英文药名：TECHNIVIE(ombitasvir、paritaprevir、ritonavir tablets) 中文药名：奥匹替韦/帕瑞普韦和/利托那韦复方片 生产厂家：艾伯维公司 药品介绍 近日，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，用于口服使用 美国首次批准：2015年 警告： 丙型肝炎病毒与丙型肝炎病毒和乙型肝炎病毒感染患者的反应的风险查看完整的处方信息，提供完整的盒装警告。 已经报道了乙型肝炎病毒（HBV）再活化，在一些情况下导致暴发性肝炎，肝衰竭和死亡。 近期主要变化 警告：2/2017 剂量和给药：2/2017 禁忌：5/2016 警告和注意事项：2/2017 作用机制 TECHNIVIE结合了两种直接作用的丙型肝炎病毒抗病毒剂和不同的作用机制[参见微生物学]。 适应症和用途 TECHNIVIE是ombitasvir，丙型肝炎病毒NS5A抑制剂，paritaprevir，丙型肝炎病毒NS3/4A蛋白酶抑制剂和利托那韦（一种CYP3A抑制剂）的固定剂量组合，并且与利巴韦林联合用于治疗基因型4的患者 慢性丙型肝炎病毒（HCV）感染无肝硬化。 剂量和给药 治疗开始前的测试： 通过测量HBsAg和抗HBc，测试所有患者的HBV感染。 评估基线肝实验室和临床参数。 推荐剂量：两片口服每天一次（早上）用餐，不考虑脂肪或卡路里含量。建议将TECHNIVIE与利巴韦林联合使用。 患者人群治疗时间 基因型4无肝硬化TECHNIVIE+利巴韦林* 12周 *未服用利巴韦林12周的TECHNIVIE可被考虑用于不能服用或耐受利巴韦林的首次治疗患者[参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 ritonavir。 禁忌症 利巴韦林的禁忌症也适用于这种组合方案。 中重度肝损伤患者。 与以下药物的共同给药：高度依赖于CYP3A用于清除;中度和强的CYP3A诱导剂。 已知对利托那韦的超敏反应（例如毒性表皮坏死松解，史蒂文斯 - 约翰逊综合征）。 警告和注意事项 乙型肝炎病毒再激活的风险：在开始HCV治疗之前，测试所有患者的当前或先前HBV感染的证据。在HCV治疗和治疗后随访期间监测HCV / HBV共感染患者的HBV再激活和肝炎爆发。如临床指示的，启动适当的HBV感染的患者管理。 肝硬化的肝衰竭和肝功能衰竭：肝功能失代偿和肝功能衰竭，包括肝移植或致死性结果，主要报告在晚期肝硬化患者中。停止治疗发展肝失代偿证据的患者。 ALT立面：在开始TECHNIVIE之前停止含乙炔雌二醇的药物（推荐替代避孕方法）。在治疗的前4周对所有患者进行肝实验室检查。对于TECHNIVIE的ALT升高，密切监测和遵循建议在完整的处方信息。 与利巴韦林联合治疗相关的风险：利巴韦林的警告和注意事项也适用于这种联合治疗方案。 药物相互作用：伴随使用TECHNIVIE和某些其他药物可能导致已知或潜在显着的药物相互作用，其中一些可能导致TECHNIVIE的治疗效果的丧失。 不良反应 用ombitasvir，paritaprevir和利托那韦与利巴韦林治疗12周观察到的最常见的不良反应（大于10％的受试者，所有等级）是虚弱，疲劳，恶心和失眠。 共同管理TECHNIVIE可以改变一些药物的血浆浓度，一些药物可以改变TECHNIVIE的血浆浓度。在治疗之前和治疗期间必须考虑药物 - 药物相互作用的可能性。在治疗之前和治疗期间咨询完整的处方信息以了解潜在的药物相互作用。 供应/存储和处理 TECHNIVIE每月分装一次，共28天治疗。 每月每箱包含四个每周纸箱。 每个每周纸盒包含七个每日剂量包。 每个儿童抵抗每日剂量包装包含两个TECHNIVIE片。 NDC编号为0074-3082-28。 TECHNIVIE是一个粉红色，薄膜涂层，椭圆形，双面凸起的平板，一侧有“AV1”。 每片含有12.5mg奥匹替韦，75mg帕瑞普韦和50mg利托那韦。 储存温度应低于30°C（86°F）。 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85130606-e6a4-cf08-4bac-a460a30b0984 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).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 Study This 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 evaluated 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 Programs For 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 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 we