FDA批准首款慢性乙型肝炎治疗药物
正文 · 中文译文
FDA新闻稿 FDA批准首个慢性乙型肝炎治疗药物 新疗法或可使部分患者在停用全部乙型肝炎治疗后仍维持病毒控制 更多新闻公告 立即发布： 2026年10月20日 美国食品药品监督管理局今日批准Hibsago（bepirovirsen）注射液与现有抗病毒疗法联合使用，用于治疗某些无肝硬化的成人慢性乙型肝炎病毒（HBV）感染。Hibsago是FDA批准的首个用于治疗慢性乙型肝炎的反义寡核苷酸药物。Hibsago获批用于某些无肝硬化的成人患者，这些患者已接受HBV抗病毒治疗至少六个月，血液中HBV水平受到抑制，且乙型肝炎表面抗原（HBsAg）水平为3,000 IU/mL或以下（由FDA授权的检测确定）。 “对于许多慢性乙型肝炎患者而言，治疗可能意味着服用抗病毒药物数年以保持病毒受抑制，”药物评价与研究中心传染病办公室主任Wendy Carter（DO）表示。“Hibsago提供了一种新的治疗方法，使部分患者在结束全部慢性HBV治疗后仍有可能维持对病毒的控制。此次批准对于患有这种严重疾病的患者而言是一项重要进展。” 慢性乙型肝炎是由HBV引起的长期肝脏感染。随着时间的推移，该感染可导致严重的肝脏疾病，包括肝硬化，并增加罹患肝癌的风险。Hibsago通过靶向病毒用于复制自身及生成病毒蛋白的遗传指令发挥作用，有助于减少体内的病毒量和乙型肝炎表面抗原。 美国食品药品监督管理局还批准了罗氏Elecsys HBsAg II定量II RxDx检测作为伴随诊断设备，以帮助根据FDA批准的药品说明书选择慢性HBV感染患者接受抗病毒治疗，并在整个治疗过程中协助监测患者。 研究人员在两项临床试验中将Hibsago与安慰剂（一种非活性治疗）进行了比较。Hibsago通过皮下注射给药，最长持续24周。患者在使用现有乙肝药物的同时接受该药治疗，并在最后一次注射Hibsago后至少继续使用现有药物24周。部分患者若满足特定的健康和实验室检查要求，之后可能能够停用现有药物。 在这两项试验中，接受Hibsago治疗的患者中有24%达到了停用现有药物的要求，而接受安慰剂的患者中无一例达到。在停止所有乙肝治疗24周后，接受Hibsago治疗的患者中有19%的病毒仍得到控制，且其血液中检测不到提示乙肝感染的蛋白质（HBsAg）。 Hibsago 具有关于严重肝脏反应以及低血小板计数的黑框警告，低血小板计数可能增加潜在危及生命的出血风险。Hibsago 同时还有关于肾功能恶化、严重炎症性不良事件（如血管炎）的警告，以及如果注射操作不当可能导致的严重风险。患者在治疗前和治疗期间需要定期进行血液检查并随访其医疗保健提供者，以监测这些风险。最常见的副作用（不包括实验室异常）为注射部位反应、发热、疲乏和头痛。 美国食品药品监督管理局（FDA）授予 Hibsago 快速通道和突破性疗法认定以及优先审评资格。该批准授予葛兰素史克公司（GSK plc）。 媒体联系方式： FDA 意见征询 202-690-6343 消费者联系方式： 888-INFO-FDA 美国食品药品监督管理局（FDA）是美国卫生与公众服务部下属机构，通过确保人用和兽用药物、疫苗及其他人类生物制品和医疗器械的安全性、有效性和可靠性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、放射性电子产品的安全与保障，并负责监管烟草制品。 ### 当前内容更新日期： 2026年10月20日 受监管产品： 生物制品 药物 关注 FDA 在 X 平台关注 @US_FDA 在 Facebook 关注 FDA 在 X 平台关注 @FDAMedia
正文 · 英文原文
FDA News Release FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment New treatment may allow some patients to maintain viral control after stopping all hepatitis B therapy More Press Announcements For Immediate Release: October 20, 2026 The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B. Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test. “For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.” Chronic hepatitis B is a long-term liver infection caused by HBV. Over time, the infection can lead to serious liver disease, including cirrhosis, and increase the risk of liver cancer. Hibsago works by targeting the genetic instructions the virus uses to make copies of itself and viral proteins, helping reduce the amount of virus and hepatitis B surface antigen in the body. The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to aid in the selection of patients with chronic HBV infection for treatment with antiviral therapy in accordance with the FDA approved drug labeling and to assist in monitoring patients throughout the course of treatment. Researchers studied Hibsago in two clinical trials that compared it with a placebo, an inactive treatment. Hibsago is injected under the skin for up to 24 weeks. Patients take it alongside their existing hepatitis B medicine and continue that medicine for at least 24 weeks after their last Hibsago injection. Some patients may then be able to stop their existing medicine if they meet certain health and lab test requirements. Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo. Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control, and a protein that signals hepatitis B infection (HBsAg) could not be detected in their blood. Hibsago has a boxed warning for serious liver reactions as well as low platelet counts, which can increase the risk of potentially life-threatening bleeding. Hibsago also has warnings for worsening kidney function, serious inflammatory adverse reactions like vasculitis, and serious risks if the injection is not administered properly. Patients need regular blood tests and follow up with their healthcare provider before and during treatment to monitor these risks. The most common side effects, excluding laboratory abnormalities, are injection site reactions, fever, fatigue and headache. The FDA granted Hibsago Fast Track and Breakthrough Therapy designations as well as Priority Review. The approval was granted to GSK plc. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. ### Content current as of: 10/20/2026 Regulated Product(s) Biologics Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X