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波普瑞韦胶囊

新药编辑:新特药 更新时间:2015-02-04

  英文药名:VICTRELIS(Boceprevir)capsules
  中文药名:波普瑞韦胶囊 伯赛匹韦
  药品信息
  美FDA批准Victrelis是默克制药公司研制的用于治疗基因1型丙型肝炎的新药
  5月13日,美国食品和药物管理局(FDA)首次批准了新一代丙型肝炎治疗药物Victrelis上市。Victrelis是默克制药公司研制的用于治疗基因1型丙型肝炎的新药。临床试验数据显示,当这种药物与现在药物共同使用时,能有效治愈60%以上的患者,比较而言,单独使用现有药物的治愈率在20%至40%之间;而且,新药在提高治愈率的同时还能缩短治疗时间。
  FDA隶属美国健康和人类服务署,是美国最早以保护消费者利益为主要职能的联邦机构之一。FDA药物评估和研究中心抗菌药品办公室主任爱德华·卡克斯表示:“对丙型肝炎患者来说,Victrelis是一个重要的进步。这种新药为一种严重疾病提供了有效的治疗方法,与现有可获得的治疗方法相比,为部分丙型肝炎患者提供了一个更好的治疗机会。”
  圣路易斯大学医学院内科学教授、Victrelis临床试验的研究人员布鲁斯·培根博士说:“对医生和患者来说,这是激动人心的一天,因为Victrelis是最近十年中慢性丙型肝炎治疗的第一个重大进展。与目前使用的标准治疗方法相比,Victrelis明显提高了患者达到无病毒查出水平的机会。对许多患者来说,Victrelis能缩短其治疗时间。”
  Victrelis也被称为boceprevir,是一种新型的丙型肝炎病毒蛋白毒抑制剂。丙型肝炎病毒蛋白毒是病毒复制所需要的。通过抑制这种病毒酶从而阻止病毒的复制,Victrelis借用了HIV治疗中的成功战略。
  《纽约时报》的文章指出,在默克公司的Victrelis获FDA批准使用之际,美国福泰(Vertex)制药公司研制的丙肝蛋白酶抑制剂telaprevir也有望在今年5月获FDA批准,一场激烈的市场竞争即将开始。
  基于临床试验的结果,分析家们普遍认为,福泰新药在市场上的销量可能会超过默克。这两种新药在4月都接到了FDA顾问委员会的匿名建议。许多公司也不甘落后,从而让丙肝的治疗成为制药业最热的领域之一。
  纽约西奈山医学院首席肝病专家斯科特·弗里德曼博士说:“即使不考虑这种药物的最终成功,这也是丙型肝炎治疗领域一个伟大时代来临的前兆。”
  美国疾病控制和预防中心的数据显示,美国有320万慢性丙型肝炎患者,基因1型丙型肝炎占其中的70%。丙肝病毒能引发肝脏炎症,导致肝脏功能的减少甚至肝功能衰竭。绝大多数肝炎患者最初并没有疾病症状,直到几十年或几年后肝脏功能损伤出现,而在此之前他们并不知道自己被感染的事实。
  在美国实施的肝脏移植手术主要是由丙肝病毒感染引发的进展性肝脏疾病。在感染丙型肝炎病毒之后,许多人会发展成慢性丙型肝炎,部分人在多年后会发展为肝硬化,肝硬化会导致综合性的肝损伤,如出血、黄疸、白蛋白聚集在腹部引起的腹水、感染或肝癌。
  人们感染丙肝的方式有多种途径,包括暴露于感染丙肝病毒的血液、出生时因母亲携带丙肝病毒而被感染、共用针头、与感染者发生性行为、与感染者共用剃刀、牙刷等,或者使用未经消毒的纹身或穿孔工具。
  慢性丙型肝炎现有的治疗方法需要在近1年的时间里每周注射长效α-干扰素,同时每天服用病毒唑药丸。这种生活方式非常痛苦,药物的副作用包括流感症状、抑郁和贫血,而且目前也不完全清楚这些药物的作用原理。
  在治疗中,默克新药Victrelis和福泰新药telaprevir必须和现有药物共同使用,科学家们希望在未来几年内,能将3种或4种新药整合为一种药物,而且不再需要注射α-干扰素药物。
  临床试验数据显示,默克和福泰的新药能在更短的治疗期内清除部分患者体内的病毒。在默克的临床试验中,44%以前未接受过治疗的患者能在28周的时间完成治疗,而不是通常所需要的48周。
  这种新药也有副作用。在默克公司的临床试验中,大约50%的患者在服用Victrelis后出现了贫血症状,这个比例是只使用现有药物患者的2倍;服用Victrelis的患者发生白血细胞数量低的风险也更高。而且,患者需要服用大量的药片。Victrelis需要每天服用3次共12个胶囊。Ribavirin需要每天服用两次共5个或6个药片。如果患者没有按时按量服药,那么病毒可能会对这些药物形成抗性。
  默克公司将在FDA批准之日起一周内将Victrelis推向市场,公司为Victrelis制定的批发价格是每周1100美元,意味着治疗全程的费用为2.64万美元至4.84万美元。尽管治疗期需要28周至48周的时间,但在治疗的前4个星期并不需要Victrelis。

  批准日期: 2011年5月13日;公司:Merck
  VICTRELIS
  Generic Name and Formulations:
  Boceprevir 200mg; capsules.
