更新于：2024-05-01

Hepatitis D

丁型肝炎

更新于：2024-05-01

基本信息

别名

Amazon Black Fever、Black Fever, Amazon、Delta Hepatitis

+ [46]

简介

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

关联

项与丁型肝炎相关的药物

Bulevirtide Acetate

靶点

NTCP

作用机制

NTCP结合剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2020-07-31

Ropeginterferon alfa-2b-NJFT

靶点

IFNAR

作用机制

IFNAR激动剂 [+2]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2019-02-15

Adjuvanted Hepatitis B vaccine (Recombinant)(Dynavax Technologies Corp.)

靶点

HBsAg x TLR9

作用机制

HBsAg抑制剂 [+1]

在研机构

Dynavax Technologies Corp. [+1]

原研机构

Dynavax Technologies Corp.

在研适应症

丁型肝炎 [+2]

非在研适应症

慢性肾病 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2017-11-09

105

项与丁型肝炎相关的临床试验

NCT05953545 / Not yet recruiting临床2期IIT

Open Label Phase 2 Clinical Study of Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis

Background:
Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications are approved to treat chronic hepatitis D.
Objective:
To test a combination of 3 drugs in people with chronic hepatitis D.
Eligibility:
People 18 years or older with chronic hepatitis D.
Design:
Participants will be in the study about 2 years. They will have 3 inpatient stays of 3 to 5 days.
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function and an ultrasound: a wand that uses sound waves to create images of the liver will be rubbed over the skin on their torso.
Participants will stay in the clinic for a 3-day baseline visit. They will have imaging scans, an eye exam, and a visit with a reproductive specialist. They will have a liver biopsy: about 1 inch of liver tissue will be removed, either with a tube inserted through a vein in the neck, or with a needle inserted through the participant s side.
Participants will take the study drugs for 48 weeks. Two of them are tablets taken twice a day at home; 1 is a shot administered once a week. Participants will begin taking the drugs during a 5-day stay in the clinic. Then they will have 15 outpatient visits while taking the drugs and 7 more after they finish.
The last 3-day clinic stay will be 6 months after participants finish taking the drugs. The liver biopsy, imaging scans, and other tests will be repeated.

开始日期2024-05-01

申办/合作机构

National Institute of Diabetes & Digestive & Kidney Diseases

NCT06248580 / RecruitingN/A

Find HDV and Determine Its Status in Turkey "SITU(HD)VATION"

The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

开始日期2024-03-11

申办/合作机构

Gilead Sciences, Inc.

NCT06264583 / Not yet recruitingN/A

Euro-HDV:Epidemiology and Clinical Course in Patients With HIV and Hepatitis B/D -Coinfection

The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.
1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.
1. Evaluation of former screening of HDV by assessing existing data at study sites.
2. Determination of the HDV prevalence in European PLWH and HBV coinfection.
2. Setting up a database of all PLWH with HBV/HDV coinfection
1. Analysis of transmission risk factors for HDV coinfection
2. Asses the rate of HDV positive patients with ongoing HDV replication.
3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results.

开始日期2024-03-01

申办/合作机构

Universitätsklinikum Bonn

[+10]

100 项与丁型肝炎相关的临床结果

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100 项与丁型肝炎相关的转化医学

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0 项与丁型肝炎相关的专利（医药）

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2,516

项与丁型肝炎相关的文献（医药）

2024-02-08·Journal of hepatology

Blocking viral entry with bulevirtide reduces the number of HDV-infected hepatocytes in human liver biopsies.

Article

作者: Lena Allweiss ; Annika Volmari ; Vithika Suri ; Jeffrey J Wallin ; John F Flaherty ; Dmitry Manuilov ; Bryan Downie ; Marc Lütgehetmann ; Jan-Hendrik Bockmann ; Stephan Urban ; Heiner Wedemeyer ; Maura Dandri

BACKGROUND & AIMS:

Bulevirtide (BLV) is a first-in-class entry inhibitor and the only approved treatment for patients chronically infected with HDV in Europe. We aimed to investigate the efficacy of BLV treatment in paired liver biopsies obtained at baseline and after 24 or 48 weeks of treatment.

