| 简介：
近日，美国食品药品监督管理局（以下简称FDA）批准Viekira Pak（ombitasvir+paritaprevir+ritonavir片剂联合dasabuvir片剂）用于治疗基因1型慢性丙型肝炎病毒（HCV）感染者，包括合并肝硬化的患者。丙肝是一种引起肝脏炎症的病毒性疾病，可导致肝功能下降、肝功能衰竭或肝癌。大多感染丙肝病毒的患者在出现明显肝损害前没有任何症状，这一潜伏期可达数十年。
据美国疾病控制与预防中心（CDC）的数据显示，美国约有320万人感染HCV，如果得不到适当治疗，其中将有15%～30%的感染者会发展成肝硬化。Viekira Pak包含三种新药—ombitasvir、paritaprevir和dasabuvir，这三种药物可协同抑制丙肝病毒的生长。
Viekira Pak还包含了之前获批用于增加血中paritaprevir浓度的药物—ritonavir。Viekira Pak可以和利巴韦林联合使用，也可以单独使用，但是不推荐失代偿期肝硬化的患者使用。
批准日期：2014年12月19日 公司：艾伯维（AbbVie）
Viekira Pak（Ombitasvir、Paritaprevir/Ritonavir片剂；Dasabuvir片剂），共包装供口服
美国初步批准：2014年
美国初步批准：2014年
近期重大变化
适应症及用法：4/2016
适应症和使用，删除使用限制：2015年10月
剂量和给药，开始前的测试
Viekira Pak:2015年10月
剂量和给药，成人推荐剂量：4/2016
给药、肝功能损害：2015年10月
禁忌症：4/2016
警告和预防措施：2015年10月
作用机理
Viekira-Pak将三种直接作用的丙型肝炎病毒抗病毒药物与独特的作用机制结合起来（见微生物学）。
利托那韦对丙型肝炎病毒无效。利托那韦是一种有效的CYP3A抑制剂，可增加帕拉普雷韦的峰值和谷值血浆药物浓度，并增加药物暴露（即曲线）。
适应症和使用
Viekira Pak适用于慢性丙型肝炎（HCV）成年患者的治疗：
•基因型1b无肝硬化或代偿性肝硬化
•基因型1a无肝硬化或代偿性肝硬化用于结合利巴韦林。
Viekira Pak包括ombitasvir、丙型肝炎病毒NS5a抑制剂、paritaprevir、丙型肝炎病毒NS3/4a蛋白酶抑制剂、ritonavir、acyp3a抑制剂和dasabuvir、丙型肝炎病毒非核苷NS5b。棕榈聚合酶抑制剂。
剂量和给药
开始前的测试-评估肝功能失代偿的实验室和临床证据。
推荐剂量：每日（早上）一次，服用两片奥比塔斯韦、帕瑞塔普瑞韦、利托那韦12.5/75/50毫克片剂，每日（早上和晚上）一次，每次饭后服用一片达沙布韦250毫克片剂，不考虑脂肪或热量。
按患者群体划分的治疗方案和持续时间
病患人数 治疗 持续时间
基因型1a，无肝硬化 Viekira-Pak+利巴韦林 12周
基因型1a，代偿性肝硬化 Viekira-Pak+利巴韦林 24周
1b基因型，有无代偿性肝硬化 维基拉帕克 12周
*注意：对于患有未知基因型1亚型或混合基因型1感染。
使用利巴韦林12周的Viekira Pak可能根据既往治疗史考虑部分患者[见临床研究。
•HCV/HIV共感染：患者与HCV/HIV共感染，后续的剂量超过建议的表。
•肝移植受助人的活体肝移植接受者运用：与normalhepatic功能和轻度纤维化（METAVIR纤维化评分≤2）所推荐的时间（viekira冰包和利巴韦林24周。
剂型和规格
片：
•ombitasvir，paritaprevir：12.5/利托那韦，75或50毫克
•dasabuvir 250毫克
contraindications
•与温和的两个病人的严重肝损害。
•如果viekira冰包管理与利巴韦林，contraindications toribavirin也适用于这两种组合方案。
禁忌证
如VIEKIRA PAK与利巴韦林给药，对利巴韦林禁忌证也应用于这个联用方案。
有严重肝受损患者。
与对清除是高度依赖CYP3A药物共同给药；CYP3A的中度或强诱导剂和strong 诱导剂 of CYP2C的强诱导剂；和CYP2C8的强抑制剂。
对利托那韦已知超敏性(如中毒性表皮坏死松解症，Stevens-Johnson综合征)。
警告和注意事项
ALT升高：开始VIEKIRA PAK前终止含炔雌醇[ethinyl estradiol]药物(建议另外避孕方法)。在治疗的头4周对所有患者进行肝实验室测试。对ALT升高对VIEKIRA PAK，严密监视和建议遵循完整处方资料中建议。
与利巴韦林联合治疗关联风险：如VIEKIRA PAK是与利巴韦林给药，对利巴韦林警告和注意事项也应用于这个联用方案。
药物相互作用：VIEKIRA PAK和某些其他药物的同时使用可能导致已知或潜在地显著药物相互作用，其中有些可能导致丧失VIEKIRA PAK的治疗作用。
不良反应
在接受VIEKIRA PAK与利巴韦林受试者中，最常报道不良反应(大于10%受试者)是疲乏，恶心，瘙痒，其他皮肤反应，失眠和虚弱。在接受VIEKIRA PAK无利巴韦林受试者中，最常报道不了反应(大于或等于5%受试者)是恶心，瘙痒和失眠。
报告怀疑不良反应，联系AbbVie Inc.电话1-800-633-9110或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.