  Company:
  Merck & Co., Inc.
  Indications for VICTRELIS:
  Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy including prior null responders, partial responders, and relapsers. Not for use as monotherapy.
  Adult Dose for VICTRELIS:
  ≥18yrs: Take with food. 800mg three times daily. Start after 4 weeks therapy with peginterferon and ribavirin. Without cirrhosis: continue treatment as indicated by HCV-RNA levels at Weeks 8, 12, and 24 (see full labeling). With cirrhosis: continue for 44 weeks. Do not reduce dose. Discontinue if HCV-RNA levels indicate futility (see full labeling).
  Children's Dose for VICTRELIS:
  <18yrs: not recommended.
  Pharmacological Class:
  HCV NS3/4A protease inhibitor.
  Contraindications:
  Concomitant potent CYP3A4/5 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) or narrow therapeutic index CYP3A4/5 substrates (eg, alfuzosin, cisapride, ergot derivatives, lovastatin, simvastatin, drosperinone, pimozide, sildenafil or tadalafil for PAH, triazolam, oral midazolam). Pregnant women and men whose partners are pregnant (note: ribavirin is Cat. X). Review peginterferon and ribavirin contraindications.
  Warnings/Precautions:
  Female patients and partners must have (–) pregnancy test before therapy, use appropriate effective contraception, and undergo monthly pregnancy test. Monitor CBC w. differential, HCV-RNA. If hgb <10g/dL: reduce or interrupt ribavirin; if hgb <8.5g/dL: discontinue ribavirin; if ribavirin permanently discontinued, then peg-interferon alfa and Victrelis must be discontinued. Co-infection with HBV or HIV. Decompensated cirrhosis. Organ transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.
  Interactions:
  See literature. Concomitant rifabutin, salmeterol, efavirenz, concomitant colchicine in renal or hepatic impairment: not recommended. Potentiates CYP3A4/5 substrates (eg, amiodarone, bepridil, propafenone, quinidine, flecainide, trazodone, desipramine, azole antifungals, clarithromycin). Antagonizes ethinyl estradiol. Antagonized by potent CYP3A4/5 inhibitors. Monitor warfarin, digoxin, dihydropyridine calcium channel blockers, bosentan, protease inhibitors, immunosuppressants, opioids. Concomitant ketoconazole, itraconazole: max 200mg/day. Concomitant atorvastatin: max 40mg/day. Colchicine, PDE5 inhibitors for ED (eg, sildenafil, tadalafil, vardenafil), alprazolam, IV midazolam: reduce doses and monitor. Corticosteroids: avoid, monitor if needed.
  Adverse Reactions:
  Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia; hypersensitivity reactions (discontinue if occurs).
  Metabolism:
  Hepatic.
  Elimination:
  Fecal (primarily), renal.
  Generic Availability:
  NO
  How Supplied:
  Bottles (12 caps/bottle)—28
  Generic Name: boceprevir
  Date of Approval: May 13, 2011
  Company: Merck
  Treatment for: Chronic Hepatitis C
  FDA Approves Victrelis
  The U.S. Food and Drug Administration (FDA) has approved Victrelis(boceprevir) for the treatment of chronic hepatitis C (CHC).
