近日，美国FDA批准Technivie（ombitasvir/paritaprevir/ritonavir）联合利巴韦林（RBV）用于未发生肝硬化的基因型4丙肝（GT-4 HCV）成人患者的治疗。此次批准，使Technivie联合RBV疗法成为首个也是唯一一个用于基因型4丙肝的全口服、无干扰素、直接作用的鸡尾酒疗法，同时也标志着该基因型丙肝临床治疗的重大进步。Technivie联合RBV治疗12周，将提供一种治愈率（SVR12）达100%的治疗选择。需要注意的是，Technivie不推荐用于中度肝功能损害的患者（Child-Pugh B级）。
Technivie是一种全口服抗病毒药物，由固定剂量paritaprevir/ritonavir（150mg/100mg）与ombitasvir（25mg）复配而成。
Technivie每日口服一次，在进餐时服药，同时配合利巴韦林（1000mg或1200mg，根据体重调整，每日2次）。
Technivie与利巴韦林联用是第一个显示药物安全和疗效治疗基因型4 HCV感染无需干扰素的共同给药。优先审评。FDA的药品评价和研究中心抗微生物产品室主任说：“今天的批准提供对有基因型4 HCV感染患者无需使用干扰素的第一个治疗选择。”
批准日期：2015年7月24日；公司：AbbVie Inc.
TECHNIVIE（奥匹替韦/帕瑞普韦和/利托那韦[ombitasvir/paritaprevir/ritonavir]）片剂，用于口服
美国最初批准：2015年
警告：乙型肝炎病毒再激活的风险患有HCV和HBV的患者。
查看完整的盒装警告的完整处方信息。
已报道乙型肝炎病毒（HBV）再激活，在某些情况下导致暴发性肝炎，肝衰竭和死亡。
作用机制
TECHNIVIE结合了两种直接作用的丙型肝炎病毒抗病毒药物和独特的作用机制[见微生物学]。
利托那韦对HCV没有活性。利托那韦是一种有效的CYP3A抑制剂，可增加paritaprevir和整体药物暴露（即曲线下面积）的血浆药物浓度峰值和谷值。
适应症和用法
TECHNIVIE是ombitasvir，丙型肝炎病毒NS5A抑制剂，paritaprevir，丙型肝炎病毒NS3/4A蛋白酶抑制剂的固定剂量组合，和利托那韦，一种CYP3A抑制剂，与利巴韦林联合用于治疗基因4型慢性丙型肝炎病毒（HCV）感染但无肝硬化或代偿性肝硬化的患者。
剂量和给药
在开始治疗之前进行测试：
•通过测量HBsAg和抗HBc，对所有患者进行HBV感染检测。
•评估肝脏实验室和肝脏失代偿的临床证据。
在开始利巴韦林之前，评估潜在的心脏病。
•推荐剂量：每日一次（早上）与膳食一起口服两片，不考虑脂肪或卡路里含量。
建议将TECHNIVIE与利巴韦林联合使用。
患者人口                                 治疗        持续时间
基因型4没有肝硬化或代偿性肝硬化 TECHNIVIE +利巴韦林    12周
*没有利巴韦林治疗12周的TECHNIVIE可以考虑用于无肝硬化的未接受过治疗的患者，或者不能服用耐药性[见微生物学和临床研究]。
剂量形式和强度
片剂：12.5mg ombitasvir，75mg paritaprevir，50mg利托那韦。
禁忌症
•利巴韦林的禁忌症也适用于这种组合方案。
•中度至重度肝功能损害患者。
•与以下药物共同给药：高度依赖CYP3A进行清除;中度和强烈的CYP3A诱导剂。
•已知对利托那韦的超敏反应（例如中毒性表皮坏死松解症，Stevens-Johnson综合征）。
警告和注意事项
•乙型肝炎病毒重新激活的风险：
在开始HCV治疗之前，对所有患者进行当前或之前HBV感染的证据。监测HCV/HBV合并感染患者在HCV治疗期间和治疗后随后的HBV再激活和肝炎突发。根据临床指示，启动适当的HBV感染患者管理。
•肝硬化患者肝功能失代偿和肝功能衰竭：肝硬化患者主要报告肝功能失代偿和肝功能衰竭，包括肝脏移植或致死性疾病。
监测肝脏失代偿的临床症状和体征，并在发生肝脏补偿证据的患者中停止治疗。
•ALT升高：停止使用含有乙炔雌二醇的药物，开始使用TECHNIVIE（推荐使用其他避孕方法）。在治疗的前4周对所有患者进行肝脏实验室检测。对于TECHNIVIE上的ALT升高，请关闭并遵循完整处方信息中的建议。
•与利巴韦林联合治疗相关的风险：利巴韦林的警告和预防措施也适用于该组合方案。
•药物相互作用：同时使用TECHNIVIE和某些其他药物可能导致已知或潜在的重要药物相互作用，其中一些可能导致TECHNIVIE的治疗效果丧失。
不良反应
在没有肝硬化，无疲劳，恶心和失眠的患者中，使用ombitasvir，paritaprevirand ritonavir和利巴韦林治疗12周时观察到最常见的不良反应（发生率大于10％的受试者，所有等级）。
