利托那韦(VIEKIRAX COMBINATION TABLETS)说明书

产地国家:日本

处方药:是

所属类别: 13.6毫克/78.5毫克/50毫克/片 28片/盒

包装规格: 13.6毫克/78.5毫克/50毫克/片 28片/盒

计价单位:盒

生产厂家英文名:AbbVie

原产地英文商品名:VIEKIRAX COMBINATION TABLETS(ヴィキラックス配合錠)28Tablets/box

原产地英文药品名:Ombitasvir Hydrate/Paritaprevir Hydrate/Ritonavir

中文参考商品译名:Viekirax复方片(ヴィキラックス配合錠) 28片/盒

中文参考药品译名:Ombitasvir水合物/ Paritaprevir水合物/利托那韦

简介

部份中文Viekirax处方资料(仅供参考)

治疗类别名称:抗病毒化疗药物

批准日期:2014年11月

欧文商標名:VIEKIRAX

構造式一般名:オムビタスビル水和物(Ombitasvir Hydrate)[JAN]

化学名

Dimethyl N,N ‘-{(2S,5S)-1-[4-(1,1-dimethylethyl)phenyl]pyrrolidine-2,5-diyl}bis{[(4,1-phenyleneazanediyl)carbonyl][(2S)-pyrrolidine-2,1-diyl][(2S)-3-methyl-1-oxobutane-1,2-diyl]}biscarbamate heminonahydrate

分子式:C50H67N7O8・4 1/2 H2O

分子量:975.18

性状:白色是淡黄色或淡红色粉末或块。

構造式一般名:パリタプレビル水和物(Paritaprevir Hydrate)[JAN]

化学名

(2R,6S,12Z,13aS,14aR,16aS)-N-(Cyclopropylsulfonyl)-6-(5-methylpyrazine-2-carboxamido)-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[e]pyrrolo[1,2-a][1,4]diazacyclopentadecine-14a(5H)-carboxamide dihydrate

分子式:C40H43N7O7S・2H2O

分子量:801.91

性状:白色至是浅黄色粉末或块。

構造式一般名:リトナビル(Ritonavir)[JAN]

化学名

(+)-5-thiazolylmethyl[(αS)-α-[(1S,3S)-1-hydroxy-3-[(2S)-2-[3-[(2-isopropyl-4-thiazolyl)methyl]-3-methylureido]-3-methylbutyramido]-4-phenylbutyl]phenethyl]carbamate

分子式:C37H48N6O5S2

分子量:720.94

性状

在白色至浅黄褐色粉末,它也可以包括一个软质。审批条件在制定药品风险管理计划,要正确实现

药效药理

1. 作用机序Omubitasubiru是必不可少的HCV NS5A抑制剂病毒复制。 Paritapurebiru是在加工和由HCV基因编码的复合蛋白的病毒复制的必需的HCV NS3 / 4A蛋白酶的抑制剂。利托增加Paritapurebiru的血浆浓度。

2. 抗病毒活性OmubitasubiruOmubitasubiru,在HCV复制子细胞来抑制HCV的复制,EC 50值对于基因型1a-H77和1b-CON1,分别呈14.1和5.0pmol/ L。 Omubitasubiru是,HCV基因型2a,2b的抑制,3A,4A,HCV复制在从图5a和6a中,EC 50值分别12,4.3,19,1.7,3.2和366pmol/ L的含有NS5A复制子细胞这是。Paritapurebiru在酶抑制试验,Paritapurebiru抑制重组HCV基因型1a和1b NS3蛋白酶的IC 50值,分别为0.18和0.43nmol / L。 Paritapurebiru是,HCV基因型2a,图2b,可抑制从3a和4a衍生的纯化NS3蛋白酶的IC 50值,分别为2.4,6.3,14.5和0.16nmol/L。 Paritapurebiru,丙型肝炎病毒复制子细胞来抑制丙肝病毒的复制,基因型1A-H77和1b-CON1中,EC50值分别为1.0和0.21nmol/L。Paritapurebiru是抑制HCV复制中基因型2a-JFH-1复制子细胞,EC50值为5.3nmol/L。 Paritapurebiru是,HCV基因型3a中,以抑制HCV复制在含有NS3衍生4a和6a中,EC 50值复制子细胞,分别呈1​​9,0.09和0.68nmol / L。在复制子细胞,利托那韦,它不表现出抗HCV活性,并没有影响Paritapurebiru的抗HCV活性。Omubitasubiru和Paritapurebiru在HCV基因型1复制子细胞的结合,显示出所述添加剂的协同组合效应至多浓度进行了研究。

3. 药剂耐性Omubitasubiru在慢性丙型肝炎患者的基因型1b,Paritapurebiru,在与利托那韦的患者治疗,作为主要抗性突变的临床试验由病毒学治疗失败SVR12没有实现的L31F,Y93H或R30Q的Omubitasubiru,NS5A单独或L31M/ V或P58S和Y93H和双突变,以及一个主要抗性突变对Paritapurebiru,单独或NS3的Y56H的D168A/Ⅴ的双突变,观察病毒学治疗失败时。当HCV基因型1复制子细胞培养在存在Omubitasubiru或Paritapurebiru,接受表达突变,分别是NS5A或NS3的氨基酸取代。在HCV基因型1b复制子细胞,Y93H单独NS5A的R30Q或L31M和Y93H的双突变,主要是观察。 Omubitasubiru由L31F或Y93H突变的EC 50值,分别上升到10倍或77倍的野生型,R30Q,由L31M/ V或P58S和Y93H的双突变,上升到142至12328倍的野生型的这是。在HCV基因型1b复制子细胞,A156T和NS3的D168H/ V突变主要出现。 Paritapurebiru由A156T或D168A各EC 50值/ H / V抗性突变,增加至7倍或27-159倍的野生型的,它是由D168A/ V-Y56H双突变升高至700-2472倍的野生型。

