FDA批准抗丙型肝炎新药索非布韦(sofosbuvir)上市

FDA approved hepatitis C virus drug Sovaldi(sofosbuvir)

全球丙型肝炎病毒(HCV)的感染率高,且缺少有效的治疗药物。2013年12月6日,美国食品药物监督管理局(FDA)批准新分子实体药物索非布韦(sofosbuvir)片剂上市,商品名Sovaldi,用于慢性丙型肝炎的治疗。索非布韦是一种HCV聚合酶抑制剂,作用于病毒RNA复制的核苷酸类似物NS5B聚合酶位点,能中止病毒复制,是以NS5B聚合酶为靶点的唯一上市品种。本品与聚乙二醇干扰素/利巴韦林或单独与利巴韦林联用,与标准治疗方案相比治愈率更高且缩短给药时间,有广阔的应用前景。

In worldwide, the infection of hepatitis C virus（HCV） is high, but effective treatments were lacking. In December 6, 2013, US Food and Drug Administration（FDA） approved a new drug molecular entity for the tablet of sofosbuvir, with the brand name of Sovaldi. It could treat chronic hepatitis C. As an HCV polymerase inhibitor, sofosbuvir binds to the NS5B active site, causing the termination of RNA chain replication in HCV. For targeting of NS5B polymerase, it is the only approved drug in the world. Sofosbuvir combined with pegylated interferon（Peg-IFN）-ribavirin（RBV） or with only RBV has better effects than standard treatment regimen on improving response rates and reducing treatment time, with broad application prospects.