Kwon,
Lee HeonJu,
Hwang Jae Seok,
Kim Yun Soo,
Lee YoungSuk,
Choi SungKyu,
Lee YounJae,
Yang JinMo,
Park JoongWon,
Lee MyungSeok,
Kim DaeGhon,
Chung YoungHwa,
Cho SeHyun,
Choi JongYoung,
Kweon YoungOh,
Lee Heon Young,
Jeong SookHyang,
Yoo HeeWon,
Lee HyoSuk
Publication year - 2007
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.21800
Subject(s) - medicine , hbeag , placebo , viral load , adverse effect , hepatitis b , virology , gastroenterology , hepatitis b virus , immunology , virus , hbsag , pathology , alternative medicine
Clevudine is a pyrimidine analog with potent and sustained antiviral activity against HBV. In the present study, we evaluated the safety and efficacy of clevudine 30 mg daily for 24 weeks and assessed the durability of antiviral response for 24 weeks after cessation of dosing in hepatitis B e antigen (HBeAg)‐negative chronic hepatitis B (e‐CHB). We randomized a total of 86 patients (3:1) to receive clevudine 30 mg (n = 63) or placebo (n = 23) daily for 24 weeks. We followed patients for an additional 24 weeks after withdrawal of treatment. The median changes in HBV DNA from baseline were −4.25 and −0.48 log 10 copies/mL at week 24 in the clevudine and placebo groups, respectively ( P < 0.0001). Viral suppression in the clevudine group was sustained after withdrawal of therapy, with 3.11 log 10 reduction at week 48. At week 24 and week 48, 92.1% and 16.4% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (<300 copies/mL). The proportion of patients who achieved ALT normalization was 74.6% and 33.3% in the clevudine and placebo groups at week 24, respectively ( P = 0.0006). ALT normalization in the clevudine group was well‐maintained during the post‐treatment follow‐up period. The incidence of adverse events was similar in the 2 groups. No resistance to clevudine was detected during treatment. Conclusion: A 24‐week clevudine therapy was well‐tolerated and showed potent and sustained antiviral effect without evidence of viral resistance in e‐CHB patients. However, treatment for longer than 24 weeks would be needed to achieve durable remission. (H EPATOLOGY 2007.)