2015年7月24日美国食品和药品监督局(FDA)批准Technivie (ombitasvir，paritaprevir和利托那韦[ritonavir])为使用与利巴韦林[ribavirin]联用在无疤痕和肝功能差(硬化)患者为丙型肝炎病毒(HCV)基因型4感染的治疗。
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，一种被FDA批准也用于治疗HCV感染药物。
FDA的药品评价和研究中心抗微生物产品室主任Edward Cox,M.D.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。”
肝炎C是一种病毒疾病致肝脏炎症可导致肝功能减低或肝衰竭。有感染HCV大多数人无疾病症状直至肝损伤变成明显，可能经历几年。有些人有慢性HCV感染跨越许多年发生硬化，它可能导致并发症例如出血，黄疸(淡黄眼或皮肤)，腹部积液，感染或肝癌。按照美国基本控制和预防中心，约2.7百万美国人被 HCV 感染，其中基因型4是最不常见之一。
在一项临床试验135例有慢性HCV基因型4感染无硬化参加者中评价Technivie与利巴韦林的安全和疗效。91例参加者接受Technivie与利巴韦林每天1次共12周。41例参加者接受Technivie每天1次无利巴韦林共12周。研究被设计成测量结束治疗后12周在参加者的血中是否不再检测到丙型肝炎病毒(持续病毒学反应)提示参加者的感染已被治愈。
结果显示100 %接受Technivie与利巴韦林的参加者实现一个持续病毒学反应。接受Technivie无利巴韦林的参加者，91%实现持续病毒学反应。
在临床试验中可得到对316例参加者有HCV用推荐剂量Technivie与其他抗-HCV药物联用治疗的安全性信息。在Technivie包括的三种药物也包括在Viekira Pak，以前被批准对HCV基因型 1感染的治疗。从Viekira Pak试验可得到对那些药物的另外安全性信息。Technivie与利巴韦林最常见副作用是疲乏，虚弱 (乏力)，恶心，失眠，瘙痒和其他皮肤反应。
Technivie携带一个警告警示患者和卫生保健提供者临床试验参加者的约1%发生肝酶升高大于正常上限5倍。在女性服用含炔雌醇避孕药发生更频。在开始Technivie前必须终止含炔雌醇避孕药。开始治疗的头四周期间和其后临床指示时进行肝实验室测试。
Technivie和Viekira Park是由总部在Illinois北芝加哥的AbbVie Inc上市。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full prescribing information for TECHNIVIE.
TECHNIVIE (ombitasvir, paritaprevir and ritonavir) tablets, for oral use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
TECHNIVIE is a fixed-dose combination of ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor and is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis. (1)
Limitations of Use: TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B). (1)
DOSAGE AND ADMINISTRATION
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Recommended dosage: Two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. TECHNIVIE is recommended to be used in combination with ribavirin. (2.1)
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Patient Population |
Treatment |
Duration |
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Genotype 4 without cirrhosis |
TECHNIVIE + ribavirin* |
12 weeks |
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*TECHNIVIE administered without ribavirin for 12 weeks may be considered for treatment-naïve patients who cannot take or tolerate ribavirin [see Microbiology (12.4) and Clinical Studies (14)]. |
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Hepatic impairment: TECHNIVIE is not recommended in patients with moderate hepatic impairment (Child-Pugh B). TECHNIVIE is contraindicated in patients with severe hepatic impairment (Child-Pugh C). (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir. (3)
CONTRAINDICATIONS
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The contraindications to ribavirin also apply to this combination regimen. (4)
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Patients with severe hepatic impairment. (4, 8.6.1, 12.3)
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Co-administration with drugs that are: highly dependent on CYP3A for clearance; moderate and strong inducers of CYP3A. (4)
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Known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
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ALT Elevations: Discontinue ethinyl estradiol-containing medications prior to starting TECHNIVIE (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment. For ALT elevations on TECHNIVIE, monitor closely and follow recommendations in full prescribing information. (5.1)
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Risks Associated With Ribavirin Combination Treatment: The warnings and precautions for ribavirin also apply to this combination regimen. (5.2)
Drug Interactions: The concomitant use of TECHNIVIE and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of TECHNIVIE. (5.3)
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence greater than 10% of subjects, all grades) observed with treatment with ombitasvir, paritaprevir and ritonavir with ribavirin for 12 weeks were asthenia, fatigue, nausea and insomnia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of TECHNIVIE can alter the plasma concentrations of some drugs and some drugs may alter the plasma concentrations of TECHNIVIE. The potential for drug-drug interactions must be considered before and during treatment. Consult the full prescribing information prior to and during treatment for potential drug interactions. (4, 5.3, 7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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