在补偿性肝硬化患者中使用TECHNIVIE和利巴韦林治疗12周时观察到的最常见不良事件（发生率大于10％的受试者，所有级别）是疲劳，虚弱，头痛，肌肉骨骼疼痛，瘙痒，失眠/睡眠障碍，皮肤反应，情绪失调，恶心，头晕和呼吸困难。
要报告疑似不良反应，请联系AbbVie Inc.at 1-800-633-9110或FDA，电话1-800-FDA-1088或www.fda.gov/medwatch。
药物相互作用
•共同使用TECHNIVIE可以改变某些药物的血浆浓度，某些药物可能会改变TECHNIVIE的血浆浓度。在治疗前和治疗期间必须考虑药物-药物相互作用的可能性。咨询完整的处方信息priorto和治疗期间潜在的药物相互作用。
•接受华法林治疗的患者建议经常监测国际标准化比值（INR）。
包装提供/存储和处理
TECHNIVIE每月分发一箱，共治疗28天。每月每月包含四个每周纸箱。 每周一次的纸箱包含七个每日剂量包。
每个儿童抗性日剂量包含两片TECHNIVIE片剂。 国家数据中心编号为0074-3082-28。
TECHNIVIE是一种粉红色，薄膜涂层，长方形，双凸形状的片剂，一面印有“AV1”。每片含有12.5mg ombitasvir，75mg paritaprevir和50mgritritonavir。
储存温度等于或低于30°C（86°F）。
完整说明资料附件：https://www.rxabbvie.com/pdf/technivie_pi.pdf
TECHNIVIE(ombitasvir, paritaprevir, and ritonavir tablets)Receives FDA Approval as the First and Only All-Oral, Interferon-Free Treatment for Genotype 4 Chronic Hepatitis C in the U.S.
U.S. 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).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.
About TECHNIVIE
TECHNIVIE 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.
Important Safety Information
USE
TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir) tablets is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C (hep C) virus infection without cirrhosis.
TECHNIVIE is not for people with certain types of liver problems.
IMPORTANT SAFETY INFORMATION
TECHNIVIE is taken in combination with ribavirin. People should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about TECHNIVIE?
TECHNIVIE can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen® Lo, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with TECHNIVIE. If these medicines are used as a method of birth control, another method must be used during treatment with TECHNIVIE, and for about 2 weeks after treatment with TECHNIVIE ends. A doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
A doctor may tell people to stop taking TECHNIVIE if signs or symptoms of liver problems develop. A doctor must be notified right away if any of the following symptoms develop or if they worsen during treatment with TECHNIVIE: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.