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Financing prevention, testing and treatment of hepatitis in the context of Universal Health Coverage

POSTED ON: 23 Mar, 2020

Today, the global mortality from viral hepatitis exceeds that of HIV, TB or malaria, and is likely to exceed the toll from those three diseases combined by 2040. Viral hepatitis elimination meets all criteria for inclusion in the UHC framework. However, today, start-up funding is essential.

Read the new WHO Report on our joint side-event at the Global Fund’s replenishement’s conference here.

New Funding Opportunities for HBV Research (USA)

POSTED ON: 12 Mar, 2020

ICE-HBV welcomes the following new funding opportunities for HBV Research:

 

  • FY20 Peer Reviewed Medical Research Program (PRMRP), Department of Defense

This is an opportunity to submit proposals for hepatitis B research. You can download the application and eligibility criteria at https://cdmrp.army.mil/funding/prmrp. Pre-application letters of intent are due by April 16, 2020.

 

  • Research Towards Developing a Cure for HBV in HIV/HBV Co-Infection, NIAHD

This opportunity seeks to fill “scientific gaps needed to (a) inform HBV functional cure strategies by furthering our understanding of the interactions of HBV and HIV; and (b) advance the discovery and development of novel HBV interventions targeting HBV/HIV co-infection.” For more information, please visit: https://grants.nih.gov/grants/guide/pa-files/PAS-20-121.html

 

Strategic plan for trans-NIH research to cure hepatitis B

POSTED ON: 16 Dec, 2019

The US NIH just released a strategic plan to cure Hepatitis B. The plan includes a list of specific gaps in our knowledge that need to be filled to develop widely-effective, affordable, and deployable cures. The plan includes an intention to leverage existing NIH funds and programs to improve HBV research, as well as to increase funding for HBV studies in the future.

The NIH plan is fully in accord with efforts being promoted by ICE-HBV and the Hepatitis B Foundation.

Although the specifics of this plan apply to the US NIH, it is an excellent strategic guide for studies throughout the world that aim to accelerate HBV cure research.

Trans NIH Strategic Plan to Cure HBV, 2019

The Melbourne Declaration

POSTED ON: 28 Nov, 2019

Chronic hepatitis B, which is the leading cause of serious illnesses including liver cirrhosis and liver cancer, is a significant public health problem in the Asia Pacific region, affecting over 120 million people. It is estimated that fewer than 10% have been diagnosed, and less than 1% are receiving antiviral treatment. The World Health Organization has called for the elimination of hepatitis B as a public health threat by the year 2030. This can only be achieved through a massive increase in global prevention, public education and treatment and cure efforts that are undertaken in partnership with all concerned stakeholders, including those living with hepatitis B, with clear and agreed strategies to follow.

We support the recent strategic Roadmaps for HBV Cure from the Hepatitis B Foundation, International Collaboration to Eliminate HBV (ICE-HBV), and the World Hepatitis Alliance’s “Find the Missing Millions” campaign. We endorse the World Health Organization’s Global Health Sector Strategy on Viral Hepatitis 2016-2021, including the specific 2030 elimination goals that were agreed upon by all members of the World Health Assembly. To achieve these goals, we call for a substantial increase in government and industry funding dedicated for increased testing and molecular diagnostics, treatment and curative HBV research, and to facilitate equitable, affordable and universal access to an HBV cure within the next ten years.

 

 

The Melbourne Declaration was signed on October 5th 2019, by leaders of ICE-HBV, The Peter Doherty Institute for Infection and Immunity, the WHO Collaborating Centre for Viral Hepatitis, the Burnet Institute, the Hepatitis B Foundation, ANRS, Sidney Vo ( ommunity member) and was endorsed by the International Hepatitis B Meeting.

Scientific Advocacy at work! Australia to allow Sydney Vo to apply for new visa

POSTED ON: 26 Nov, 2019
We are pleased to announce that the deportation of Ms. Sidney Vo from Australia just because she is chronically infected with HBV has been stopped by a last minute intervention of an Australian minister. Ms. Vo gave a powerful presentation at the Public Forum that was part of the HBV Meeting in Melbourne. In it, she described in very personal terms the impact that the stigma from being diagnosed with HBV can have. Ms. Vo’s appeal of her deportation order was supported by a world-wide publicity campaign, which included strong support from ICE-HBV, the Hepatitis B Foundation, and the HBV meeting organizers.
Ms. Vo’s situation is an example of the stigma and discrimination that a great many people living with HBV face on a daily basis. Hopefully the publicity this case generated will call attention to the stigma of living with HBV and prompt changes that help others who face similar issues.
An article describing Ms. Vo’s struggle to remain with her son in Australia can be found here.

