Clevudine

tangwanluyou

Conference Reports for NATAP

EASL 41st Meeting of the European Association for the Study of Liver Diseases Vienna, Austria April 26-30, 2006 Back

Clevudine 48 Weeks       Reported by Jules Levin EASL, April 2006, Vienna, Austria   "A 48-week clevudine therapy demonstrated significant viral suppression and biochemical improvement in naïve patients with chronic hepatitis B"   Young-Hwa Chung 1, KS Lee 2, JH Kim3, SH Ryu4, SW Paik 5, SH Um6, BH Han7, M Cho8, KS Byun 6, BI Kim5, JW Park9, HJ Lee10, JY Han 11, HC Kim12, SG Hwang13, K Yoo 14, YS Lee11, YJ Lee4, YS Kim15, JM Yang11, CY Chon2, SH Cho11, YS Kim16, SK Choi17, YO Kweon18, CJ Han19, JS Hwang20, MS Lee21, DG Kim22, HY Lee23, JY Choi11, HW Yoo24, MJ Otto25, PA Furman25, HS Lee26, BC Yoo 5 1AMC 2YUH 3GMS 4IUH 5SMC 6KUH 7KMS 8PNUH 9NCC 10YUMC 11CUK 12WUH 13PCUH 14EWUH 15IUH 16SCUH 17CNUH 18KNUH 19KIRMS 20KUDMC 21HUH 22CNUH 23CUH 24Bukwang Pharm. Co., Ltd. 25Pharmasset Inc. 26SNUH   Clevudine (L-FMAU) - Pyrimidine nucleoside analogue (L- enantiomer) - Potent inhibition of HBV replication Inhibition of synthesis of dsDNA from ssDNA Suppression of cccDNA - No cytotoxicity or mitochondrial toxicity - Rapid absorption, long half life - Major route of elimination: renal excretion L-FMAU, 1-(2-deoxy-2-fluoro-_-L-arabinofuranosyl)thymine   Clevudine showed potent and durable antiviral activities during a 12-week clevudine therapy in HBeAg-positive CH-B. Clevudine characteristically induced sustained post-treatment antiviral effects after the 12-week treatment period.   Baseline Characteristics of Naïve HBeAg+ CHB Patients Treated with Clevudine for 48 weeks (N=40)   N=9 HBV DNA >4,700 copies/mL Normal serum ALT   N=30 HBV DNA >4,700 copies/mL High serum ALT   N=1 HBV DNA <4,700 copies/mL Normal serum ALT   Baseline Characteristics of Naïve HBeAg- CHB Patients Treated with Clevudine for 48 weeks (N=15)   N=5 HBV DNA >4,700 copies/mL Normal serum ALT   N=10 HBV DNA >4,700 copies/mL High serum ALT   Inclusion and Exclusion Criteria of 24-week Clevudine Therapy   Inclusion Criteria - HBV DNA levels >106 copies/mL (1 million) - Serum ALT level: 2 to 10 times of ULN   Exclusion Criteria - HIV or HCV seropositivity - Hepatocellular carcinoma or decompensated LC - Other significant associated diseases in other organs - Breastfeeding and pregnant women - Previous treatment with any nucleoside analogue   Methods 1. Measurement of serum HBV-DNA Digene Ultra-sensitive Hybrid Capture II HBV DNA test -- From baseline to the end of the study. -- Lower LOD of 4,700 copies/mL   COBAS Amplicor HBV monitor test -- When HBV DNA levels reduced to <4,700 copies/mL -- Lower LOD of 300 copies/mL   2. Determination of HBeAg and Anti-HBe - Radioimmunoassay (Abbott Laboratories, North Chicago, IL)   3. Serum ALT level   Author Summary A 48-week clevudine therapy demonstrated significant viral suppression and biochemical improvement in naïve patients with chronic hepatitis B. -- Clevudine showed sustained antiviral effect after the cessation of therapy -- All the patients who achieved negative HBV-DNA by PCR at the week 24 showed sustained viral and biochemical responses during the maintenance therapy with lower dose. -- No serious adverse event was observed during the 48-week clevudine therapy.   Conclusion Clevudine may have promising potentials as a safe and effective antiviral agent for the treatment of chronic HBV infection.

tangwanluyou

From

http://www.natap.org/2006/EASL/EASL_30.htm

This is only one Phase III report what I search out.

jonchan

google翻译不出来

Clevudine是什么啊

看着好像是新药

tangwanluyou

克来夫定的其中一个三期临床报告，效果比恩替好。但是时间比较短(48周)。 对于e抗原阴性阳性都有很好的疗效。而且停药半年内，病毒量还在一定范围内。更进一步的三期临床试验，在2007年第三季度开始，现在2007年6月已经开始大量招人。

690402101

在哪呀？我想参加！我是小三样，是否够条件！