阿地福韦长期用药效益和副作用的研究

liver411

****** From: "Doc" gidoc@XXXXXXX To: [email protected] Subject: [HB] Long term use of Adefovir Date: Tue, 23 Jul 2002 17:14:29 +0530 SUSTAINED ANTIVIRAL RESPONSE AND LACK OF VIRAL RESISTANCE WITH LONG TERM ADEFOVIR DIPIVOXIL (ADV) THERAPY IN CHRONIC HBV INFECTION Elizabeth Heathcote1 Lennox Jeffers2 Robert Perrillo3 Teresa Wright4 Morris Sherman5 Hamid Namini6 Shelly Xiong6 Craig James6 Victoria Ho6 John Fry6 Carol Brosgart6 1=West Division, The Toronto Hospital, Toronto, Canada, USA 2=Center for Liver Disease, University of Miami, Miami, Florida, USA 3=Gastroenterology Department, Ochsner Medical Center, New Orleans, Louisiana, USA 4=GI Unit, San Francisco VA Medical Center, San Francisco, California, USA 5=Toronto General Hospital, Toronto, Ontario, Canada 6=Clinical Research, Gilead Sciences, Foster City, California, USA Objective: To evaluate long-term safety, antiviral activity, and viral resistance in a Phase II, open-label, extension study. Methods: 39 patients (28 HBeAg+ and 11 precore mutants) who completed Phase II ADV studies were enrolled. Patients initially received 30 mg daily, but were dose reduced to 10 mg daily for chronic therapy. Results: At baseline, median age: 41, male: 85%, Asian: 51%, precore mutants: 28%, median HBV DNA: 8.02 log10 copies/mL (Roche PCR), median ALT: 83 IU/L. To date, 21 patients continue ADV with median duration of ADV, 88 weeks (range 4-136). Median HBV DNA reductions of 3.40 (p<0.0001, N=33) and 3.36 (p<0.0001, N=23) log10 copies/mL observed at Week 48 and 100, respectively. By Week 100, HBV DNA was undetectable (<400) in 70% of patients. Median ALT reductions of 36 (N=30) and 48 IU/L (N=22) observed at Week 48 and 100, respectively. By Week 100, ALT normalization was seen in 19/22 (70%) patients. HBeAg seroconversion demonstrated in 6/28 (21%) HBeAg+ patients. Genotypic analysis of HBV polymerase up to 136 weeks revealed no mutations associated with ADV resistance. One patient discontinued ADV due to confirmed elevated serum creatinine level (peak: 1.4 mg/dL). No patient experienced confirmed serum phosphorus <1.5 mg/dL. Conclusions: Sustained antiviral activity and improvement of ALT demonstrated in both wild type and precore mutant chronic HBV patients treated up to 136 weeks with no evidence of adefovir-related resistance. HBeAg seroconversion demonstrated in HBeAg+ patients. Long-term treatment is not associated with treatment-limiting toxicity in majority of patients. _______________________________________________________________ Subscription Options & Disclaimer www.geocities.com/Heartland/Estates/9350/hblist.html Hepatitis B Frequently Asked Questions (FAQ's) www.geocities.com/Heartland/Estates/9350/faq.html

rising

效果不错。

wwjj2002

不知道是否对前C/c变异是否有效？

liver411

"不知道是否对前C/c变异是否有效？"

YES!......

Sustained antiviral activity and improvement of ALT demonstrated in both wild type and precore mutant chronic HBV patients treated up to 136 weeks with no evidence of adefovir-related resistance.

显著, 持续的抗病毒和减低转氨酶作用在野生株和前C区变异体病毒感染的病人中都明显显示, 并且在长达136个星期用药中没有出现对ADV的抗药现象.

文正

看不懂啊，请特深沉兄翻译一下。谢谢。

ymdd

好像比拉米来的慢。

Ryan

期待中……

feeling

哪里有临床试验？

消灭HBV

就是药费太贵了，一年要一万呢，不过如果比拉米好，贵点也值得。