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Epclusa(sofosbuvir/velpatasvir)复方口服片

2016-07-06 09:12:47  作者:新特药房  来源:互联网  浏览次数:18  文字大小:【】【】【
简介: 近日,美国FDA批准Epclusa 用于治疗慢性丙型肝炎病毒感染成年患者,不管患者是否伴有肝硬化(晚期肝病)。对于中重度肝硬化(代偿失调性肝硬化)患者,Epclusa获批与利巴韦林合并使用。Epclusa是一款固 ...

近日,美国FDA批准Epclusa 用于治疗慢性丙型肝炎病毒感染成年患者,不管患者是否伴有肝硬化(晚期肝病)。对于中重度肝硬化(代偿失调性肝硬化)患者,Epclusa获批与利巴韦林合并使用。
Epclusa是一款固定剂量的复方药片,其含有索非布韦和Velpatasvir,前者于2013年获得批准,后者是一款新药,该复方药物是首款获批用于治疗所有6 种主要丙型肝炎病毒的药物。
此次批准为更广泛的慢性丙型肝炎病毒感染患者提供了一种管理及治疗选择,FDA药物评价与研究中心抗微生物产品办公室主任、医学博士Cox称。
丙型肝炎是一种病毒性疾病,它可引起肝脏炎症,导致肝功能衰退或肝衰竭。至少有6种不同的丙型肝炎病毒基因型(或病毒珠),从基因方面来讲它们属于不同种类的病毒。确定基因型有助于明确治疗的建议和治疗周期。
美国大约75%的慢性丙型肝炎患者为基因型1疾病,20%-25%的患者为基因型2或3疾病,少量患者感染有基因型4、5或6病毒。据美国疾病控制与预防中心提供的信息,慢性丙型肝炎病毒感染在大约75%-85%的病例中为慢性疾病。
多年以来,遭受慢性丙型肝炎病毒感染的患者有并发症,如出血、黄疸(眼或皮肤发黄)、腹部积液、感染、肝癌或死亡。
Epclusa 12周治疗的安全性及有效性在三项3期临床试验中得到评价,试验受试者为 1558 名没有肝硬化或有补偿性肝硬化(中度肝硬化)的患者。
结果证明,95%-99%的Epclusa治疗患者在完成12周治疗后其血液中检测不到病毒,这表明患者的感染已得到治愈。
批准日期:2016年6月28日;公司:Gilead Sciences,Inc.
EPCLUSA®索非布韦 sofosbuvir和velpatasvir)片,为口服使用
美国初次批准:
2016
作用机制
EPCLUSA是对丙型肝炎病毒直接作用抗病毒药索非布韦和velpatasvir固定-剂量组合[见微生物学]。
适应证和用途
EPCLUSA是索非布韦,一个丙型肝炎病毒(HCV)NS5B聚合酶抑制剂核苷酸类似物,和velpatasvir,一种HCV NS5A抑制剂的一个固定-剂量剂量组合,和适用为有慢性HCV基因型 1,2,3,4,5或6感染成年患者的治疗:
⑴无硬化或有代偿的硬化
⑵为与利巴韦林为有失代偿硬化联合使用
剂量和给药方法
推荐的剂量:一片(索非布韦400 mg和velpatasvir 100 mg)口服使用每天1次有或无食物(2.1)
见在以下表有基因型 1,2,3,4,5,或6 HCV患者推荐的治疗方案和时间:


不能对有严重肾受损或肾病终末期患者做剂量推荐。
剂型和规格
片:400mg索非布韦和100 mg velpatasvir
禁忌证
对利巴韦林禁忌患者中禁忌EPCLUSA和利巴韦林联合方案
警告和注意事项
用胺碘酮[amiodarone]共同给药心动过缓:在用胺碘酮患者,特别是在还接受β阻滞剂,或那些患心并发症和/或晚期肝病患者可能发生严重症状性心动过缓。建议胺碘酮不与EPCLUSA共同给药。In患者无另外可变治疗选择,建议心脏监视。
不良反应
⑴用EPCLUSA共12周,用治疗观察到最常见不良反应(发生率大于或等于10%,所有级别) 是头痛和疲乏。
⑵用EPCLUSA和利巴韦林治疗共12周在有失代偿硬化患者观察到最常见不良反应(发生率大于或等于10%,所有级别) 是疲乏,贫血,恶心,头痛,失眠和腹泻。
药物相互作用
⑴P-gp诱导剂和/或中度至强效CYP诱导剂(如,利福平[rifampin]圣约翰草[St. John’s wort],卡马西平[carbamazepine]):可能减低索非布韦和/或velpatasvir的浓度。建议不EPCLUSA不⑵与P-gp诱导剂和/或中度至强效使用。
使用前对潜在药物相互作用咨询完整处方资料。
供应/贮存和处置
各EPCLUSA片含400mg索非布韦和100mg的velpatasvir,为粉色,菱形,膜包衣,一侧凹陷有“GSI”和另一侧“7916”。各瓶含28片(NDC 61958-2201-1),聚酯卷材,和用防儿童开启封闭闭合。
贮藏在30 °C(86 ºF)以下。仅在原始容器内分发。


EPCLUSA(sofosbuvir 400 mg/velpatasvir 100 mg)-Sofosbuvir/GS-5816
U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
Epclusa is the First and Only All-Oral, Pan-genotypic Single Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead’s Third Sofosbuvir-Based Regimen
U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.  Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin.  Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).
IMPORTANT SAFETY INFORMATION
Contraindications
If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.
Adverse Reactions
The most common adverse reactions (≥10%, all grades) with EPCLUSA were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
Drug Interactions
Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

责任编辑:admin


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