2016年7月29日，美国FDA批准丙型肝炎产品dasabuvir, ombitasvir, paritaprevir and ritonavir(商标名 VIEKIRA XR 艾伯维（AbbVie）)缓释片的新药上市。
  VIEKIRA XR是每日一次的缓释制剂，与先前获批产品VIEKIRA PAK一样，有效成分是dasabuvir、ombitasvir、paritaprevir和ritonavir，用于治疗基因1型的慢性丙型肝炎病毒成人感染者。他们包括伴有代偿性肝硬化的患者，但不包括那些晚期肝硬化伴有失代偿性肝硬化的丙肝患者。
  丙型肝炎是一种由于丙型肝炎病毒感染而引起的肝脏炎症疾病，它可导致肝功能下降、肝衰竭甚至肝癌。据美国CDC统计，大约有270万美国人感染有丙型肝炎病毒。根据世界卫生组织的数据，全球估计有1.7亿人患有慢性丙型肝炎，每年有大约有50万人死于与丙肝相关的肝脏疾病。大多数感染有丙型肝炎病毒的人在肝脏损伤变得明显之前没有疾病症状，如果不进行正常治疗，这一感染过程在20到30年后，其中有10-20%的患者个体会发展为肝硬化和肝癌。目前，尚无预防丙型肝炎病毒感染的疫苗。
  丙肝病毒有六种不同的基因型，不同的基因型对药物反应也不同。其中1型是最常见的丙肝亚型，约占60%。以往丙肝的治疗方法以干扰素和利巴韦林（Ribavirin）为基础，需要每周静脉注射，经48周疗程后，治愈率仍只有50％左右。
  FDA对Viekira XR的批准是基于七个3期临床试验的良好数据，2300多名患者接受Viekira XR治疗后有非常高的治愈率。同时，Viekira XR也通过了与Viekira XR比较的两项生物制剂等效性试验。
  Viekira XR的成分被临床试验数据证明针对基因1b型患者有100％的治愈率，Viekira XR获批为1型丙肝患者提供了一项全新的治疗方案。
  VIEKIRA XR推剂量；VIEKIRA XR是一个由200毫克dasabuvir、8.33毫克ombitasvir、50毫克paritaprevir和33.33毫克ritonavir组合的缓释片剂，。Viekira每日服用一次，每次服用三片，必须与食物一起服用.

研究资料附件：https://www.viekira.com/hcp?cid=GHCV16VKHCPRD1
VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets
VIEKIRA XR Rx
Generic Name and Formulations:
Dasabuvir, ombitasvir, paritaprevir, ritonavir; 200mg/8.33mg/50mg/33.33mg; ext-rel tabs.
Company:
AbbVie
Select therapeutic use: Viral infections
Indications for VIEKIRA XR :
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. Swallow whole. Take with a meal. ≥18yrs: 3 tabs once daily. 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.
Pharmacological Class:
HCV NS5B palm polymerase inhibitor/HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A 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