Universal Health Coverage & HIV – The Potential Impact of Collaborative Innovations with Viral Hepatitis Elimination at the Global Fund Replenishment Conference – Oct 8, 2019 – 1PM

POSTED ON: 24 Sep, 2019

ICE-HBV & partners are organizing a side-event at the Global Fund Replenishment Conference on October 8 from 1pm to 2:30pm. The session aims to underscore the potential public health impact of expanding viral hepatitis elimination programming, including through strategic integration with existing efforts to improve HIV care and prevention outcomes. To register, please contact info@ice-hbv.org.

As highlighted in WHO’s Progress report on HIV, viral hepatitis and sexually transmitted infections 2019, viral hepatitis caused 1.4 million deaths in 2016, a number comparable to deaths caused by tuberculosis and higher than those caused by HIV. However, the number of deaths due to viral hepatitis is increasing over time, while, thanks to the global effort to tackle these epidemics, mortality caused by tuberculosis and HIV is declining. Most viral hepatitis deaths are due to chronic liver disease. Globally, in 2015, an estimated 257 million people were living with chronic HBV infection, and 71 million people with chronic HCV infection. Among the 36.7 million persons living with HIV in 2015, an estimated 2.7 million had chronic HBV infection and 2.3 million had been infected with HCV. Liver diseases are a major cause of morbidity and mortality among those living with HIV and coinfected with viral hepatitis as well as some key populations infected with viral hepatitis and at high risk of HIV infection, including people who inject drugs and prisoners.

The WHO 2019 report highlights the critical connections between efforts to achieve the global targets of elimination of viral hepatitis and reductions in HIV incidence and mortality. Service coverage of HBV and HCV testing and treatment needs to be rapidly scaled up. Hepatitis services need to be delivered through a public health approach to benefit all, including through strategic integration with HIV programming where it makes sense. Sustainable financing is required to enable universal health coverage. Innovations are also essential; new diagnostics, treatments, cure and vaccines are being developed. They should be tested and delivered urgently to transform the hepatitis response and attain the elimination targets.

Session Objectives

– To highlight innovations in the viral hepatitis response that can have a wide public health impact and show how viral hepatitis elimination can contribute to Universal Health Coverage and to improving clinical outcomes for people living with HIV.
– To advocate for increased investments in viral hepatitis, including to achieve micro-elimination among people living with HIV and among key populations at risk of HIV, and beyond.
– To underline the feasibility of viral hepatitis elimination by looking at cost estimates, procurement systems and innovative financing. Due the existence of now affordable diagnostics and curative treatments for HCV, an effective and inexpensive HBV vaccine and the prospects for further innovations towards an HBV cure, enhanced investments made today can have a major impact on global health, within a short period of time.

Session Outline & Presentations

Co-Chairs – Pr François Dabis, ANRS + Charles Gore, EndHep 2030 and Medicines Patent Pool

Speaker – Dr Benjamin Cowie, WHO Collaborating Centre for Viral Hepatitis at the Doherty Institute
The State of the Viral Hepatitis Epidemic – Success and Challenges

Speaker – Dr Yvan Hutin, WHO, Geneva – The Price Tag + Universal Health Coverage: integrated services delivery for HIV & hepatitis

Speaker – Dr. Christian Ramers, Senior Clinical Advisor on Viral Hepatitis, Clinton Health Access Initiative
Leveraging rapidly falling commodity costs to improve clinical outcomes among people living with HIV and key populations through elimination of viral hepatitis.