4. 交叉耐药在转染的抗性突变蛋白酶抑制剂的HCV复制子细胞中的NS3/ 4A活性Omubitasubiru被保留,在染耐药突变对抗NS5A抑制剂活性Paritapurebiru的HCV复制子细胞获得保留。

适应病症

改善病毒血症慢性丙型肝炎或C的改进补偿1血清型肝硬化型(基因型1)

剂量和给药方法

每天一次口服给药,每次2片饭后口服给药

包装组合片剂:13.6毫克/78.5毫克/50毫克/片28片[7片(PTP)×4]

英文版说明书

Mechanism of action of Vicklax combination tablets: therapeutic agent for hepatitis CHepatitis C is known as a disease in which persistent inflammation occurs in the liver. When hepatitis C develops, damage to the liver accumulates, resulting in cirrhosis of the liver, further symptoms progressed and transition to liver cancer.Therefore, there is a Vickilux blended tablet as a medicine used to treat hepatitis C. Vickilux combination tablet is a medicine that combines three of ombitusville, paritapreville, ritonavir.Mechanism of action of Vicklax combination tabletsThere are several types of hepatitis. For example, hepatitis A or hepatitis B. These hepatitis occurs by the virus. Hepatitis A occurs by hepatitis A virus, and hepatitis B is caused by hepatitis B virus. Just like this, hepatitis C is associated with hepatitis C virus in the onset of the disease.Among these hepatitis, hepatitis C is highly likely to shift to “chronic hepatitis” where the symptoms of the disease will continue for a long time. Hepatitis A is called a fulminant type, and hepatitis never remains after the disease has developed. However, with hepatitis C, the disease persists for as long as it is.When thinking about treating such hepatitis C, you can see that it is better to eliminate the virus. Since symptoms are caused by hepatitis C virus, it eliminates the cause virus from the body.Work of OmbitusvilleHepatitis C virus has RNA in it, it is called RNA virus. RNA is genetic information similar to DNA, it is essential substance for virus to exist.Because all information is engraved on the gene, RNA must be replicated in order for hepatitis C virus to proliferate. At the time of RNA replication, after the virus invades the cell, based on the information inscribed in the RNA “factory for producing hepatitis C virus” will be made. This factory is called a duplicate complex in technical terms.Because hepatitis C virus is HCV (Hepatitis C Virus), the complex at this time is called HCV replication complex. Therefore, inhibiting the function of HCV replication complex can suppress the proliferation of hepatitis C virus.Among HCV replication complexes, ombitazir selectively acts on NS5A replication complex. Therefore, Ombitusville is called HCV-NS5A replication complex inhibitor.How the Paritapreville WorksProtein necessary for constructing hepatitis C virus is generated based on RNA information. Since protein at this time does not function as it is, it is necessary to cut it into an appropriate size.For example, when building a house, there is no point even if “a tree just cut away” is a material. By processing wood you need to work to function as wooden building. Just like this, it is necessary to trim down the protein that has been made once to break it down into functional forms. An enzyme that works like this is called a protease.Therefore, if you inhibit the function of protease, hepatitis C virus will not be able to produce the necessary protein to construct itself. As a result, virus growth is suppressed.Of the proteases, paritaprevir inhibits the enzyme called NS 3/4 A protease. This will try to treat hepatitis C.How ritonavir worksDrugs are foreign to the body, so they are metabolized in the liver or excreted from the kidneys. For example, in the former NS3/4A protease inhibitor “paritapreville” it is metabolized / detoxified by the enzyme present in the liver.Ritonavir has a potent inhibitory effect on liver metabolic enzymes (especially CYP4A3). In other words, it disables the function of liver metabolic enzymes. As a result, the NS3 / 4A protease inhibitor “paritapreville”, which was previously metabolized by the liver, will not be metabolized in the liver by the action of ritonavir.In other words, this will lead to strengthening the work of the NS3 / 4A protease inhibitor “paritapreville”. Since ritonavir increases the action of protease inhibitors, this is called boost effect.Characteristics of Vickilux blended tabletsIt is a Vicklax combination tablet with a hepatitis C remedy that combines three drugs, Ombitusville, Paritapreville, Ritonavir. It is a medicine that tried to obtain “HCV-NS5A replication complex inhibitory action”, “NS 3/4A protease inhibitory action”, “boost effect on protease inhibitor” by one drug.In the treatment of hepatitis C which has been done for a long time, the use of a medicine called interferon was indispensable. As you can see from the fact that interferon is a substance that occurs during a cold, the side effects of interferon are known as fever and chill. Therefore, the therapeutic drug released as a medicine not requiring interferon is Vickilux combination tablet.Hepatitis C can be divided into several types. Among them, genotype 1b type (about 70%), genotype 2a type (about 20%), genotype 2b type (about 10%) is the most common among Japanese people.Among them, Vickilux combination tablets are used for hepatitis C in Celo group 1 (genotype 1). In other words, it is used for genotype 1b type. This type of patients with chronic hepatitis C or liver cirrhosis will be used with Vikilux combination tablets.The main side effects are fatigue, itching (itching), weakness feeling, nausea, sleeping disorder, etc. are known. Take two tablets once a day and deal with the disease by continuing this for 12 weeks.With these characteristics, it is possible to obtain many actions with one tablet by combining three drugs, and interferon-free hepatitis C therapeutic drug is Vickilux combination tablet。

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