Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B

✍ Scribed by Byung Chul Yoo; Ju Hyun Kim; Young-Hwa Chung; Kwan Sik Lee; Seung Woon Paik; Soo Hyung Ryu; Byung Hoon Han; Joon-Yeol Han; Kwan Soo Byun; Mong Cho; Heon-Ju Lee; Tae-Hun Kim; Se-Hyun Cho; Joong-Won Park; Soon-Ho Um; Seong Gyu Hwang; Young Soo Kim; Youn-Jae Lee; Chae Yoon Chon; Byung-Ik Kim; Young-Suk Lee; Jin-Mo Yang; Haak Cheoul Kim; Jae Seok Hwang; Sung-Kyu Choi; Young-Oh Kweon; Sook-Hyang Jeong; Myung-Seok Lee; Jong-Young Choi; Dae-Ghon Kim; Yun Soo Kim; Heon Young Lee; Kwon Yoo; Hee-Won Yoo; Hyo-Suk Lee

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 314 KB
• Volume: 45
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.21629

✦ Synopsis

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.