Speaker – Jessica Hicks, Head of Programmes, World Hepatitis Alliance
Involving the affected community and civil society in innovative financing strategies

Speaker – Pr Massimo Levrero–Board member, International Coalition to Eliminate HBV
Collaborative Biomedical Innovations for Viral Hepatitis Elimination

Flyer

治愈乙型肝炎的科学战略

POSTED ON: 27 Jun, 2019

全球治愈乙肝Hepatitis B的科学战略

    2019年4月,国际消除HBV联盟(ICE-HBV)全球科学战略在《柳叶刀-胃肠病学和肝脏病学》(Lancet Gastroenterology and Hepatology)期刊上发表,为乙肝治愈研究和全球乙肝治愈准备奠定了基础。

    乙肝是一种与结核病、艾滋病以及疟疾相同规模的全球公共卫生威胁。全球有超过2.57亿人长期感染乙肝病毒,2017年有近90万人死于该病。

ICE-HBV是由全球研究人员、患者代表和卫生组织所组成,其制定的全球治愈乙肝的科学战略(简称ICE-HBV战略),推动了全球乙肝病毒治愈工作。

在《柳叶刀-胃肠病学和肝脏病学》期刊发表的同时,于奥地利维也纳召开的欧洲肝脏研究协会(EASL)国际肝病大会(International Liver Congress)开幕当天也发布了这一战略并进行了网络直播。

乙肝是一种损害肝脏的病毒性传染病,可引起急性和慢性疾病。乙肝病毒通过与被感染者的血液或其他体液接触传播。今天,慢性乙肝(CHB)病毒感染导致的死亡人数已超出疟疾致死人数。

慢性乙肝还导致约40%的肝细胞癌,肝细胞癌则是全球癌症相关死亡的第二大原因。

“每年约有90万人死于乙肝相关疾病,这简直令人无法接受,” ICE-HBV主席以及多尔蒂研究所(Doherty Institute)皇家墨尔本医院高级医学科学家彼特·热维尔(Peter Revill)教授称。

“令人费解的是,虽然慢性乙肝造成了巨大的人员和经济损失,但乙肝研究仍资金不足,无异于被忽视的热带病。乙肝治愈研究可产生重大意义,防止所有乙肝病毒(HBV)感染者出现不良反应,使他们能够接受免费治疗,过上充实的生活,并减少与这种慢性感染有关的污名。”

 

如果有乙肝疫苗和治疗药物,为什么还需要研究其治愈方法?

虽然存在安全、有效、能预防HBV感染的疫苗且其全球供应,对于消除HBV这一公共卫生威胁至关重要,但那些已经长期感染的患者还需要终生治疗。而目前,在数百万需要终生治疗的人当中,只有大约8%的人能够获得终生治疗,部分原因是疾病监测的复杂性。ICE-HBV战略强烈呼吁进行适当的治愈研究和准备,来补充世界卫生组织(World Health Organization)的全球消除HBV战略、HBV疫苗和耐受性良好但难以获得的疗法。

 

目前的治疗方案有助于控制HBV,但无法治愈HBV,因为它无法将病毒从被感染的细胞中彻底清除。cccDNA(共价闭合环状DNA)是一种特殊的DNA结构,产生于HBV繁殖期间,并有可能永久存在于细胞核内。感染HBV后,cccDNA可在患者接受临床治疗后继续存在于肝细胞内,甚至可以重新激活。

即使进行持续治疗,被感染者患上肝癌的风险仍然较高,特别是那些因慢性乙肝而患有潜在肝硬化的人。这引发了药物治疗依赖性的问题,并需要大量投资进行持续监测,从而为实现乙肝消除的目标增加了挑战。

双管齐下

为了实现HBV治愈的目标,ICE-HBV战略提出并详细阐述了两种主要方法:一种是在不杀死被感染细胞的情况下治愈HBV;另一种是通过诱导免疫控制,安全地清除被感染细胞。ICE-HBV战略认为,其中任何一种方法都需要得到协调良好的临床研究的支持,才能推动HBV治愈目标的实现。

ICE-HBV战略还引用了新的证据,即乙肝“出现症状的时间”比先前认识到的更早,并且HBV DNA的整合与肝癌有关。因此,在比目前建议的治疗时间更早的阶段进行治疗或许是明智之举。

新的合作是关键

“治愈乙肝不是一个白日梦,也不应该被这么认为,”乙肝基金会(Hepatitis B Foundation)董事会成员兼世界肝炎联盟(the World Hepatitis Alliance)新当选主席Dr Su Wang称。

