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FDA批准VIEKIRA XR缓释片为首个丙肝一日一次新型缓释剂

2016-11-16 03:08:21 作者：新特药房来源：互联网浏览次数：0 文字大小：【大】【中】【小】

简介： 近日，生物制药公司艾伯维（AbbVie）宣布，美国FDA已经批准了其产品VIEKIRA XR缓释片的新药申请（NDA）。 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、ombi ...

关键字：dasabuvir、ombitasvir、paritaprevir和ritonavir商品名VIEKIRA XR 用于治疗基因1型的慢性丙型肝炎

近日，生物制药公司艾伯维（AbbVie）宣布，美国FDA已经批准了其产品VIEKIRA XR缓释片的新药申请（NDA）。 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。

获批产品VIEKIRA PAK（图片来源：AbbVie）
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。

感染丙肝病毒后恶化过程（图片来源：University of Washington）

丙肝病毒在体内的繁殖过程（图片来源：Nature Reviews）
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。

电镜下的丙肝病毒颗粒（图片来源：NIH）
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，每日一次给药三粒，必须与食物一起服用。
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 PAK治疗后有非常高的治愈率。同时，VIEKIRA XR也通过了与VIEKIRA PAK比较的两项生物制剂等效性试验。

丙肝病毒及肝硬化治疗研究的历史里程碑（图片来源：Nature Reviews）
艾伯维的副总裁兼首席医疗官Rob Scott博士说道：“艾伯维致力于继续推动丙型肝炎的治疗护理，这是我们对患者持续承诺的积极表现。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的新药申请获批为1型丙肝患者提供了新的治疗选择方案。”
参考资料
[1] AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR?（dasabuvir, ombitasvir, paritaprevir and ritonavir） for the Treatment of Genotype 1 Chronic Hepatitis C
[2] FDA Green Lights AbbVie （ABBV） Once-Daily Viekira XR for Hepatitis C
[3] Centers for Disease Control and Prevention （CDC）。 Hepatitis C FAQs for health professionals.
[4] AbbVie 官方网站：
1）：https://www.viekira.com/
2）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b42e05f-33dd-49a0-ae24-a316f07a4b8d
VIEKIRA XR (Lorcaserin Hydrochloride Extended-Release Tablet)
About VIEKIRA XR
VIEKIRA XR is a prescription medicine that is taken once a day with a meal.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA XR in combination with ribavirin, you should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information I should know about VIEKIRA XR?
•VIEKIRA XR may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
•VIEKIRA XR can cause increases in your liver function blood test results, especially if you use ethinyl estradiol-containing medicines (such as some birth control products).
You must stop using ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) before you start treatment with VIEKIRA XR. If you use these medicines as a method of birth control, you must use another method during treatment with VIEKIRA XR, and for about 2 weeks after you finish treatment with VIEKIRA XR. Your doctor will tell you when you may begin taking ethinyl estradiol-containing medicines.
•Your doctor should do blood tests to check your liver function during the first 4 weeks of treatment and then as needed.
•Your doctor may tell you to stop taking VIEKIRA XR if you develop signs or symptoms of liver problems. Tell your doctor right away if you develop any of the following symptoms, or if they worsen during treatment with VIEKIRA XR: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, color changes in stools, confusion, or swelling of the stomach area.
Do not take VIEKIRA XR if you:
•have certain liver problems
•take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, TEGRETOL®-XR, TERIL®) • cisapride (Propulsid®) • colchicine (Colcrys®), in patients who have certain kidney or liver problems • dronedarone (Multaq®) • efavirenz (Atripla®, Sustiva®) • ergot-containing medicines, including ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • lurasidone (Latuda®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • ranolazine (Ranexa®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Simcor®, Vytorin®, Zocor®) • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort • triazolam (Halcion®)
•have had a severe skin rash after taking ritonavir (Norvir®)
What should I tell my doctor before taking VIEKIRA XR?
•If you have: liver problems other than hep C infection, HIV infection, or any other medical conditions.
•If you have had a liver transplant. If you take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), your doctor should check your blood levels and, if needed, may change your dose of these medicines or how often you take them, both during and after treatment with VIEKIRA XR.
•If you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. It is not known if VIEKIRA XR will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take VIEKIRA XR.
•About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA XR.
Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take VIEKIRA XR with other medicines.
When you are finished with VIEKIRA XR, ask your doctor what to do if you had a change in dose or stopped one of your usual medicines during VIEKIRA XR treatment.
What are the common side effects of VIEKIRA XR?
•For VIEKIRA XR used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
•For VIEKIRA XR used without ribavirin, side effects include nausea, itching, and sleep problems.
These are not all of the possible side effects of VIEKIRA XR. Tell your doctor if you have any side effect that bothers you or that does not go away.
This is the most important information to know about VIEKIRA XR. For more information, talk to your doctor or healthcare provider.
USE
VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release 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.
VIEKIRA XR can be used in people who have compensated cirrhosis.
VIEKIRA XR is not for people with advanced cirrhosis (decompensated). If you have cirrhosis, talk to your doctor before taking VIEKIRA XR.