  Victrelis is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
  Victrelis Medication Guide
  Read this Medication Guide before you start taking Victrelis, and each time you get a refill. There may be important new information.
  This information does not take the place of talking with your doctor, nurse or physician assistant (healthcare provider) about your medical condition or your care.
  Victrelis is taken along with peginterferon alfa and ribavirin. You should also read those Medication Guides.
  Important information about Victrelis
  Victrelis, in combination with peginterferon alfa and ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Victrelis, peginterferon alfa, and ribavirin combination therapy and for 6 months after
  treatment is over.
  Females and males must use 2 forms of birth control during treatment and for 6 months after treatment with Victrelis, peginterferon alfa, and ribavirin. Hormonal forms of birth control, such as birth control pills, vaginal rings, implants and injections,
  may not work as well during treatment with Victrelis. You may get pregnant while using these birth control methods while on Victrelis.
  Talk to your healthcare provider about other forms of birth control that may be used during this time.
  Females must have a pregnancy test before starting treatment with Victrelis combination therapy, every month while being treated, and every month for 6 months after treatment with Victrelis, peginterferon alfa, and ribavirin is over.
  If you or your female sexual partner becomes pregnant while taking Victrelis, peginterferon alfa, and ribavirin or within 6 months after you stop taking these medicines, tell your healthcare provider right away. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
  Do not take Victrelis alone to treat chronic hepatitis C infection.
  Victrelis must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
  What is Victrelis?
  Victrelis is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults who have not been treated before or who have failed previous treatment.
  It is not known if Victrelis is safe and effective in children under 18 years of age.
  Who should not take Victrelis?
  See Important information about VictrelisDo not take Victrelis if you:
  take certain medicines. Victrelis may cause serious side effects when taken with certain medicines. Read the section Before taking Victrelis.
  Talk to your healthcare provider before taking Victrelis if you have any of the conditions listed below.
  Before taking Victrelis
  Before you take Victrelis, tell your healthcare provider if you:
  have certain blood disorders such as anemia (low red blood cell count).
  have liver problems other than hepatitis C infection.
  have human immunodeficiency virus (HIV) or any other immunity problems.
  have had an organ transplant.
  plan to have surgery.
  have any other medical condition.
  are breastfeeding. It is not known if Victrelis passes into breast milk. You and your healthcare provider should decide if you will take Victrelis or breastfeed. You should not do both.
  Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  Victrelis and other medicines may affect each other, causing side effects or affecting the way Victrelis and your other medicines work. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
  Do not take Victrelis if you take:
  alfuzosin hydrochloride (Uroxatral)
  anti-seizure medicines:
  carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR, Teril)
  phenobarbital
  phenytoin (Dilantin)
  cisapride (Propulsid)
  drosperinone-containing medicines, including:
  Yaz, Yasmin, Zarah, Ocella, Gianvi, Beyaz, Safyral
  ergot-containing medicines, including:
  dihydroergotamine mesylate (D.H.E. 45, Migranal)
  ergonovine and methylergonovine (Ergotrate, Methergine)
  ergotamine tartrate (Cafergot, Migergot, Ergomar, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
  lovastatin (Advicor, Altoprev, Mevacor)
  midazolam (Versed), when taken by mouth
  pimozide (Orap)
  rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  sildenafil (Revatio), when used for treating lung problems
  simvastatin (Simcor, Vytorin, Zocor)
  St. John's Wort (Hypericum perforatum) or products containing St.
