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【置顶】美国食品及药品管理局(FDA)已批准治疗丙肝新药Epclusa

2016-08-02 00:00


美国食品及药品管理局(FDA)已批准治疗丙肝新药Epclusa

 

      The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
      美国食品及药品管理局(FDA)已批准Epclusa为治疗成人患者慢性丙型肝炎病毒(HCV)的新药,而且有无肝硬化(严重肝病)都适用。对于中重度肝硬化的患者(肝硬化失代偿),Epclusa可以同利巴韦林联合使用。Epclusa是片剂,含有一定量的索非布韦和velpatasvir,其中,索非布韦是2013年批准的药品。Epclusa是第一种可以治疗6种丙肝的新药。

      “This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
      FDA抗微生物产品评估及研究部主任Edward Cox说:这种新药为更广范围的患者提供了一个治疗和管理丙型肝炎的新选择。

      Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.
      丙型肝炎是一种病毒性疾病,能导致肝脏炎症,致使肝功能减退或肝衰竭。HCV有6种基因类型,在遗传学上存在着差异。了解病毒的基因类型,才能知道治疗方案和治疗时间的长短。在美国,约75%的丙肝患者为HCV1型;20 ——25%的患者为HCV2或3型;仅有一小部分患者感染的是HCV4、5、6型。根据疾病控制及预防中心的统计,75——85%的患者的HCV感染会转为慢性。慢性HCV感染多年的患者常带有并发症,如出血、黄疸病(眼睛和皮肤发黄)、腹部积液、感染、肝癌,直至死亡。

      The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.
      共有1558名患者,包括无肝硬化和患有代偿性肝硬化(轻度肝硬化)的患者,参与到III期临床试验中,评估Epclusa在12周内的安全性和有效性。其结果证实了95——99%的服用Epclusa的患者,在治疗结束后12周的血液测试中并未检测出病毒,这说明患者的感染已经被治愈。同样,也有267名失代偿肝硬化(中重度肝硬化)的患者参与到临床试验中,评估Epclusa的安全性和有效性。其中87名患者将Epclusa与利巴韦林连用,治疗12周。其中94%的患者在治疗结束后12周的血液测试中并未检测出病毒。

      The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.
      Epclusa最常见的副反应为头疼及疲乏。Epclusa与利巴韦林联用的治疗方案中,如果患者存在利巴韦林的禁忌症,那么对于此治疗方案也存在禁忌症。

      Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.
      Epclusa警告患者和医生,Epclusa会引起严重的心率变缓(症状性心动过缓)。有报道称,当胺碘酮与索非布韦和其他HCV直接抗病毒物质联用时,需要起搏器介入。胺碘酮和Epclusa的联合用药是不推荐的。Epclusa也警告不可与会降低血液中Epclusa量的某种特定药物联用,因为这会降低Epclusa的有效性。

      Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
      Epclusa是在FDA的优先评估程序中获批的。FDA的优先评估程序提供了对于治疗严重病症的药物的加速审批。如果通过,将在安全性和有效性上有大幅提高。

      Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.
      Epclusa由加利福尼亚州福斯特城的Gilded Sciences公司生产和销售。



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