METHODS:

We performed a combined analysis of 126 paired liver biopsies derived from 3 clinical trials. In the phase 2 clinical trial MYR202, patients with chronic hepatitis D were randomised to receive 24 weeks of BLV at 2mg, 5mg or 10mg/day. Patients in MYR203 (phase 2) and MYR301 (phase 3) received 48 weeks of 2mg or 10mg/day BLV. Tenofovir disoproxil fumarate monotherapy or delayed treatment served as comparator. Virological parameters and infection-related host genes were assessed by qPCR and immunohistochemistry.

RESULTS:

At week 24, median intrahepatic HDV RNA decline from baseline was 0.9Log10 with 2mg (n=7), 1.1Log10 with 5mg (n=5) and 1.4Log10 with 10mg (n=7). At week 48, median reductions were 2.2Log10 with 2mg (n=27) and 2.7Log10 with 10mg (n=37), while HDV RNA levels did not change in the comparator arms. Notably, a drastic decline in the number of hepatitis delta antigen positive hepatocytes and a concomitant decrease of transcriptional levels of inflammatory chemokines and interferon-stimulated genes was determined in all BLV-treatment arms. Despite the abundance of HBsAg-positive hepatocytes, replication and covalently closed circular DNA (cccDNA) levels of the helper virus HBV were low and remained unaffected by BLV treatment.

CONCLUSION:

Blocking viral entry diminishes signs of liver inflammation and promotes a strong reduction of HDV infection within the liver, thus suggesting that some patients may achieve HDV cure with long-term treatment.

IMPACT AND IMPLICATIONS:

Chronic infection with the hepatitis delta virus causes the most severe form of viral hepatitis affecting approximately 12 million people worldwide. The entry inhibitor bulevirtide (BLV) is the only recently approved anti-HDV drug, which has proven efficacious and safe in clinical trials and real-word data. Here, we investigated paired liver biopsies at baseline and after 24 or 48 weeks of treatment from three clinical trials to understand the effect of the drug on viral and host parameters in the liver, the site of viral replication. We found that BLV treatment strongly reduces the number of HDV-infected cells and signs of liver inflammation. This data implies that blocking viral entry ameliorates liver inflammation and that prolonged treatment regimens might lead to HDV cure in some patients. This concept will inform further developments of therapeutic strategies and combination treatments in CHD patients.

2024-02-05·Vaccines

The Impact of Clinical Factors and SARS-CoV-2 Variants on Antibody Production in Vaccinated German Healthcare Professionals Infected Either with the Delta or the Omicron Variant.

Article

作者: Catharina Gerhards ; Marlene Steingass ; Alexandra Heininger ; Bettina Lange ; Michael Hetjens ; Marlis Gerigk ; Michael Neumaier ; Osman Evliyaoglu ; Maximilian Kittel

BACKGROUND:

The aim of the rapid introduction of vaccines during the COVID-19 pandemic was a reduction in SARS-CoV-2 transmission and a less frequent occurrence of severe COVID-19 courses. Thus, we evaluated COVID-19 severity in vaccinated individuals to examine variant-specific symptom characteristics and their clinical impact on the serological immune response.

METHODS:

A total of 185 individuals previously vaccinated against and infected with the SARS-CoV-2 Delta (B.1.617.2) or Omicron (BA.4 and BA.5) variant, were enrolled for anti-SARS-CoV-2 anti-N- and anti-RBD/S1-Ig level detection. A structured survey regarding medical history was conducted.

RESULTS:

In 99.5 percent of cases, outpatient treatment was satisfactory. Specific symptoms associated with variants included ageusia and anosmia in patients with Delta infections and throat pain in Omicron infections. Among Delta-infected individuals with specific symptoms, significantly higher levels of anti-N antibodies were observed.

