英文药名：Victrelis（Boceprevir）

中文药名：波普瑞韦胶囊

品牌药生产：SCHERING

药品介绍：

美国食品和药品管理局（FDA）批准其慢性丙型肝炎（CHC）治疗创新新药Boceprevir（商品名Victrelis）上市。Victrelis获准与长效干扰素派罗欣（通用名聚乙二醇干扰素α）和利巴韦林联用治疗CHC基因I型慢性丙肝感染，适用于患有代偿性肝脏疾病（包括肝硬化）的18岁及以上的成年患者，这些患者以前未经治疗或之前用干扰素和利巴韦林治疗失败。

Victrelis不可用作单药治疗，只能与长效干扰素和利巴韦林联用。还没有研究Victrelis对之前用包括Victrelis或其他HCV NS3/4A蛋白酶抑制剂在内的治疗方案失败患者的疗效。

对于病历记载之前使用长效干扰素和利巴韦林联合治疗病史上无响应（截止治疗第12周，HCV-RNA下降不到2 log）的患者，Victrelis与长效干扰素和利巴韦林联用的疗效还未作研究。临床研究包括了对干扰素响应很差的患者。只用长效干扰素和利巴韦林联合治疗4周后病毒载量HCV-RNA下降不到0.5 log的患者，预计将会对用长效干扰素和利巴韦林联合治疗无响应（截止治疗第12周，HCV-RNA下降不到2 log）。

与对长效干扰素和利巴韦林联用响应较好的患者相比，干扰素响应不佳的患者接受Victrelis与长效干扰素和利巴韦林联合治疗后，出现持续病毒学应答（SVR）的可能性较低，而在治疗失败后耐药相关替代治疗的检出率却较高。

Victrelis为首个获准与长效干扰素和利巴韦林联用治疗慢性丙肝的新型丙肝病毒（HCV）蛋白酶抑制剂。长效干扰素和利巴韦林是现行慢性丙肝的标准疗法。 这是在十年内获批的首个慢性丙肝疗法。与目前的标准治疗相比，Victrelis可显著提高病人实现病毒水平不可检测的机会，从而获得SVR。对于许多患者，Victrelis可以使治疗的总持续时间缩短。

VICTRELIS

Generic Name for VICTRELIS

Boceprevir 200mg; capsules.

Legal Classification:

Rx

Pharmacological Class for VICTRELIS

HCV NS3/4A protease inhibitor.

Manufacturer of VICTRELIS

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. 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 literature). With cirrhosis: continue for 44 weeks. Do not reduce dose. Discontinue if HCV-RNA levels indicate futility (see literature).

Children's dosing for VICTRELIS

<18yrs: not recommended.

Contraindications for VICTRELIS

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 for VICTRELIS

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. Co-infection with HBV or HIV. Decompensated cirrhosis. Organ transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions for VICTRELIS

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 20mg/day. Colchicine, PDE5 inhibitors for ED (eg, sildenafil, tadalafil, vardenafil), alprazolam, IV midazolam: reduce doses and monitor. Corticosteroids: avoid, monitor if needed.

Adverse Reactions for VICTRELIS

Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia.

How is VICTRELIS supplied?

Bottles (12 caps/bottle)—28

Related Disease:

Hepatitis C

Hepatitis~antivirals

丙肝药物Victrelis(boceprevir)获欧盟认证

默克公司当日宣称，丙型肝炎治疗药物Victrelis(boceprevir)已获得欧盟认证。
Boceprevir是首个获欧洲药品管理局（EMA）批准的抗丙型肝炎病毒药物，是一种新型丙型肝炎病毒蛋白酶抑制剂，在美国被批准与聚乙二醇干扰素α和利巴韦林联用，治疗未经治疗或治疗无效的代偿期肝病（含肝硬化）成人患者。

EMA的决定基于欧盟和美国进行的两个大型的Victrelis(boceprevir) III期临床研究结果，该研究共招募1,500名1型慢性丙型肝炎病毒患者，旨在评价Victrelis(boceprevir) 的疗效和安全性。

MSD’s Victrelis (boceprevir) has been launched in the UK for the treatment of chronic hepatitis C (CHC) genotype 1 infection.

Victrelis is the first licensed drug to target the virus directly after its assessment was fast-tracked by the EMA.

Dr Ashley Brown, Consultant Hepatologist of St Mary's & Hammersmith Hospitals, says the drug offers “new hope for those in whom previous treatment has been unsuccessful”.

Approximately 250,000 people in the UK are chronically infected with hepatitis C – many of whom are unaware they are infected and consequently diagnosis is delayed.

Clinical trials found that in patients who had failed previous treatment, the addition of Victrelis almost tripled the number of those in which the virus had cleared.

In previously untreated patients, the addition of Victrelis nearly doubled those in which the virus had cleared compared to standard therapy alone.

Hepatitis C can lead to an inflammation of the liver and subsequent fibrosis (scarring) of the liver tissue. Ultimately, it can cause significant liver damage, including cirrhosis and liver cancer.
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原产地英文商品名:
VICTRELIS 200mg/cap 12caps/bottle 28bottles/box
原产地英文药品名:
BOCEPREVIR
中文参考商品译名:
VICTRELIS 200毫克/胶囊 12胶囊/瓶 28瓶/盒
中文参考药品译名:
BOCEPREVIR
生产厂家中文参考译名:
先灵
生产厂家英文名:
SCHERING