Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT).

吉利德科学公司（纳斯达克股票代码：GILD）今天公布了关键的 3 期 MYR301 研究的最终结果，结果显示，接受首创的进入抑制剂布列韦肽（bulevirtide）治疗的慢性丁型肝炎病毒（HDV）成人患者中，有 36%（64 人中的 23 人）在治疗结束时达到 HDV RNA 无法检测后，停药近两年仍保持病毒学抑制，该药物剂量为 2 毫克或 10 毫克。

In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. In addition, sustained post-treatment undetectable HDV RNA was more frequent in participants with longer on-treatment HDV RNA undetectability at end of treatment: 90% (9/10) of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment.

在治疗结束后保持一年内检测不到病毒的参与者中，在第二年的随访中没有出现复发。此外，治疗结束时HDV RNA持续检测不到的频率在治疗期间较长时间HDV RNA检测不到的参与者中更高：治疗结束时HDV RNA检测不到时间≥96周的参与者中有90%（9/10）在停止治疗后仍然保持HDV检测不到。

These new data, presented at the European Association for the Study of the Liver (EASL) Congress 2025, show the potential value of bulevirtide monotherapy for some adults living with chronic HDV, even after treatment has ended..

这些新数据在 2025 年欧洲肝病研究协会 (EASL) 大会上公布，显示了布列韦肽单药疗法对部分慢性 HDV 患者在治疗结束后仍具有潜在价值。

“HDV is the most severe form of viral hepatitis with more rapid progression towards liver cancer and liver-related death. Previous data have demonstrated the potential of bulevirtide as a safe and effective treatment option and, as EASL and the European Medicines Agency guidelines recommend, continued treatment is encouraged as long as people are experiencing a clinical benefit,” said Professor Heiner Wedemeyer, Head and Chair of the Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology at Hannover Medical School.

“HDV是病毒性肝炎中最严重的形式，其向肝癌和肝相关死亡的进展更为迅速。以往的数据已经证明了bulevirtide作为一种安全有效的治疗选择的潜力，并且正如EASL和欧洲药品管理局指南所推荐的，只要患者有临床获益，就应鼓励继续治疗，”汉诺威医学院胃肠病学、肝病学、传染病和内分泌科主任兼主席Heiner Wedemeyer教授说道。

“With today’s results, we’re now seeing the potential of bulevirtide to maintain virologic suppression and normalize markers of liver inflammation for a subset of people living with HDV, demonstrating a durable response, even after treatment cessation.”.

“通过今天的结果，我们现在已经看到 bulevirtide 在一部分 HDV 患者中维持病毒学抑制和正常化肝脏炎症标志物的潜力，即使在治疗停止后也显示出持久的反应。”

The findings (LBO-004) build on data, presented at The Liver Meeting

研究结果（LBO-004）基于在肝脏会议上展示的数据，

2024, hosted by the American Association for the Study of Liver Diseases (AASLD), from MYR301 which demonstrated a subset of participants treated with bulevirtide monotherapy had undetectable HDV RNA 48 weeks after stopping treatment. Today’s presentation adds further insight by not only showing the durability of response post-treatment, but that sustained undetectability was more frequent in people with longer, on-treatment HDV RNA undetectability at the time of bulevirtide discontinuation.

2024年，由美国肝病研究协会（AASLD）主办，来自MYR301的研究显示，一部分接受布列韦肽单药治疗的参与者在停止治疗48周后HDV RNA仍检测不到。今天的报告进一步提供了深入见解，不仅展示了治疗后应答的持久性，还表明在布列韦肽停药时，治疗期间HDV RNA较长时间检测不到的患者中，持续不可检测的比例更高。

Furthermore, post-treatment hepatic serious adverse events (SAEs) were reported in 14% (20/142) of participants but were resolved in 85% (17/20) of these participants, most of whom restarted bulevirtide therapy..

此外，14%（20/142）的参与者报告了治疗后肝脏严重不良事件（SAEs），但其中85%（17/20）的参与者得到了解决，大多数重新开始了布列韦肽治疗。

“At Gilead, we are committed to advancing research and exploring the full potential of bulevirtide as a monotherapy, in combination, and at different doses, to help improve outcomes for people living with chronic HDV,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead.

“在吉利德，我们致力于推进研究，充分挖掘布列韦肽作为单一疗法、联合疗法以及不同剂量下的潜力，以帮助改善慢性丁型肝炎患者的生活质量，”吉利德公司肝炎、呼吸系统和新兴病毒临床研究副总裁阿努·奥辛乌西表示。

“Previous results from MYR301 demonstrated the potential benefits of long-term treatment with bulevirtide. With this new data, we now have valuable insight into the durability of the response even after treatment has ended.”.