CONCLUSION:

Our study identified variant-specific differences in the amount of SARS-CoV-2 antibody production and COVID-19 symptoms. Despite this, vaccinated individuals with Omicron or Delta infections generally experienced mild disease courses. Additionally, asymptomatic individuals exhibit lower anti-SARS-CoV-2 antibody levels, indicating a clinical correlation between disease-specific antibodies and distinct symptoms, particularly in the case of the Delta variant. In follow-up studies, exploring post-COVID syndrome and focusing on cognitive symptoms in the acute phase of Omicron infections is crucial as it has the potential to longitudinally impact the lives of those affected.

2024-02-03·Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

Impact of anti-HDV reflex testing at HBs antigen positive discovery in a single center France: Support for primary HDV screening in France.

Article

作者: Assilina Parfut ; Simona Tripon ; Pierre Gantner ; Fréderic Chaffraix ; Elodie Laugel ; Marie-Josée Wendling ; Furkan Erol ; Carine Wiedemer ; Michel Doffoel ; Antonio Saviano ; Maude Royant ; François Habersetzer ; Samira Fafi-Kremer ; Aurélie Velay

BACKGROUND:

Hepatitis Delta virus (HDV) infection is a major cause of liver-related morbidity and mortality in patients infected with HBV, with a global HDV prevalence uncertain. In France, 2 to 5 % of HBs antigen (HBsAg) carriers present anti-HDV antibodies (anti-HDV). The EASL recommends testing for anti-HDV in all HBsAg-positive patients. Since January 2022, we have systematically carried out anti-HDV serology when a positive HBsAg is discovered (new HBsAg carriers).

OBJECTIVES:

We evaluated the benefit of anti-HDV reflex testing after one year of practice by comparing anti-HDV and HBsAg serology data over the last six years, among the new HBsAg carriers and all the HBsAg carriers.

STUDY DESIGN:

HBsAg and anti-HDV were screened using the Abbott Architect HBsAg quanti kit and the DIA.PRO HDVAb kit. Serological, demographic, virological, and clinical data were analyzed.

RESULTS:

Implementing anti-HDV reflex testing leads to more than a 2-fold increase in diagnoses of HDV infection among all HBsAg carriers. If the anti-HDV positive rate remains stable among the new HBsAg carriers, a significant increase in the anti-HDV positive rate from 6.8 % to 10.3 % was observed considering all HBsAg carriers. Interestingly, the discovery of anti-HDV carriage increased from 3.9 % to 6.5 % in 2022, allowing earlier identification of HBV-HDV-infected patients and a fast referral to hepatologists for adequate clinical management and, in some cases, the introduction of bulevirtide-based therapy.

CONCLUSIONS:

Our preliminary results at one year seem promising and evaluating the cost-effectiveness of reflex tests in real life with feedback would be helpful.

