我开始使用TYZEKA(telbivudine)

brookfish

这个药的作用机理我还没搞清楚，我的医生现在正做这个药的课题，说我前面有几个试过，效果还可以。我会全程报道我的治疗过程。

GOOGLE了一下，这个药是2006年10份通过FDA的，是瑞士公司生产的，下面是简介：

Tyzeka was studied in a year-long international clinical trial involving 1,367 HIV-negative patients with chronic HBV. Three-quarters of the trial participants were male, and all were 16 years of age or older. The trial produced evidence of antiviral effectiveness, including the suppression of HBV, and improvement in liver inflammation comparable to Epivir®.

zxy84

Telbivudine (有人译成 太比夫定)，商品名Tyzeka, 也是核苷类似物。FDA于2006批准上市，用于乙肝治疗。疗效似乎优于 Lamivudine. 病毒变异也有发生, 只是较 Lamivudine 少。国内北京友谊医院今年也报道了临床试验结果 (Zhonghua Gan Zang Bing Za Zhi. 2007，15(5):342-5.)

 

下面是一份比较 Telbivudine 和 Lamivudine 临床疗效的表格 (Gastroenterology 2005,129:528-536,abbreviated). 这是个一年的临床试验。HBV DNA 定量用的 是 Cobas amplicor 系统 (最低检测极限 200 copies/ml)。

 

 

	lamivudine	telbivudine	telbivudine +lamivudine
N	19	44	41
Mean HBV DNA change (log 10 copies/ml)	-4.57	-6.01	-5.99
HBV DNA undetectable (%)	32	61	49
ALT normalization (%)	63	86	78
HBeAg seroconversion (%)	22	31	15
Viral breakthrough at wk 48(%)	15.8	4.5	12.2

medline

这个回的有质量。

brookfish

用药已经有1个半月了，中间只有两天肝部有些不适，还有两次由于劳累而浑身无力，其他时间都和正常人无别，食欲绝大部分时间都非常好，只有一次不想吃，且吃完想吐。从吃药到现在体重逐渐增加，现已恢复至肝功正常时水平。

下个月去做检查，到时再发结果上来。

brookfish

下面是我查到的一篇关于telbivudine的文章的摘要

Telbivudine for the treatment of chronic hepatitis B.

Dusheiko G, Danta M.

UCL Institute of Hepatology and Royal Free Hospital, London, UK. [email protected]

The hepatitis B virus (HBV) has a complex natural history and causes a wide spectrum of disease. Choices of therapy depend on a number of factors predictive of treatment response, clinical circumstances and stage of disease, and the likelihood and consequences of resistance to treatment. Telbivudine (beta-L-2'deoxythymidine) is a thymidine analogue that belongs to a new class of beta-L-configuration nucleoside analogues with specific activity against hepadnavirus. Phase III studies of telbivudine versus lamivudine in hepatitis B e antigen (HBeAg) and anti-HBe have been completed. In HBeAg-positive patients, HBV DNA was not detectable by polymerase chain reaction (PCR) assay in 56% of the HBeAg-positive patients receiving telbivudine after two years of treatment. In HBeAg-negative patients, at two years, HBV DNA was undetectable by PCR in 82% of HBeAg-negative patients (versus 52% of lamivudine recipients). Patients who were PCR-negative after 24 weeks were less likely to develop resistance. HBeAg seroconversion rates were also greatest in patients whose HBV DNA was undetectable at 24 weeks. These results are promising and could be used to devise a strategy to utilize combination therapy or to adjust therapy if an inadequate early viral response is observed. However, resistance is a potential shortcoming of the use of single agents for the treatment of HBV. (c) 2007 Prous Science. All rights reserved.

brookfish

另一篇是北京友谊医院做的，和ZXY说的是一篇，结果是:

1.替比夫定用药52周后降病毒能力高于拉米（6.2 log10 vs 5.4 log10）

2.拉米产生耐药性的病例是替比的两倍

3.24周时病毒载量越低，52周是用PCR检测不到病毒的可能性越大

4.24周时如果检测不到病毒，则疗效更好，变异率低，所以24周可以预测一年的疗效

[The degree of HBV suppression with 24 week telbivudine- or lamivudine-treatment in hepatitis B patients predicts the efficacy of the treatment at week 52]

[Article in Chinese]

Jia JD, Hou JL, Yin YK, Xu DZ, Tan DM, Niu JQ, Zhou XQ, Wang YM, Zhu LM, He YW, Ren H, Wan MB, Chen CW, Wu SM, Chen YG, Xu JZ, Wang QH, Wei L, Ma H.

Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China. [email protected]

OBJECTIVES: To investigate the possibilities of an association between the degrees of HBV suppression with nucleoside treatments at week 24 and week 52 in hepatitis B patients and to find a useful predictor for treatment efficacy. METHODS: In this phase III, double-blind, multicenter trial, we compared the efficacy of telbivudine treatment with lamivudine treatment in 332 Chinese compensated chronic hepatitis B patients. The patients were randomly assigned to a daily 600 mg telbivudine treatment group or daily 100 mg lamivudine group for 24 weeks. They were then categorized into 4 groups according to their serum HBV DNA levels (copies/ml) at week 24: a PCR-undetectable group (< 300 copies/ml); a QL- < 10(3) copies/ml group; a 10(3)-<10(4) copies/ml group; and a > or = 10(4) copies/ml group. The treatments were continued as they previously had been for another 28 weeks and the patients serum HBV DNA levels were examined again. RESULTS: At week 52, mean reductions of serum HBV DNA were significantly greater in the telbivudine-treated patients than in the lamivudine-treated group (6.2 log10 vs 5.4 log10, t = 3.6, P < 0.01). Viral resistance was twice as common in lamivudine-treated patients compared to those receiving telbivudine. Telbivudine was well-tolerated with an adverse event profile similar to that of lamivudine. The lower the HBV DNA level achieved at week 24, the higher HBV DNA non-detectable by PCR. ALT normalization and HBeAg seroconversion achieved at week 52, and viral resistance at week 48 decreased parallel to the degree of HBV DNA inhibition. CONCLUSION: HBV DNA PCR-undetectable at week 24 in nucleoside-treated hepatitis B patients suggests a better efficacy at week 52 and lower viral resistance at week 48. The degree of suppression of HBV at week 24 may be used as a predictor of 1-year outcome.

[此贴子已经被作者于2007-9-8 11:11:45编辑过]

liver411

就是数年前在精华版面提到的LDT。不知道他们研制的Valtorcitabine（LDC）目前怎样，很久没有去看。

特深沉

当时说LDC是和LDT伴随使用做的试验，并未单独做临床试验。