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。
批准日期：2015年7月24日；公司：AbbVie Inc.
Technivie(ombitasvir，paritaprevir和利托那韦)片，为口服使用 
TECHNIVIE Rx 
Generic Name and Formulations:
Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg; tabs.

Company:
AbbVie
Indications for TECHNIVIE:
Chronic HCV genotype 4 infection without cirrhosis, in combination with ribavirin.

Limitations Of use:
Not for use in patients with moderate hepatic impairment.

Adult:
Take with a meal. ≥18yrs: 2 tabs once daily in the AM for 12 weeks with ribavirin. Treatment-naive (or ribavirin intolerant): may consider administering without ribavirin for 12 weeks.

Children:
<18yrs: not established.

Contraindications:
Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, rifampin, ergots, ethinyl estradiol, St. John’s wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil (as Revatio), triazolam, oral midazolam. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Cat.X).

Warnings/Precautions:
Monitor hepatic function prior to initiation, during the first 4 weeks, and as clinically indicated thereafter. Consider discontinuing if ALT persistently >10XULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. HCV/HIV-1 co-infected: give suppressive antiretroviral regimen. Pregnancy (Cat.B). Use progestin-only contraception or non-hormonal methods during therapy. Nursing mothers.

Interactions:
See Contraindications. Increased risk of ALT elevations esp. in females using ethinyl estradiol-containing drugs; discontinue prior to starting; may resume 2 weeks after Technivie completion. May potentiate substrates of CYP3A, P-gp, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant voriconazole, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Technivie; monitor tacrolimus levels and renal function. Concomitant quetiapine: consider alternative anti-HCV therapy; if necessary, reduce quetiapine to 1/6 of current dose and monitor. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant darunavir 800mg (without ritonavir): take at same time as Technivie. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor digoxin levels; decrease digoxin dose by 30–50%. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam.

Pharmacological Class:
HCV NS5A inhibitor + HCV NS3/4A protease inhibitor + CYP3A inhibitor.

Adverse Reactions:
Asthenia, fatigue, nausea, insomnia, pruritus, skin reactions; ALT and bilirubin elevations.

Note:
For ribavirin specific dosing and safety information, refer to the full prescribing information.

Generic Availability:
NO

How Supplied:
Monthly carton—4 x 7 daily dose packs