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FDA批准Zepatier用于治疗基因型1型和4型的慢性病毒性丙肝

2016-01-31 QQduhp 译 MedSci原创

美国食品和药物管理局已批准Zepatier(elbasvir/grazoprevir)联合/不联合利巴韦林用于治疗慢性丙型1和4型基因型病毒(HCV)感染的成人患者。丙型肝炎是一种由病毒引起的肝脏炎症进而导致肝功能下降或肝功能衰竭的病毒性疾病。大多数人感染丙肝病毒后没有任何症状,需要几年时间的进展肝损伤才会变得明显。有些人患有慢性丙肝病毒感染数年后发展为肝硬化,从而导致一些并发症如出血、黄疸、腹腔

美国食品和药物管理局已批准Zepatier(elbasvir/grazoprevir)联合/不联合利巴韦林用于治疗基因型为1和4型的慢性丙肝病毒(HCV)感染的成人患者。

丙型肝炎是一种由病毒引起的肝脏炎症,会导致肝功能下降或肝功能衰竭的病毒性疾病。大多数人感染丙肝病毒后没有任何症状,需要几年时间的进展肝损伤才会变得明显。有些人患有慢性丙肝病毒感染数年后发展为肝硬化,从而导致一些并发症如出血、黄疸、腹腔积液、感染或肝癌等的出现。根据CDC的数据显示,约有300万美国人感染丙肝病毒,1、4型基因型是最常见的类型。 

Edward Cox博士指出,这种口服药物治疗对1和4型基因型丙肝病毒肝炎患者有效,且不需要使用干扰素。
 
研究人员对1373名参与者进行了临床试验,其目的是评估慢性HCV基因型1或4型感染者(伴发或未伴发肝硬化)使用Zepatier联合或不联合利巴韦林的安全性和有效性。参与者每天服用Zepatier和(不和)利巴韦林,持续12或16周,然后抽取参与者的血液标本,以检测他们血液中的丙型肝炎病毒数量和持续病毒学应答(SVR),以评估参与者的感染是否得以治愈。 

慢性HCV基因型1型感染者总体SVR范围为94-97%,4型基因型感染者SVR为97-100%。为了实现病人的SVR最大化,研究人员建议根据病人的自身特点和病毒数量合理规划治疗时长,并根据需要加入利巴韦林。

Zepatier若不结合利巴韦林使用,最常见的副作用是疲劳、头痛和恶心。若联合利巴韦林使用,最常见的副作用是贫血和头痛。
 
一般在治疗后8周,约1%的临床试验者服用Zepatier后会出现肝酶升高,高于正常值5倍。且医务人员需在治疗开始或定期进行抽血以复查相关指标。中度或重度肝损伤的患者不应服用Zepatier。
 
研究人员指出,Zepatier对治疗慢性HCV基因型1型和4型合并肾衰竭需血液透析的感染患者具有较好的治疗效果。但他们也表示还需进行更多的临床药物试验。

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    2016-03-19 bugit
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    2016-12-25 gous
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    2016-08-05 howi
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    2016-02-02 qjddjq
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    2016-02-02 gwc384

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