“MYR301的先前结果已经证明了长期使用布列韦肽治疗的潜在益处。通过这项新数据，我们现在对治疗结束后反应的持久性有了宝贵的见解。”

HDV affects an estimated 4.5% of people living with chronic hepatitis B (HBV), with an estimated global prevalence of 12 million people. Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), the UK, Switzerland and Australia and is not approved in the U.S.

据估计，4.5%的慢性乙型肝炎（HBV）患者受到丁型肝炎病毒（HDV）的影响，全球约有1200万人感染。Bulevirtide 2 mg仍然是欧洲经济区（EEA）、英国、瑞士和澳大利亚唯一获批用于治疗成人慢性HDV及代偿性肝病的药物，但尚未在美国获批。

or elsewhere. Bulevirtide 10 mg is an investigational product and is not approved anywhere..

或在其他地方。Bulevirtide 10 mg 是一种研究性产品，尚未在任何地方获得批准。

Marketing Authorization

营销授权

In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex

2023年7月，欧洲委员会（EC）授予Hepcludex完全市场授权（MA）。

(bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide’s conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024.

布列韦肽2毫克用于治疗患有慢性HDV和代偿性肝病的成人。布列韦肽最初于2020年7月获得欧洲委员会（EC）的有条件上市许可（MA），以使HDV患者能够紧急获得治疗。布列韦肽在英国的有条件MA许可于2023年8月转为完整MA许可，并于2024年2月在瑞士获得了完整MA许可。

In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally..

在尚未批准布列韦肽的地区（包括美国），布列韦肽 2 毫克属于研究性药物。在这些地区，卫生部门尚未确定布列韦肽的安全性和有效性。布列韦肽 10 毫克属于研究性药物，在全球任何地方均未获批准。

About MYR301

关于MYR301

MYR301 is a Phase 3 clinical trial evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51). Primary efficacy and safety data was assessed at Week 48.

MYR301是一项三期临床试验，评估了布列韦肽在150名慢性HDV感染者中的长期疗效和安全性。患者被随机分配至每日一次2毫克布列韦肽组（n=49）、每日一次10毫克布列韦肽组（n=50）或未接受抗病毒治疗（延迟治疗，n=51）。主要疗效和安全性数据在第48周时进行了评估。

After Week 48, participants in the delayed treatment group of the study were switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks. The primary endpoint, combined response, is defined as an undetectable HDV RNA or ≥2log10 IU/ml decline from baseline and ALT normalization at Week 48.

在第48周后，研究中延迟治疗组的参与者转为每日一次服用10毫克布列韦肽，持续额外96周。研究中所有组的总治疗时长为144周。主要终点，即综合反应，定义为在第48周时HDV RNA检测不到或从基线下降≥2log10 IU/ml且ALT恢复正常。

Secondary endpoints at Week 48 include undetectable HDV RNA (key secondary endpoint), ALT normalization, and a change from baseline in liver stiffness measured by transient elastography..

48周时的次要终点包括检测不到的HDV RNA（关键次要终点）、ALT正常化以及通过瞬时弹性成像测量的肝硬度相对于基线的变化。

About Gilead Sciences in Liver Disease

关于吉利德科学在肝病领域

For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta (HDV), Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures.

几十年来，吉利德一直致力于改善全球肝病患者的生活。公司已帮助将丙型肝炎从一种慢性疾病转变为可治愈的疾病。对于乙型肝炎或丁型肝炎（HDV）患者，吉利德专注于推进药物研发，为今天的科研转化为明天的治愈方案带来了希望。

Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with primary biliary cholangitis. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease.

除了病毒性肝炎，吉利德还致力于为原发性胆汁性胆管炎患者提供先进的治疗方案。吉利德的承诺不止于此。通过突破性的科学和协作伙伴关系，该公司努力为所有肝病患者创造更健康的未来。

Gilead remains devoted to a future without liver disease..

吉利德仍然致力于实现一个没有肝病的未来。

About Gilead Sciences

关于吉利德科学公司

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation.

吉利德科学公司是一家生物制药公司，三十多年来一直致力于医学领域的突破，旨在为全人类创造一个更健康的世界。公司致力于推进创新药物的研发，以预防和治疗危及生命的疾病，包括艾滋病、病毒性肝炎、新冠肺炎、癌症和炎症等。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California..

吉利德在全球35多个国家开展业务，总部位于加利福尼亚州的福斯特城。