VIEKIRA PAK(ombitasvir，paritaprevir，ritonavir；dasabuvir)片组合包装为治疗慢性丙型肝炎病毒(HCV)基因型1感染患者，包括患有肝硬化的患者的新药
批准日期: , 2014年12月19日；公司: AbbVie Inc.
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis (decompensated). If you have cirrhosis, talk to your healthcare provider before taking VIEKIRA.

VIEKIRA PAK Rx
Generic Name and Formulations:
Ombitasvir/paritaprevir/ritonavir 12.5mg/75mg/50mg; with dasabuvir 250mg; tabs.

Company:
AbbVie

Indications for VIEKIRA PAK:
Chronic HCV genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis.

Limitations Of use:
Not for use in patients with decompensated liver disease.

Adult:
Take with a meal. ≥18yrs: Give 2 ombitasvir/paritaprevir/ritonavir tabs once daily (in AM) and 1 dasabuvir tab twice daily (AM & PM). Genotype 1a without cirrhosis or genotype 1b with cirrhosis: treat for 12 weeks with ribavirin. Genotype 1a with cirrhosis: treat for 24 weeks with ribavirin (based on prior treatment history, 12 weeks treatment may be considered for some patients). Genotype 1b without cirrhosis: treat for 12 weeks. HCV/HIV-1 co-infection: follow recommendations above. Liver transplant recipients (with mild fibrosis): treat for 24 weeks with ribavirin. In combination with ribavirin: see full labeling.

Children:
<18yrs: not established.

Pharmacological Class:
HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A inhibitor + HCV NS5B palm polymerase inhibitor.

Contraindications:
Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, ergot derivatives, ethinyl estradiol-containing products, 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 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. Dialysis: not studied. Moderate hepatic impairment: not recommended. Pregnancy (Cat.B). Use progestin-only contraception or non-hormonal methods, if necessary. Nursing mothers.

Interactions:
See Contraindications. Discontinue ethinyl estradiol-containing products prior to starting; may resume 2 weeks after therapy completion. May potentiate substrates of CYP3A, UGT1A1, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or CYP2C8, P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), rosuvastatin (max 10mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant calcineurin inhibitors (in liver transplant): adjust dose of these. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Viekira Pak; monitor tacrolimus levels and renal function. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant voriconazole, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Concomitant atazanavir 300mg (without ritonavir): give only in the AM. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam.

Adverse Reactions:
Fatigue, nausea, pruritus, other skin reactions, insomnia, asthenia.

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

How Supplied:
Monthly carton—4 x 7 daily dose packs
http://www.hepatitisc.uw.edu/page/treatment/drugs/3d

美国FDA批准Viekira Pak方案治疗基因1型慢性丙型肝炎病毒
2014年12月19日，美国食品和药物监督管理局（FDA）批准了一种称为Viekira Pak （AbbVie）的联合口服药物用于治疗基因1型慢性丙型肝炎病毒（HCV）。
依据它的价格，Viekira Pak 可以给医师和患者一个较Gilead Sciences公司的sofosbuvir (Sovaldi)和ledipasvir/sofosbuvir (Harvoni)更为便宜的治疗选择。
相关机构公布，这一新的丙型肝炎治疗方案包括三个新的药物（ombitasvir，paritaprevir和dasabuvir），还有利托那韦，其中利托那韦可以大大提高paritaprevir的血液浓度。与ledipasvir/ sofosbuvir类似，Viekira Pak不需要使用会带来严重不良反应的干扰素，而是否添加利巴韦林是可以选择的。Sofosbuvir需要与干扰素和利巴韦林联合治疗基因1型和4型HCV，与利巴韦林联合仅用于基因2型和3型HCV。
“这个新一代HCV疗法正在改变美国HCV感染者的治疗标准，”FDA药品评价和研究中心抗菌产品办公室主任Edward Cox在新闻发布会上说。“我们继续看到，与一些老的以干扰素为基础的药物治疗方案相比，这些新的全口服药物治疗方案具有非常高的病毒学应答率和改善的安全属性。”Viekira Pak的适应症为慢性基因1型HCV患者，无论他们是否有肝硬化。
Sofosbuvir的过高价格—一个12周的疗程需花费84000美元--已经激怒了医疗保健行业。上周，宾夕法尼亚州费城的交通运输管理局，提起联邦集体诉讼反对Gilead Sciences公司的“高昂”的药品价格。Ledipasvir/sofosbuvir甚至更贵，估计一疗程94500美元。
今年初秋，北美最大的药房福利管理公司快捷药方公司（Express Scripts）表示，如果这一最新的HCV治疗方案更便宜且同样有效，他们可能会修改其处方集，以使Viekira Pak的受青睐程度超过sofosbuvir和ledipasvir/sofosbuvir。
当被问及AbbVie将以什么样的价格销售Viekira Pak，或价格是否会大幅低于sofosbuvir和ledipasvir/sofosbuvir，AbbVie公司发言人Morry Smulevitz告诉 Medscape Medical News，AbbVie目前正在起草一份官方声明，将在近期通过新闻专线发布。
基于包含2308例慢性HCV患者（其中一些有肝硬化）的6项临床试验的结果，FDA确定了Viekira Pak的疗效。这些试验的目的是测量是否治疗结束至少12周患者血液中不再检测到HCV，意味着治愈。根据研究，参与者被随机分配接受Viekira Pak或糖丸，Viekira Pak±利巴韦林，或新的药物联合利巴韦林治疗12周或24周。各组治愈率介于91％至100％。
疲劳、痒、浑身无力或精力贫乏、恶心、睡眠问题是在临床试验中报告的最常见的不良事件。欧洲药品监管部门于十一月推荐批准Viekira Pak方案。