“我们当中的2.57亿个乙肝患者迫切希望实现治愈乙肝的目标,以结束不必要的痛苦和死亡。我们赞同ICE-HBV战略,认为它是努力扩大必要的研究和合作以实现HBV治愈目标的标志。”

“我们相信,如果能够给予乙肝研究与丙肝治疗研发同等的精力和投资,将可以大大推动HBV治愈目标的实现。ICE-HBV战略的重要性在于它详细阐述了如何采用病毒学和免疫学的方法多管齐下对抗和根除致命的HBV。”

“不仅如此,ICE-HBV还具有里程碑意义,因为它不仅包括知名科学家和临床医生,还重视HBV患者群体的贡献。HBV治愈关系着患者的切身利益,他们理应成为我们治愈HBV之路上的合作伙伴。”

普及全民医保

最近的科学进展以及发现丙肝病毒治愈方法带来的强劲研究势头为寻找HBV治愈方法带来了一线希望。

ICE-HBV 正呼吁增加HBV治愈研究和准备方面的投资,以挽救全球2.57亿慢性乙肝(CHB)患者的生命,他们当中大多数人并未意识到自己感染了这一病毒。

虽然ICE-HBV支持世界卫生组织(World Health Organisation)全球卫生部门病毒性肝炎战略以及世界肝炎联盟的“寻找失踪的百万人群”(Find the Missing Millions)运动,但它还敦促我们普及全民医保以应对HBV。

 

“我们强烈认为,公共卫生及研究机构需要突破现有目标,通力合作,为HBV患者找到治愈方法并确保他们能够接受治愈性治疗。” ICE-HBV委员会成员、北京生命科学研究所研究员李文辉博士称。

 

建议

ICE-HBV战略提出了一系列为应对HBV需要展开的重点研究领域,包括:

消除HBV:

  • 制定标准化方法来定量检测cccDNA,并研究cccDNA动态平衡机制及其生物合成、结构、转录调控和降解的影响因素;
  • 确定HBV感染的机制:表征从病毒进入细胞到cccDNA合成再到稳定的所有步骤;
  • 改进研究cccDNA调控和病毒-宿主相互作用的方法,通过应用最先进的“组学”技术(如:基因组学、转录组学、蛋白质组学、代谢组学、激酶组学),在全基因组水平上增进对病毒-宿主相互作用的了解,揭示治疗方法的新靶点,消除cccDNA;
  • 开发和验证新的血清标志物(如:乙型肝炎病毒核心相关抗原(HBcrAgs)、HBV-RNA),作为肝脏内cccDNA活性的可靠生物学标志物。一旦发现并确认出标志物,确保它们得到标准化;
  • 开发用于降解HBV cccDNA的治疗方法;
  • 开发预防cccDNA转录和HBV DNA整合的治疗方法。继续开发阻止病毒复制周期中其他关键步骤的方法,这些方法可以纳入HBV治愈的联合策略中;
  • 开发高效便捷的体外功能性cccDNA系统;
  • 开发简便的体内模型,特别是易感染HBV的且具有免疫力的非人灵长类动物和小鼠模型。

 

HBV免疫调节

  • 利用现有的免疫干预手段进行临床研究;
  • 确定新生儿、儿童、青少年和成人的不同免疫分子在清除病毒、持续抗病毒、免疫应答和治疗反应中所扮演的不同角色;
  • 确定T细胞衰竭的机制以及T细胞恢复在何种程度上可逆、持久并且为控制病毒所需;
  • 确定B细胞在疾病自然史中所扮演的角色,以及如何能有效监测B细胞,用于研究和临床试验;
  • 研究肝脏微环境对于先天性和适应性细胞的组成和功能的影响,以及确定血液中最能反映肝脏内免疫应答的生物学标志物;
  • 确定每类患者中被感染的肝细胞数量以及清除它们所需的、在发生肝脏失代偿前仍可耐受的免疫介导性溶血的程度。

 

执行

  • 增加政府、私人资助机构以及慈善捐助者对个人以及合作性治愈研究项目的投资。应考虑建立国际研究联盟,如由美国国立卫生研究院(NIH)管理的关注艾滋病治疗研究的马丁德莱尼合作实验室(Martin Delaney

 

 