药物相互作用
VIEKIRA PAK的共同给药可能改变某些药物血浆浓度和有些药物可能改变VIEKIRA PAK的血浆浓度。在治疗前和期间必须考虑药物相互作用潜能。对潜在药物相互作用治疗前和期间咨询完整处方资料。
供应/贮存和处置
VIEKIRA PAK为总共28天治疗在一个每月纸盒中发放。每个每月纸盒含四个每周纸盒。每个每周纸盒含7个每天剂量包装。
每个抗儿童每天剂量包装含四片：两片12.5/75/50mg ombitasvir，paritaprevir，利托那韦片和两片250mg dasabuvir片，和指示哪一片在早晨和傍晚服用。NDC码是NDC 0074-3093-28。
Ombitasvir，paritaprevir，利托那韦12.5/75/50 mg片是粉色，膜包衣，椭圆双凸形，一侧凹陷有“AV1”。Dasabuvir 250 mg片是米色，膜包衣，椭圆形，一侧凹陷有“AV2”。
储藏在或低于30°C(86°F)。
Viekira Pak is a prescription medication used to treat adult patients with chronic hepatitis C virus (HCV). Viekira Pak contains a combination tablet of the antiviral medications ombitasvir, paritaprevir, and ritonavir that is packaged with dasabuvir tablets. Viekira Pak is approved for use in those with HCV genotype 1b or genotype 1a. For those with genotype 1a, Viekira Pak is used in combination with ribavirin. People with a type of cirrhosis called “compensated” cirrhosis can also take Viekira Pak. This is a type of cirrhosis that has not progressed to an advanced stage called “decompensated” cirrhosis. Viekira Pak is not recommended for people with decompensated cirrhosis, which means that their livers have serious damage.1,2 There are two tablets in Viekira Pak. The pink-colored tablet contains the active ingredients of ombitasvir, paritaprevir, and ritonavir. The other, beige-colored tablet in Viekira Pak contains the active ingredient of dasabuvir.
How does Viekira Pak work?
Viekira Pak contains three antiviral drugs–ombitasvir, paritaprevir, and dasabuvir–that each work on blocking different substances that are essential for HCV to replicate. It also contains ritonavir, which does not work on HCV but boosts the amount and effectiveness of paritaprevir in the blood.
What are the possible side effects of Viekira Pak?
The most common side effects experienced by people taking Viekira Pak along with ribavirin in clinical trials were fatigue, nausea, itchiness or other skin reaction, difficulty sleeping (insomnia) and weakness or lack of energy. The most common side effects experienced by people taking Viekira Pak without ribavirin were nausea, itchiness, or difficulty sleeping.
Viekira Pak has a black box warning, the strictest warning from the U.S. Food and Drug Administration (FDA) because of its potential to cause serious side effects, namely the reactivation of hepatitis B virus (HBV) in people who carry the virus from a previous infection. This reactivation of HBV can result in liver failure and may lead to death.
Viekira Pak may cause severe liver problems, particularly in people with advanced cirrhosis. This may lead to the need for a liver transplant or death. In addition, Viekira Pak can cause increases in the enzyme ALT (alanine aminotransferase), which measures liver function. In clinical trials, increases in ALT were significantly more common in women who were using contraceptives with ethinyl estradiol, like oral contraceptives, contraceptive patches, or contraceptive vaginal rings.1
Things to know about Viekira Pak
Viekira Pak should not be used in people who have moderate to severe liver impairment. Prior to taking Viekira Pak, you should be tested for decompensated cirrhosis.
People who have a known hypersensitivity to ritonavir, like toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome, should not use Viekira Pak.
Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take, as some of these may interact with Viekira Pak. Some medications cannot be taken at the same time as Viekira Pak.
Pregnancy and breastfeeding
It is not known if Viekira Pak will harm your unborn baby. Be sure to talk to your doctor about plans for pregnancy and birth control before starting Viekira Pak. For both men and women who take Viekria Pak with ribavrian, during treatment and for the period of 6 months after treatment, you should use proper birth control measures to prevent pregnancy.
Additionally, it is not known if Viekira Pak passes into breast milk and poses a risk to your infant. Women who are breastfeeding or planning on breastfeeding should talk to their doctor about the risks to their child.1
Before taking Viekira Pak, you should be tested for hepatitis B virus (HBV). Viekira Pak can reactivate an infection of HBV, which could lead to liver failure or death. Those who have had a prior infection of HBV should be closely monitored while taking Viekira Pak.
Dosing information
Viekira Pak is taken by mouth. The recommended dose is two of the pink tablets (combination of ombitasvir, paritaprevir, and ritonavir) once each morning and the beige tablet (dasabuvir) twice daily, morning and evening. Viekira Pak should be taken along with a meal. The treatment duration is based on the genotype of HCV, but is usually 12 or 24 weeks.
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