2014年12月19日，美国食品药品监督管理局（以下简称FDA）批准Viekira Pak（ombitasvir+ paritaprevir+ritonavir片剂联合dasabuvir片剂）用于治疗基因1型慢性丙型肝炎病毒（HCV）感染者，包括合并肝硬化的患者。
  丙肝是一种引起肝脏炎症的病毒性疾病，可导致肝功能下降、肝功能衰竭或肝癌。大多感染丙肝病毒的患者在出现明显肝损害前没有任何症状，这一潜伏期可达数十年。据美国疾病控制与预防中心（CDC）的数据显示，美国约有320万人感染HCV，如果得不到适当治疗，其中将有15%～30%的感染者会发展成肝硬化。
  Viekira Pak包含三种新药——ombitasvir、paritaprevir和dasabuvir，这三种药物可协同抑制丙肝病毒的生长。Viekira Pak还包含了之前获批用于增加血中paritaprevir浓度的药物—ritonavir。Viekira Pak可以和利巴韦林联合使用，也可以单独使用，但是不推荐失代偿期肝硬化的患者使用。
  新一代的丙肝病毒治疗学正在改变美国丙肝患者的治疗模式，”FDA药物评价和研究中心抗菌产品办公室主任Edward Cox博士说。“我们看到口服新药的持续发展，相比以干扰素为基础的老一代治疗方案，这些新药不仅有非常高的病毒学应答率，而且更加安全。”
  Viekira Pak是在过去一年里获得FDA批准、用于治疗慢性HCV感染的第四个药物。FDA于2013年11月批准了Olysio（simeprevir），于2013年12月批准了Sovaldi（索菲布韦），于2014年10月批准了Harvoni（来地帕韦+索菲布韦）。
  Viekira Pak的有效性在六个临床实验中得到评估，这些试验总共入组了2308名受试者，他们是患有肝硬化和无肝硬化的慢性HCV感染者。
  在不同的试验中，受试者随机接受Viekira Pak治疗或安慰剂（糖衣药片）治疗；Viekira Pak联合或不联合利巴韦林治疗； Viekira Pak联合利巴韦林治疗12周或24周。这些试验旨在确定，受试者在治疗结束至少12周后血液中是否还能检测到丙肝病毒（持续病毒学应答，或SVR），SVR用以表明患者的丙肝已经治愈。包括难治性患者在内的多种受试者群体的试验结果显示，在接受Viekira Pak推荐剂量治疗的受试者中，有91%～100%的受试者实现了持续病毒学应答。
  Viekira Pak最常见的副作用是疲惫、瘙痒、虚弱无力或缺乏活力、恶心和睡眠困难。
  Viekira Pak的推荐剂量是12.5mg ombitasvir+75mg paritaprevir+50mg ritonavir片剂，一天一次，一次2片；和250mg dasabuvir片剂，一天两次，一次1片。

译自：http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf

Viekira Pak(Ombitasvir, Paritaprevir, and Ritonavir tablets; Dasabuvir Tablets)
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 1a (in combination with ribavirin) or 1b infection without cirrhosis or with compensated cirrhosis.
Adult:
Test for HBV infection prior to initiation. 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: treat for 12 weeks + ribavirin. Genotype 1a with compensated cirrhosis (Child-Pugh A): treat for 24 weeks + ribavirin (based on prior treatment history, 12 weeks treatment may be considered for some patients). Genotype 1b with or without compensated cirrhosis (Child-Pugh A): 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.
Contraindications:
Moderate-to-severe hepatic impairment. Concomitant alfuzosin, ranolazine, dronedarone, colchicine (in renal and/or hepatic impairment), carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, lurasidone, pimozide, ergot derivatives, ethinyl estradiol, cisapride, St. John’s Wort, atorvastatin, lovastatin, simvastatin, everolimus, sirolimus, tacrolimus, 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:
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Risk of hepatic decompensation and hepatic failure in patients with cirrhosis; assess for evidence or signs/symptoms prior to initiation; discontinue if occurs. Perform hepatic lab tests at baseline, 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. Pregnancy. Use progestin-only contraception or non-hormonal methods, if necessary. Nursing mothers.
Interactions:
See Contraindications. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. 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 ⅕ of current dose and monitor renal function), acetaminophen/hydrocodone (reduce dose by 50% and monitor). Potentiates ARBs (eg, valsartan, losartan, candesartan), CCBs (eg, amlodipine, nifedipine, diltiazem, verapamil); reduce dose of these (amlodipine by at least 50%) and monitor; consider alternatives if adverse effects occur. Concomitant quetiapine: consider alternative anti-HCV therapy; if necessary, reduce quetiapine to ⅙ of current dose and monitor. Concomitant calcineurin inhibitors (in liver transplant): adjust dose of these. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant voriconazole, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol, metformin (in renal or hepatic impairment): not recommended. Concomitant atazanavir 300mg (without ritonavir): give only in the AM. Antagonizes carisoprodol, cyclobenzaprine, diazepam; increase dose if needed. May antagonize omeprazole; consider increasing omeprazole dose: max 40mg/day. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor with furosemide, buprenorphine/naloxone, alprazolam. For Viekira XR: avoid alcohol for 4hrs after dose. Monitor INR with warfarin.
See Also:
VIEKIRA XR
Pharmacological Class:
HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A inhibitor + HCV NS5B palm polymerase inhibitor.
Adverse Reactions:
Fatigue, nausea, pruritus, other skin reactions, insomnia, asthenia.
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