全球丙型肝炎病毒（HCV）的感染率高，且缺少有效的治療藥物。2013年12月6日，美國食品藥物監(jiān)督管理局（FDA）批準新分子實體藥物索非布韋（sofosbuvir）片劑上市，商品名Sovaldi，用于慢性丙型肝炎的治療。索非布韋是一種HCV聚合酶抑制劑，作用于病毒RNA復(fù)制的核苷酸類似物NS5B聚合酶位點，能中止病毒復(fù)制，是以NS5B聚合酶為靶點的唯一上市品種。本品與聚乙二醇干擾素/利巴韋林或單獨與利巴韋林聯(lián)用，與標準治療方案相比治愈率更高且縮短給藥時間，有廣闊的應(yīng)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.