2011年5月13日，美国食品与药物管理局（FDA）发布公告，批准Victrelis（活性成分：boceprevir）与聚乙二醇干扰素α和利巴韦林联合使用，用于治疗仍有部分肝功能、且以前未使用药物治疗或治疗失败的丙型肝炎患者。 两项3期临床试验评估了Victrelis的安全性和有效性。有1500例成人患者被纳入研究。与只给予聚乙二醇干扰素和利巴韦林治疗的患者相比，接受Victrelis与聚乙二醇干扰素和利巴韦林联合治疗的患者中，有三分之二呈现显著提高的持续性病毒学应答（即在停止治疗后24周，血液中不再检出丙型肝炎病毒）。当患者结束治疗后维持病毒学反应，则表明丙型肝炎病毒感染已治愈。持续性病毒学反应可减少肝硬化和肝病并发症、降低肝癌（肝细胞癌）率、降低死亡率。 Victrelis药丸每日服用3次，于进餐时服用。 接受Victrelis与聚乙二醇干扰素和利巴韦林联合治疗的患者最常见的副作用包括疲劳、红细胞计数降低（贫血）、恶心、头痛和味觉障碍。 VICTRELIS™ (boceprevir)胶囊 美国初始批准：2011 优先审评药物 生产商：先灵葆雅公司 适应证和用途 VICTRELIS是一种丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制剂适用于与聚乙二醇干扰素α和利巴韦林[ribavirin]联用基因型1感染慢性丙型肝炎CHC)的治疗，在有代偿性肝病(≥18岁)成年患者，包括肝硬变，既往未治疗或既往干扰素和利巴韦林治疗已失败患者。 VICTRELIS必须作为单药治疗使用。 剂量和给药方法 800 mg 每天口服三次给药(每7-9小时)与食物(一餐或小吃). （1）VICTRELIS必须与聚乙二醇干扰素α和利巴韦林联用给药。 （2）为特殊给药指导参考聚乙二醇干扰素α和利巴韦林包装插件。 剂型和规格 胶囊：200 mg   禁忌证 （1）因为VICTRELIS必须与聚乙二醇干扰素α和利巴韦林给药，也应用对聚乙二醇干扰素α和利巴韦林所有禁忌证。 （2）因为利巴韦林可能致出生缺陷和胎儿死亡，妊娠妇女中和女性伴侣妊娠男性禁忌boceprevir与聚乙二醇干扰素α和利巴韦林联用。 （3）与高度依赖CYP3A4/5清除的药物共同给药，和因为升高血浆浓度伴随严重和/或危及生命事件。 （4）强CYP3A4/5诱导剂where显著减低boceprevir血浆浓度可能伴随减低疗效。 警告和注意事项 VICTRELIS与利巴韦林和聚乙二醇干扰素α使用： （1）利巴韦林可能致出生缺陷和胎儿死亡：在女性患者和男性患者的女性伴侣中避免妊娠。治疗前患者必须有妊娠检验阴性；使用两种或更多方式避孕，和每月妊娠检验。 （2）贫血 –VICTRELIS增添至聚乙二醇干扰素α和利巴韦林与单独聚乙二醇干扰素α和利巴韦林比较是伴随另外的血红蛋白浓度减低。 （3）中性粒细胞减少 - VICTRELIS增添至聚乙二醇干扰素α和利巴韦林可能导致伴随单独聚乙二醇干扰素α和利巴韦林治疗中性粒细胞减少恶化。 不良反应 在临床试验中接受VICTRELIS与PegIntron和REBETOL联用成年受试者中最常报道的不良反应(大于35%受试者)是疲乏，贫血，恶心，头痛和味觉障碍。 药物相互作用 （1）VICTRELIS是一种CYP3A4/5强抑制剂和部分被CYP3A4/5代谢。治疗前和期间必须考虑药物-药物相互作用潜在可能。 特殊人群中使用 （1）肝硬变：尚未在有代偿肝硬变患者或有一种器官移植患者中研究安全性和疗效。 （2）与人类免疫缺陷病毒(HIV)合并感染：尚未确定有HCV和HIV合并感染患者中安全性和疗效。 （3）与乙型肝炎病毒(HBV)合并感染：尚未有HCV和HBV合并感染患者中研究安全性和疗效。 （4）儿童：尚未在儿童患者中研究安全性和疗效。 （5）可得到利巴韦林妊娠注册。 如何供应/贮存和处置 如何供应 VICTRELIS 200 mg胶囊由红色帽与黄墨水印Merck标志，和黄色体部用红墨水印有“314” 组成。胶囊被包装在有28含12胶囊瓶的纸箱(NDC 0085-0314-02). 贮藏和处置 VICTRELIS 胶囊应贮存在冰箱2-8°C(36-46°F)直至发放。避免暴露于过热。对使用患者，冰箱贮存VICTRELIS胶囊可保持稳定至标签上失效期。VICTRELIS也可贮存在室温至25°C(77°F) 3个月。保持容器密闭。 日期：05/2011 Manufacturer: Schering Corporation Description: 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. Side Effects: Victrelis may cause serious side effects, including: 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. A new medicine “Boceprevir”  (Victrelis) has been approved by FDA for the treatment of chronic Hepatitis-C in adults. Patients whose liver function is still working and who have not taken any Hepatitis-C medication earlier or who have failed such treatment are able to get benefits from Boceprevir. Boceprevir with the name of “Victrelis” developed by Schering Plough (now being developed by Merck due to the merger of these companies) is approved for the treatment in combination with peginterferon alfa and ribavirin. (Peg interferon alfa is a pegylated intereferon i.e. made up of interferon protected with polyethylene glycol i.e. PEG and is used for the treatment of Hepatitis-C and ribavirin is an antiviral drug used for the treatment of Hepatitis-C infection in conjunction with peg interferon alfa). After test on 1500 adult patients, it was found that Victrelis (Boceprevir), along with peginterferon alfa and ribavirin, was able to sustain blood free of Hepatitis-C virus (i.e. sustained virologic response) for 24 weeks even after stoppage of treatment and this clearly indicates that Hepatitis-C infection has totally been eradicated. Sustained virologic response helps in decreased complications of liver disease, cirrhosis, liver cancer and mortality. This drug is effective for a large number of people with Hepatitis-C virus (HCV) as this virus silently causes infection of the liver and the person knows about the complication when a large portion of liver have already been damaged i.e. Hepatitis-C become chronic. Victrelis belongs to a class of Protease inhibitors which prevents the multiplication of virus after binding with it. Victrelis is a pill taken three times a day with food. Side effects after Victrelis combination treatment is anemia (low blood cell count), fatigue, headache, nausea and taste disturbance. ----------------------------------------------------------------------------- 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. 规格：VICTRELIS 200毫克/胶囊 12胶囊/瓶 28瓶/盒