168

项与丁型肝炎相关的新闻（医药）

2024-04-05

·药融圈

顶级PI创立，战略切入布局ADC的Biotech

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：近期，华辉安健（北京）生物科技有限公司（“华辉安健”）宣布将在2024年4月5日至10日举行的美国癌症研究协会年会（AACR 2024）上展示其与普方生物共同开发的HH018-sesutecan的临床前研究结果。本品由华辉安健主导开发。药融云数据，www.pharnexcloud.com，专利数据HH018-sesutecan是一款 “first-in-class”候选抗体偶联药物（ADC），以华辉安健的抗-CD98单克隆抗体HH018为基础，并结合普方生物的sesutecan ADC平台开发的泛瘤种ADC，有望实现对多种肿瘤的高效且精准的抗肿瘤活性。HH-018单抗通过酸性pH依赖性地结合CD98，从而选择性地靶向酸性肿瘤微环境，不仅提升药物靶向肿瘤的特异性和安全性，而且具有良好的体内药代动力学特征。HH018-sesutecan能够通过内吞作用进入肿瘤细胞内，对肿瘤细胞具有强细胞毒性。在多种小鼠肿瘤模型中，如结直肠癌、头颈鳞癌、黑色素瘤、卵巢癌、淋巴瘤等，HH018-sesutecan表现出剂量依赖性的抗肿瘤活性。在食蟹猴体内进行的预毒理研究中，HH018-sesutecan显示了良好的药代动力学特征，在30mg/kg给药剂量下安全性良好。其中抗体相关专利为WO2022252167A1。Huahui Pipeline华辉安健是一家在2015年1月创立于中国北京，专注于病毒学、肝病学和相关肿瘤学领域创新药物研发的临床阶段生物科技公司。公司聚焦抗病毒（如乙肝、丁肝）和相关肿瘤学领域，具备从药物发现、临床前开发、转化科学研究、临床开发到生产与注册的“端到端（end-to-end）” 能力和完整体系。公司多款具有潜在“First-in-Class”或者“Best-in-Class”的在研药物处于临床开发阶段，包括有望实现慢性乙肝功能性治愈的单抗药物HH-003和HH-006、广谱抗新冠病毒融合蛋白HH-120、免疫肿瘤抗体HH-101、抗肿瘤靶向药HH-009等。公司由李文辉博士创立，联合创始人有隋建华博士；首席执行官/CEO陈彬博士、CSO叶斌博士（临床及科学转化）。1.HH-120是基于人ACE2的类IgM样重组融合蛋白，可以全谱高效中和所有通过ACE2受体介导的新冠病毒（包括XBB，BA2.86, 和JN.1等突变株）。HH-120药物不进入血液、无系统暴露风险。HH-120自2020年初新冠疫情开始研发。2023年12月，在《JOURNAL OF MEDICAL VIROLOGY》发表了题为“Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 prevents SARS‐CoV‐2 infection: Two investigator‐initiated postexposure prophylaxis trials”的研究成果。doi/10.1002/jmv.292752.2023年4月25日，华辉安健宣布其自主研发的创新药物HH-003注射液近日被国家药品监督管理局（NMPA）/药品审评中心（CDE）纳入突破性治疗品种（BTD），用于治疗慢性丁型肝炎病毒感染。本品为全球首个靶向乙肝病毒表面大包膜蛋白前S1（PreS1）区的乙肝病毒中和抗体。3.2023年2月9日，华辉安健与广州誉衡生物科技有限公司（以下简称“誉衡生物”）共同宣布建立临床研究合作伙伴关系。双方就华辉安健的抗TIGIT单克隆抗体HH-101注射液和誉衡生物的抗PD-1单克隆抗体赛帕利单抗注射液（商品名：誉妥®）展开联合治疗临床研究，旨在评估该联合用药在多种实体肿瘤患者中的有效性和安全性。新药并购案子又来了ADC新锐普方生物pipeline（包括rinatabart sesutecan (Rina-S; PRO1184)，一种靶向FRα的ADC；PRO1160，一种靶向CD70的ADC；PRO1107，一种靶向PTK7的ADC；以及PRO1286，一种靶向EGFR和cMET的双特异性ADC）。第一单！18亿美元，中国ADC企业被巨头并购。2024年4月3日，总部在丹麦哥本哈根的 Genmab A/S (纳斯达克代码:GMAB) 和普方生物（ProfoundBio, Inc.）宣布，两家公司已达成最终协议，Genmab将通过全现金交易收购普方生物。Genmab对普方生物的收购对价为18亿美元，在交易完成时将以现金支付。（目前198亿美元市值，关联阅读：从“垂死挣扎”到“起死回生”，Genmab如何吸引大厂争相合作）。参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；www.huahuihealth.com；https://pharma.bcpmdata.com/database/1/detail/48/_jomf44BfFW7AIEH5Gmb；https://profoundbio.com/；https://onlinelibrary.wiley.com/doi/10.1002/jmv.29275；https://www.huahuihealth.com/html/pressrelease/49.html；2022年会（AASLD 2022）公布HH-003首次在慢性乙肝病毒（HBV）感染者中的Ib期临床试验数据；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 8月 • NDC2024生物医药创新博览会关键词：抗体、多肽、核酸、核药，XDC、小分子、注册、临床、CMC（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

抗体药物偶联物AACR会议引进/卖出CSCO会议

2024-04-04

·PRNewswire

Huahui Health to Present Preclinical Data of HH018-sesutecan at the 2024 AACR Annual Meeting

