美国FDA批准Hepcludex：首款治疗慢性丁型肝炎病毒感染的药物
美国食品药品管理局（FDA）宣布批准吉利德科学公司（Gilead Sciences）的Hepcludex上市，用于治疗慢性丁型肝炎病毒（HDV）感染。这是首款获批用于该疾病的治疗药物。
丁型肝炎病毒需要与乙型肝炎病毒共同感染才能复制，被认为是病毒性肝炎中较为严重的一类。支持此次批准的MYR301试验数据显示，在第48周时，Hepcludex组达到复合应答的患者比例为48%，而延迟治疗组为2%；第48周丁型肝炎病毒RNA检测不到的比例为20%比0%，并在第96周与第144周分别升至36%与50%。
Hepcludex的推荐用法为每日一次、每次8.5毫克。该药带有黑框警告：停药可能导致丁型与乙型肝炎严重急性加重。常见不良反应包括超敏反应（含过敏性休克）、注射部位反应、头痛、腹痛、疲劳与瘙痒。
FDA此前已授予该药突破性疗法与孤儿药资格认定，此次经优先审评程序以加速批准方式获批。
（消息来源：美国食品药品管理局批准公告）
FDA Approves Hepcludex: First Treatment for Chronic Hepatitis Delta Virus Infection
The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences' Hepcludex for the treatment of chronic hepatitis delta virus (HDV) infection, the first treatment approved for the disease.
HDV can replicate only in people also infected with hepatitis B virus and is considered among the most severe forms of viral hepatitis. In the MYR301 trial supporting the approval, the combined response rate at week 48 was 48% with Hepcludex versus 2% with delayed treatment. Undetectable HDV RNA was achieved by 20% of treated patients at week 48 versus 0%, rising to 36% at week 96 and 50% at week 144.
Hepcludex is given once daily at 8.5 mg. The drug carries a boxed warning that discontinuation may cause severe acute exacerbations of HDV and hepatitis B. Side effects include hypersensitivity reactions including anaphylaxis, injection-site reactions, headache, abdominal pain, fatigue and pruritus.
The FDA had previously granted the drug Breakthrough Therapy and Orphan Drug designations, and the approval was granted under Priority Review through the Accelerated Approval pathway.
(Source: U.S. Food and Drug Administration approval announcement)
来源：GSM·美国（原文链接）
图片来源：肝脏三维医学示意图。（Wikimedia Commons，CC BY-SA 4.0，Scientific Animations作）A 3D medical illustration of the human liver. (Wikimedia Commons, CC BY-SA 4.0, by Scientific Animations)
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