盐酸达卡他韦片daclatasvir(Daklinza Tablets 60mg)说明书

产地国家:日本

处方药:是

所属类别: 60毫克/片 14片/盒

包装规格: 60毫克/片 14片/盒

计价单位:盒

生产厂家英文名:Bristol-Myers Squibb

原产地英文商品名:Daklinza(ダクルインザ錠)60毫克/片 14片/盒

原产地英文药品名:Daclatasvir Hydrochloride

中文参考商品译名:Daklinza(ダクルインザ錠)60mg/Tablets 14Tabs/box

中文参考药品译名:盐酸达卡他韦

简介

部分中文盐酸达卡他韦处方资料(仅供参考)

英文名:daclatasvir

商标名:Daklinza Tablets

中文名:盐酸达卡他韦片

日文名:ダクルインザ錠60mg

生产商:百时美施贵宝

药品简介

丙型肝炎新药Daklinza(daclatasvir 中文译名:盐酸达卡他韦片)获批用于联合Sovaldi(sofosbuvir,索非布韦)用于基因型3慢性丙型肝炎(GT-3 HCV)成人患者的治疗。Daklinza是已经证明安全性和功效的治疗基因3的HCV感染,而不需要干扰素或利巴韦林共同给药的第一种药物药物分类名称抗病毒剂/ HCV NS5A复制复合物抑制剂批准日期:2014年9月

欧文商标名:Daklinza Tablets

一般名:ダクラタスビル塩酸塩(Daclatasvir Hydrochloride)

化学名:Dimethyl N,N ’-([1,1’-biphenyl]-4,4’-diylbis{1H-imidazole-5,2-diyl-[(2S)-pyrrolidine-2,1-diyl][(1S)-3-methyl-1-oxobutane-1,2-diyl]})dicarbamate dihydrochloride

分子式:C40H50N8O6・2HCl

分子量:811.80

性状

Daclatasville hydrochloride是一种白色至黄色粉末。易溶于水或二甲基亚砜,微溶于乙醇(99.5)。批准条件制定药品风险管理计划并适当实施。

药用药理学

1.作用机制Daclatasville是HCV NS5A复制复合物的有效选择性抑制剂。 HCV NS5A是参与HCV复制和细胞内信号传导途径调节的多功能蛋白。

2.抗病毒活性Daclatasville对HCV复制子测定中的多种基因型具有影响。对于基因型1a和1b,EC50值分别显示出0.003至0.050nmol/L和0.001至0.009nmol/L的强抑制作用。此外,它显示出对基因型2a的EC 50值为0.034至19nmol/L的抑制作用。在使用HCV复制子测定的组合研究中,Daclatasville与asnaprevir和干扰素α组合显示出相加或协同效应。

3.药物耐受性在临床试验中共同施用达卡他韦盐酸盐和Asunaprevir靶向患有慢性丙型肝炎基因型1b中,在患者体内,一个无效的时间,一般耐取代达卡他韦(对NS5A-Y93和/或L31没有达到SVR24取代的)与被取代的耐取代的(NS3-D168检测)为Asunaprevir。HCV复制子细胞的结果在存在达卡他韦培养,发生达卡他韦抗性。基因分型的多个是抗性表型相对于达卡他韦的氨基酸1至100号,观察到NS5A的取代基的的结果。对于基因型1b,在L31和Y93的氨基酸残基的频率观察到高电阻置换,氨基酸的情况下换人一个位置,EC50值小于30倍的野生型,在这两个位置的酸如果存在取代(例如L31 V – Y 93 H),则EC 50值是野生型的1000倍以上。

4.交叉耐受HCV复制子耐取代达卡他韦是Asunaprevir不得不聚乙二醇干扰素α足够的灵敏度。

适应症

改善慢性丙型肝炎或C型肝硬化血清群1(基因型1)中的病毒血症。

用法与用量

成人,每天口服一次,每次服60毫克。该药与阿那普韦韦联合使用,给药期为24周。

包装

片剂60毫克:14片(14片×1)

英文版说明书

Hepatitis C new drug daclatasvir+asunaprevir oral solution approved by JapanOn July 7, 2014, the Japanese Ministry of Health, Labor and Welfare approved the company’s daclatasvir (Daklinza) + asunaprevir (Sunvepra) combination for the treatment of hepatitis C virus (HCV) genotype 1 infection, including treatment Those who have modern compensatory cirrhosis.Daclatasvir is a potent, all-gene NS5A replication complex inhibitor; and asunaprevir is an NS3/4A protease inhibitor. In Japan, the combination of these two drugs was the first non-interferon, ribavirin-free oral regimen that was formally approved for the treatment of HCV infection. This therapy combines the NS5A inhibitor daclatasvir and the NS3/4A protease inhibitor asunaprevir. This therapy is primarily designed to treat patients with genotype 1 hepatitis C. This is also the first full oral hepatitis C therapy in the world to officially enter the market.In Japan, the daclatasvir+asunaprevir combination regimen is for patients with chronic HCV genotype 1 infection with or without compensatory cirrhosis. These patients cannot tolerate or apply interferon-based treatment regimens or interferon-containing treatments. The protocol has no response; the combination is intended to improve viremia in this population.Daclatasvir is a potent, all-gene NS5A replication complex inhibitor; while asunaprevir is a NS3/4A protease inhibitor. In Japan, the combination of these two drugs was the first non-interferon-free, ribavirin-free oral regimen that was formally approved for the treatment of HCV infection.At the press conference, Bristol-Myers Squibb said that about 70% of the Japanese hepatitis C carriers were infected with the HCV gene type 1b. Dr. Kazuaki-Chayama of Hiroshima University in Japan said that there is a unique population of HCV patients in Japan, many of whom are older and cannot tolerate or respond to traditional treatments. Therefore, it is urgent to seek an effective treatment plan for this group of people.Dr. Chayama believes that the daclatasvir+asunaprevir combination regimen has been officially approved by the Japanese authorities, and for many of these HCV-infected people in Japan, for the first time, a new medication option has been obtained.In Japan, the daclatasvir+asunaprevir combination regimen is for patients with chronic HCV genotype 1 infection with or without compensatory cirrhosis. These patients cannot tolerate or apply interferon-based treatments or interferon-containing treatments. The protocol has no response; the combination is intended to improve viremia in this population.The research team led by Dr. Chayama conducted a phase III clinical trial. The results showed that Japanese HCV genotype 1 infected patients received the daclatasvir+asunaprevir regimen, and 84.7% of patients achieved a sustained virological response (SVR24) 24 weeks after the end of treatment.Among patients with hepatitis C who were unable to tolerate or were not eligible for interferon regimen over the age of 65, 91.9% of patients achieved SVR24 after treatment with this regimen; the proportion of patients with modern compensatory cirrhosis at baseline reached an SVR24 ratio of 90.9%.Only 5% of the subjects discontinued treatment because of adverse reactions. Among them, the incidence of serious adverse events was low (5.9%), and almost no serious adverse reactions occurred in more than one patient. Overall, nasopharyngitis is the most common adverse reaction (30.2%).

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