复方片ombitasvir/paritaprevir/ritonavir(Technivie)说明书

产地国家:加拿大

处方药:是

所属类别: (12.5毫克/75毫克/50毫克)/片 28片/盒

包装规格: (12.5毫克/75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:technivie tab (12.5mg/75mg/50mg)/tab 28tabs/box

原产地英文药品名:ombitasvir/paritaprevir/ritonavir

中文参考商品译名:technivie复方片 (12.5毫克/75毫克/50毫克)/片 28片/盒

中文参考药品译名:翁比他韦/帕利瑞韦/利托那韦

简介

TECHNIVIE(ombitasvir/paritaprevir/ritonavir)复方片,为口服使用美国初次批准:2015

作用机制

TECHNIVIE联合两种有不同作用机制直接作用丙肝病毒抗病毒药物[见微生物学]。利托那韦对HCV没有活性。利托那韦是一种强效CYP3A抑制剂增加paritaprevir的峰和低谷血浆药物浓度和药物总暴露(即,曲线下面积)。

适应证和用途

TECHNIVIE是一种固定剂量的ombitasvir,一种丙肝病毒NS5A抑制剂,paritaprevir,一种丙肝病毒NS3/4A蛋白酶抑制剂,和利托那韦,一种CYP3A抑制剂的组合和适用与利巴韦林[ribavirin]联用为有基因型4慢性丙型肝炎病毒(HCV)感染无硬化患者的治疗。

使用限制:建议TECHNIVIE不为在有中度肝受损患者(Child-Pugh B)使用。

剂量和给药方法

推荐剂量:两片每天1次口服(在早晨)与一餐不考虑脂肪或热量。建议TECHNIVIE与利巴韦林联用。

肝受损:建议在有中度肝受损(Child-Pugh B)患者不用TECHNIVIE。在有严重肝受损(Child-Pugh C)患者禁忌TECHNIVIE。

剂型和规格片

12.5mg ombitasvir,75mg paritaprevir,50mg利托那韦.

禁忌证

⑴对利巴韦林禁忌证也应用至这个联用方案。⑵有严重肝受损患者。⑶与以下药物共同给药:对清除高度依赖于CYP3A;CYP3A的中度和强诱导剂。⑷对利托那韦已知超敏性(如毒性表皮坏死松解症,Stevens-Johnson综合症)

警告和注意事项

⑴ALT升高:开始TECHNIVIE前(建议另外避孕方法)终止含炔雌醇[ethinyl estradiol]药物。对所有患者在治疗的头4周期间进行肝实验室测试。对用TECHNIVIEALT升高,严密监视和遵循在完全处方资料建议。

⑵与利巴韦林联合治疗伴随风险:The对利巴韦林警告和注意事项也应用于这个联用方案。

⑶药物相互作用:TECHNIVIE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TECHNIVIE 的治疗作用。

不良反应用

ombitasvir,paritaprevir和利托那韦与利巴韦林治疗共12周观察到最常报道不良反应(发生率大于10%受试者,所有级别)是虚弱,疲乏,恶心和失眠。

药物相互作用

TECHNIVIE的共同给药可能改变有些药物血浆浓度和有些药物可能改变TECHNIVIE的血浆浓度,治疗前和期间必须考虑对药物-药物相互作用潜能。

治疗前和期间对潜在药物相互作用咨询完整处方资料。

英文版说明书

Food and Drug Administration (FDA) approved TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. The approval of TECHNIVIE marks an important advancement in providing this historically difficult-to-treat population of HCV patients an opportunity for a cure. Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient’s blood 12 weeks after treatment (SVR12).1 TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).”Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C,” said Tarek Hassanein, M.D., professor of medicine, University of California San Diego School of Medicine. “The approval of TECHNIVIE in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure.”The FDA granted priority review to AbbVie for TECHNIVIE, a designation granted to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. This designation shortened the regulatory review period from the normal 10 months to six months. TECHNIVIE was also granted a Breakthrough Therapy designation by the FDA in 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.2″As demonstrated by the PEARL-I study results, TECHNIVIE delivers on AbbVie’s ongoing commitment to provide curative therapies for HCV patients who have historically been considered difficult-to-treat,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.About the PEARL-I StudyThis approval of TECHNIVIE is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that eva luated the efficacy and safety of TECHNIVIE in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking TECHNIVIE without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.There were no discontinuations due to adverse events in these patients. The most commonly reported treatment-emergent adverse events (greater than 10 percent in any group) observed in patients receiving TECHNIVIE or TECHNIVIE with RBV, respectively, were asthenia (weakness) (25-29 percent), fatigue (7-15 percent), nausea (9-14 percent) and insomnia (5-13 percent). Four patients who received TECHNIVIE with RBV experienced decreased hemoglobin (anemia) which required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. All patients treated with TECHNIVIE and RBV achieved SVR12.About AbbVie Patient Support ProgramsFor people living with chronic HCV infection who face financial difficulties, the AbbVie Patient Assistance Program provides AbbVie HCV medication at no cost to eligible patients. Additionally, AbbVie’s patient support program, called proCeed™, provides a broad range of patient support options. The proCeed program can be accessed at www.technivie.com or by calling 1-844-2-PROCEED.AbbVie also supports independent nonprofit organizations that assist eligible patients enrolled in federal and private insurance plans with their out-of-pocket medication costs.About TECHNIVIETECHNIVIE is an all-oral antiviral treatment consisting of the fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily and taken with a meal, which is co-administered with weight-based RBV (1000mg or 1200mg in divided doses, twice daily), taken with food. The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.About Hepatitis CHepatitis C is inflammation of the liver caused by an infection with the hepatitis C virus. It is transmitted when an infected person’s blood enters the bloodstream of another person. The Centers for Disease Control (CDC) estimates that 2.7 million people have chronic HCV infection in the U.S.4, which is more than two times as many people affected by the human immunodeficiency virus (HIV).5 There are six major HCV genotypes (GT1-6). While genotype 1 (GT1) is the most preva lent form of HCV in the U.S., accounting for approximately 74 percent of all cases6, GT4 infection is estimated to account for approximately 1.1 percent of HCV infections7, and was historically considered difficult-to-treat. It is estimated that more than one million people currently living with HCV will develop cirrhosis (scarring of the liver) by the year 2020,8 and with HCV-related liver transplants on the rise, it has become a critical public health issue. As the population ages and HCV progresses, it is projected that total annual direct medical costs of HCV in the U.S. will reach $85 billion over the next 20 years.9

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