Clevudine

Presentations

Physician-sponsored Study 310
Clevudine is Superior to Lamivudine in Patients with HBeAg+ Chronic Hepatitis B
GK Lau, et al.
The 18th Conference of the Asian Pacific Association for the Study of the Liver (APASL)
Seoul, Korea
March 23-26, 2008

Physician-sponsored Study 310
Clevudine was Superior to Lamivudine in Patients with HBeAg+ Chronic Hepatitis B
GK Lau, et al.
Frontiers in Drug Development in Viral Hepatitis (HEP-DART)
Lahaina, Hawaii
December 9 - 13, 2007

Study 301
A 24-week Clevudine monotherapy produced profound on-treatment viral suppression as well as sustained viral suppression and normalization of aminotransferase levels for 24 weeks off-treatment in HBeAg(+) chronic hepatitis B patients
56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
San Francisco, CA USA
November 11-15, 2005

Study 302
Clevudine is highly efficacious in HBeAg(-) chronic hepatitis B patients with a sustained antiviral effect after cessation of therapy
56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
San Francisco, CA USA
November 11-15, 2005

Study 303
One-year treatment with Clevudine demonstrated significant viral suppression and biochemical improvement
41st Annual Meeting of the European Association for the Study of the Liver (EASL)
Vienna, Austria
April 26-30, 2006

Study 303
Six month maintenance therapy with 10 mg Clevudine maintains the viral suppression and biochemical improvement achieved with six months therapy with 30 mg
57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
Boston, MA  USA
October 27-31, 2006

Preclinical
Novel Mechanism of Action of Clevudine Triphosphate: Evidence for Non-competitive Inhibition of Hepatitis B Virus DNA Polymerase.
E Murakami, et al.
Frontiers in Drug Development in Viral Hepatitis (HEP-DART)
Lahaina, Hawaii
December 9-13, 2007

Preclinical
Clevudine is Efficiently Phosphorylated to the Active Triphosphate form in Human Hepatocytes
42nd Annual Meeting of the European Association for the Study of the Liver (EASL)
Barcelona, Spain
April 11-15, 2007

Preclinical
Anti-HIV Activity and Resistance Profiles of Entecavir Compared to Clevudine
16th International HIV Drug Resistance Workshop
St. Michael, Barbados
June 12-15, 2007

Publications

Niu C., Murakami E., and Furman PA. Clevudine is efficiently phosphorylated to the active triphosphate form in primary human hepatocytes. Antiviral Therapy, 13:263-269, 2008.

Yoo BC, et al. Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology, 46:1041-1048, August 2007.

Yoo BC, et al. Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology. 2007, Vol. 45, No. 5, pages 1172-1178.

Korba BE, Furman PA, and Otto MJ. 2006. Clevudine: A potent inhibitor of hepatitis B virus in vitro and in vivo. Expert Review of Anti-infective Therapy. 2006, 4(4): 549-561.

Zoulim F. Combination of nucleoside analogues in the treatment of chronic hepatitis B virus infection: lesson from experimental models. Journal of Antimicrobial Chemotherapy. 2005, Vol.55, 608–611.

Marcellin P, Mommeja-Marin H, Sacks SL, Lau GKK, Sereni D, Bronowicki J-P, Conway B, Trepo C, Blum MR, Yoo BC, Mondou E, Sorbel J, Snow A, Rousseau F, Lee H-S. A Phase II Dose-Escalating Trial of Clevudine in Patients with Chronic Hepatitis B. Hepatology. 2004, Vol.40, No.1.

Summers J, Mason WS. Residual integrated viral DNA after hepadnavirus clearance by nucleoside analog therapy. PNAS. 2004, Vol.101, No.2, 638-640.

Peek SF, Cote PJ, Jacob JR, Toshkov IA, Hornbuckle WE, Baldwin BH, Wells FV, Chu CK, Gerin JL, Tennant BC, Korba BE. Antiviral activity of clevudine [L-FMAU, (1-(2-fluoro-5-methyl-beta, L-arabinofuranosyl) uracil)] against woodchuck hepatitis virus replication and gene expression in chronically infected woodchucks (Marmota monax).Hepatology. 2001, 33:1(254-266).

Zhu Y, Yamamoto T, Cullen J, Saputelli J, Aldrich CE, Miller DS, Litwin S, Furman PA, Jilbert AR, Mason, WS. Kinetics of Hepadnavirus Loss from the Liver during Inhibition of Viral DNA Synthesis. J. Virology. 2001, Vol.75, No.1. 311-322.