Generic Name: dasabuvir and ombitasvir and paritaprevir and ritonavir
Dosage Form: tablets
VIEKIRA PAK Rx
Pharmacological Class:
HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A inhibitor + HCV non-nucleoside NS5B palm polymerase inhibitor.

Active Ingredient(s):
Ombitasvir/paritaprevir/ritonavir; 12.5mg/75mg/50mg; with dasabuvir 250mg; tablets.

Company
AbbVie
Indication(s):
Chronic hepatitis C virus (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.

Pharmacology:
Ombitasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. Paritaprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein and is essential for viral replication. Ritonavir increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure. Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.

Legal Classification:
Rx

Adults:
Take with a meal. ≥18 years: 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:
<18 years: not established.

Contraindication(s):
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 Category 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 (Category B). Use progestin-only contraception or non-hormonal methods, if necessary. Nursing mothers.

Interaction(s)
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 Reaction(s)
Fatigue, nausea, pruritus, other skin reactions, insomnia, asthenia.

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

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

LAST UPDATED:
3/9/2015

FDA批准Viekira Pak方案治疗丙型肝炎
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。