Collaboratory)。各国的HBV计划都应将HBV治愈研究投资战略放在首位。

  • 世界卫生组织消除乙肝战略(WHO Hepatitis Elimination Strategy)应得到充足的资金支持,应特别注重普及新生儿出生时接种首针疫苗,显著增加HBV研究资金,改善即时诊断,促进疾病治疗与治愈;
  • 专注于发现干预策略,永久减少产毒性感染的细胞数量,或永久抑制这些细胞中的cccDNA, 并诱导HBV特异性T细胞激活与中和抗体的产生,防止病毒扩散到其他细胞,模拟急性乙肝病毒感染后的自发性病毒清除;
  • 建立标准化的HBV试剂库和实验室指南数据库,供全球所有研究人员访问,支持开发新的HBV感染动物模型。

 

国际消除HBV联盟(ICE-HBV)简介

ICE-HBV是一个国际研究型平台,正在努力协调、促进及建立公私合作伙伴关系,以加快慢性乙肝(CHB)治愈方法的发现。其目标是促进发现一种安全、有效、经济实惠且可扩展的治愈方法,使所有CHB患者,包括儿童与合并感染丙型肝炎、丁型肝炎和艾滋病病毒(HIV)的人都能受益。ICE-HBV试图促进CHB这一公共卫生威胁的消除。ICE-HBV是一项非营利性倡议,最初于2016年由来自法国国家艾滋病与病毒性肝炎研究署(ANRS)、彼得·多尔蒂感染与免疫研究所(Peter Doherty Institute for Infection and Immunity)和国际乙型肝炎病毒会议(International HBV Meeting)的学术研究人员制定。ICE-HBV的成员(包括个人和机构)数量日增,现已遍布全球各地。

1. 促进全球乙肝治愈研究方面的合作

Webinar – A Global Scientific Strategy to Cure Hepatitis B

POSTED ON: 19 Jun, 2019

HBV is a global public health challenge on the same scale as tuberculosis, HIV, and malaria. More than 257 million people worldwide are chronically infected with HBV and nearly 900,000 people died from the disease in 2017.

During this session, panelists discusssed the International Coalition to Eliminate HBV (ICE-HBV) and how a global scientific strategy lays the groundwork for the momentum behind hepatitis B cure research and the long-term implementation of HBV cure preparedness worldwide.

Report Back from the HBV Cure Think Tank in Vienna (April 2019)

POSTED ON: 24 Apr, 2019

Professor Anna Lok presenting current data on HBV cure endpoints.
Professor Anna Lok presenting current data on HBV cure endpoints.

Hepatitis B cure is the next frontier in both liver disease and infectious diseases, and it is getting closer.

Cautious optimism is allowed as many new drugs are entering the pipeline and investments are growing since the entry receptor for HBV was discovered in 2015.

Still, many of these regimens might only induce remission as they might not eliminate viral cccDNA (covalently closed circular DNA – a special DNA structure that arises during the propagation of HBV in the cell nucleus and may remain permanently there).

Almost 500 packed the auditorium for the Think Tank, with the main topics of discussion including endpoints of cure, novel biomarkers, current immunology and virology-based approaches for cure, and considerations for combination therapies.

Professor Anna Lok (University of Michigan and ICE-HBV) gave a great summary of current data on HBV cure endpoints; Dr Barbara Testoni (Inserm Lyon and ICE-HBV) talked about how to impact cccDNA and Professor Mala Maini‘s talk (Imperial College London and ICE-HBV) focused on immunological strategies for HBV cure.

Better in vitro and in vivo models are required to ensure that a cure is soon discovered.

ICE-HBV is supporting this by collaborating with NIAID on a future reagent’s repository of HBV materials and an open access protocols dabatase soon available on www.ice-hbv.org.

ICE-HBV will also hold a workshop on in-vivo models in Melbourne in October 2019, stay tuned!

You can find out more on the next steps towards a cure in the “Global Scientific Strategy for an HBV Cure” released by ICE-HBV following a two-year in depth consultation process with key experts from the field, patient representatives and other stakeholders of the response to the hepatitis B epidemic.

See the webcast from the announcement here.

A Global Scientific Strategy to Cure Hepatitis B – Relevant Documents

POSTED ON: 10 Apr, 2019
ICE-HBV Scientific Strategy Launch – 10 April 2019