  John's Wort
  tadalafil (Adcirca), when used for treating lung problems
  triazolam (Halcion)
  Tell your healthcare provider if you are taking or starting to take any of these medicines:
  clarithromycin (Biaxin, Biaxin XL, Prevpac)
  dexamethasone
  efavirenz (Sustiva, Atripla)
  ketoconazole (Nizoral)
  posaconazole (Noxafil)
  rifabutin (Mycobutin)
  ritonavir (Norvir, Kaletra)
  voriconazole (Vfend)
  Your healthcare provider may need to monitor your therapy more closely if you take Victrelis with the following medicines. Talk to your doctor if you are taking or starting to take these medicines:
  alprazolam (Xanax)
  amiodarone (Cordarone, Exterone, Pacerone)
  atorvastatin (Lipitor)
  bepridil (Vascor)
  bosentan (Tracleer)
  budesonide (Pulmicort, Pulmicort Flexihaler, Rhinocort, Pulmicort Respules, Symbicort)
  buprenorphine (Butrans, Buprenex, Suboxone, Subutex)
  cyclosporine (Gengraf, Neoral, Sandimmune)
  desipramine (Norpramin)
  digoxin (Lanoxin)
  felodipine (Plendil)
  flecainide (Tambocor)
  fluticasone (Veramyst, Flovent HFA, Flovent Diskus, Advair HFA, Advair Diskus)
  hormonal forms of birth control, including birth control pills, vaginal rings, implants and injections
  methadone (Dolophine)
  nifedipine (Procardia, Adalat CC, Procardia XL, Afeditab CR)
  nicardipine (Cardene SR, Cardene)
  propafenone (Rhythmol, Rhythmol SR)
  quinidine
  salmeterol (Advair HFA, Advair Diskus, Serevent)
  sirolimus (Rapamune)
  tacrolimus (Prograf)
  voriconazole (Vfend)
  colchicine (Colcrys, Probenecid and Colchicine, Col-Probenecid)
  trazadone (Desyrel)
  vardenafil (Staxyn, Levitra)
  warfarin (Coumarin)
  How should I take Victrelis?
  Take Victrelis exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to take and when to take it.
  Take Victrelis with food (a meal or light snack).
  Victrelis is packaged into single daily-use bottles. Each bottle has your entire day's worth of medicine. Make sure you are taking the correct amount of medicine each time.
  If you miss a dose of Victrelis and it is less than 2 hours before the next dose, the missed dose should be skipped.
  If you miss a dose of Victrelis and it is more than 2 hours before the next dose, take the missed dose with food. Take your next dose at your normal time and continue the normal dosing schedule. Do not double the next dose.
  If you have questions about what to do, call your healthcare provider.
  Your healthcare provider should do blood tests before you start treatment, at weeks 4, 8, 12, and 24, and at other times as needed during treatment, to see how well the medicines are working and to check for side effects.
  If you take too much Victrelis, call your healthcare provider or go to the nearest hospital emergency room right away.
  Victrelis side effects
  Victrelis may cause serious side effects, including:
  See Important information about Victrelis
  Blood problems. Victrelis can affect your bone marrow and cause low red blood cell, and low white blood cell, counts. In some people, these blood counts may fall to dangerously low levels. If your blood cell counts become very low, you can get anemia or infections.
  The most common side effects of Victrelis in combination with peginterferon alfa and ribavirin include:
  tiredness
  nausea
  headache
  change in taste
  Tell your healthcare provider about any side effect that bothers you or that does not go away.
  These are not all the possible side effects of Victrelis. For more information, ask your healthcare provider or pharmacist.
  How should I store Victrelis?
  Store Victrelis capsules in a refrigerator at 36°-46°F (2-8°C).
  Safely throw away refrigerated Victrelis after the expiration date.
  Victrelis capsules may also be stored at room temperature up to 77°F (25°C) for 3 months.
  Keep Victrelis in a tightly closed container and away from heat.
  Keep Victrelis and all medicines out of the reach of children.
  General Information About the Safe and Effective Use oF Victrelis
  Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  Do not use Victrelis for a condition for which it was not prescribed. Do not give Victrelis to other people, even if they have the same symptoms that you have. It may harm them.
  This Medication Guide summarizes the most important information about Victrelis. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Victrelis that is written for health professionals.
  What are the ingredients in Victrelis?
  Active ingredients: boceprevir
  Inactive ingredients: sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, and magnesium stearate.
  Red capsule shell: gelatin, titanium dioxide, D&C Yellow #10, FD&C
  Blue #1, FD&C Red #40.
  Yellow capsule shell: gelatin, titanium dioxide, D&C Yellow #10,
  FD&C Red #40, FD&C Yellow #6.
  Red printing ink: shellac, red iron oxide. Yellow printing ink:
  shellac, povidone, titanium dioxide, D&C Yellow #10 Aluminum Lake.

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