BEIJING, April 4, 2024 /PRNewswire/ -- Huahui Health Ltd.("Huahui Health"), a clinical stage biotechnology company focused on discovering and developing virology, hepatology, and oncology therapies, announced that it will present the results of preclinical data of HH018-sesutecan, a tumor microenvironment targeting CD98-directed ADC, at the American Association for Cancer Research (AACR) Annual Meeting 2024. The AACR meeting will be held April 5–10, 2024, in San Diego, California. Topic: A tumor microenvironment-targeting CD98-directed ADC confers robust anti-tumor activity in multiple cancers with favorable pharmacokinetics and safety profiles in preclinical models Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: Wednesday Apr 10, 2024 9:00 AM - 12:30 PM Location: Poster Section 54 Poster Board Number: 1 Abstract Presentation Number: LB425 Presenter: Bin Chen, CEO of Huahui Health. Zhu Chen, CSO of ProfoundBio About Huahui Health Huahui Health is a clinical-stage biotechnology company founded in 2015 in Beijing, China. With a focus on virology, hepatology, and oncology, the company is dedicated to drug discovery, development, and antibody engineering. It has expanded its pipeline to include promising drug candidates in virology and oncology, aiming to launch multiple groundbreaking products and lead the way in antiviral and oncology research. Two leading programs have entered the pivotal clinical trial stage. One is HH-003, the first anti-preS1 HBV/HDV neutralizing antibody to enter a pivotal study for chronic HDV infection. The other is HH-120, an IgM-like ACE2-Fc recombinant fusion protein via nasal spray, currently undergoing a phase 3 trial for post-exposure prophylaxis of SARS-CoV-2. For more information, please visit . SOURCE Huahui Health Ltd.

临床3期AACR会议

2024-04-02

·BioSpace

Eiger Files for Bankruptcy, Plans to Shutter Operations After Difficult Year

Pictured: A U.S. federal bankruptcy courthouse building/iStock, GussWilder Eiger BioPharmaceuticals on Monday announced that it has voluntarily filed for bankruptcy and has kicked off the process of selling its assets and winding down the company’s operations. The California-based biotech has filed for Chapter 11 protection with the Bankruptcy Court for the Northern District of Texas, and has also submitted customary “first day” motions. If granted, the motion will provide Eiger some relief allowing it to transition into bankruptcy while it meets the company’s commitments to its stakeholders without “material disruptions” to its ordinary operations, according to the announcement. Eiger will sell all its assets during the bankruptcy case as it prepares for “an orderly wind down” of its operations. As part of the process, the biotech has inked a “stalking horse” agreement with rare disease player Sentynl Therapeutics which has agreed to purchase Zokinvy (lonafarnib), a farnesyltransferase inhibitor approved to treat the rare and progressive genetic disease Hutchinson-Gilford progeria syndrome. Sentynl will pay up to $26 million for Zokinvy, with the final price subject to other adjustments including per diem reductions. Zokinvy is an oral small molecule drug that blocks the farnesyltransferase protein. It is also approved for use in processing-deficient progeroid laminopathies with specific genetic mutations. The companies expect to close the sale by April 24, 2024. As part of its bankruptcy filing, other bidders can also submit competing offers for Eiger’s assets through a court-supervised process. Eiger’s bankruptcy filing on Monday caps off a difficult year for the biotech. In September 2023, it announced that it was discontinuing the Phase III LIMT-2 study of its candidate peginterferon lambda for chronic hepatitis delta. A quarterly review by a Data Safety Monitoring Board (DSMB) found concerning safety signals associated with peginterferon lambda. Four patients who received the investigational therapy developed hepatobiliary events, which led to liver compensation, leading the DSMB to recommend the study’s discontinuation. In September 2022, the FDA also rejected Eiger’s application for an Emergency Use Authorization for peginterferon lambda, which the biotech was proposing for the treatment of mild-to-moderate COVID-19. Following this rejection, Eiger in June 2023 laid off 25% of its workers in a sweeping reprioritization and savings program. The initiative also included a pivot to its GLP-1 receptor antagonist avexitide, which at the time was being developed for post-bariatric hypoglycemia and congenital hyperinsulinism. Eiger expected the cost-cutting measures to support its operations through the fourth quarter of 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床3期上市批准并购优先审批加速审批