Sessions

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Study 31/A5349 is a phase III randomised controlled non-inferiority trial to evaluate the efficacy and safety of two, four-month regimens with high-dose rifapentine with or without moxifloxacin for the treatment of drug-sensitive tuberculosis (TB). The trial is a collaboration between the TB Trials Consortium (TBTC) and the Adult AIDS Clinical Trials Group (ACTG).  In this symposium, we will present the trial design and results of the primary 12-month analysis. In addition, presentations will discuss safety of the short regimens, selected secondary and sensitivity analyses, local medical and community perspectives, plus lessons learned and next steps.

16:30 - 16:35: Introduction

16:35 - 16:45: The design and primary efficacy results of Study 31/A5349In this talk the design and the efficacy results for Study 31/A5349, a randomised, open-label, controlled phase 3 trial, will be presented. The trial’s primary efficacy endpoint is tuberculosis (TB) disease-free survival at 12 months after study treatment assignment. A total of 2,516 participants, from 33 sites in 13 countries, were enrolled. The proportion of participants, who are culture-negative at eight weeks, and time to stable sputum culture conversion (on solid and liquid media) will also be reported.
Susan Dorman

16:45 - 16:55: Safety of high-dose rifapentine regimensThis talk will review safety data of the two high-dose rifapentine regimens. The proportion of participants with grade 3 or higher adverse events during study drug treatment will be described. Rates of discontinuation of assigned treatment for a reason other than microbiological ineligibility, will be reported. All-cause mortality, including all deaths from any cause during treatment or follow-up up, will be described with primary cause of death reported by the regimen. The presentation will also include suggestions for safety monitoring and patient management for the short regimen in programmatic settings.
Ekaterina Kurbatova

16:55 - 17:05: Secondary efficacy and safety analyses of short regimen performance by disease phenotypes and patient subgroupsKnown risk factors for relapse and treatment failure include extensive cavitation, higher smear grade, low BMI and a compromised immune system because of HIV infection or uncontrolled diabetes. This talk will review results of secondary analyses that further explore the efficacy and safety of the short regimens, highlighting particular groups of patients that experienced the most benefit.
Payam Nahid

17:05 - 17:15: Perspectives on shortened TB regimens: local medical and community viewsThis talk will focus on local medical and community perspectives considering the promise, value-add and possible challenges and solutions to implementation of short tuberculosis regimens. These will be considered in a specific country setting, contextualising the findings.
Grace Muzanye

17:15 - 17:25: Lessons learned and next stepsThis talk will discuss lessons about inclusion of adolescents and HIV-positive individuals with CD4 count threshold of 100 cell/mm3, adherence, regional differences, a novel 'possible poor treatment response' process for endpoint ascertainment, and the value of standardised laboratory techniques. Relevant future actions will be considered.
Richard Chaisson

17:25 - 17:50: Q&A session

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The World Health Organization, in collaboration with the European Respiratory Society, formulated a framework towards the elimination of TB in 33 counties with currently low TB incidence, to be achieved by 2050. The symposium provides the stage for a pro/con discussion on the feasibility of this framework. It addresses the current state of affairs around some of the key priorities stated in the framework as being instrumental to reach TB elimination in low-incidence counties. These include the care for vulnerable groups, dealing with cross-border health seeking and investments in research and new tools for diagnosis and prevention.

16:30 - 16:35: Introduction

16:35 - 16:45: Mission possible: TB elimination in EuropeThe European Union (EU) and European Economic Area (EEA) observes a decline in tuberculosis (TB) notification rate of about 5% per year. This is not enough to reach TB elimination or a reduction of the TB incidence rate of 80% by 2030 (SDG target).  The too slow decrease of TB incidence is partly due to the increasing percentage of TB cases in migrants; in many EU/EEA countries with a low TB notification rate, >75% of TB cases are among migrants. Cases in migrants need to be diagnosed and treated but may be hard to prevent if infection occurred outside of the EU/EEA. Therefore, elimination can be better defined as no local transmission as measured by whole genome sequencing. By using whole genome sequencing data (EU/EEA wide and from selected countries) the potential for TB elimination will be presented and challenges identified.
Marieke van der Werf

16:45 - 16:55: Mission impossible: TB elimination in EuropeProjecting the incidence data of tuberculosis (TB) from the past decade into the future, suggests that elimination of TB in the European Union/European Economic Area (EU/EEA) might be achieved by 2035. However, in a globalised world, elimination of TB in the EU/EEA appears unlikely and even if this unlikely scenario were to happen, the elimination of TB in Europe would still be far out of reach. Only a small fraction of patients with TB in Europe live in the EU/EEA. Some countries in central and eastern Europe still have a high incidence of TB and central/eastern Europe is one of the hotspots of multidrug-resistant/rifampicin-resistant TB globally. The obstacles on the way to elimination are in all areas: prevention, diagnosis and treatment. Without a vaccine that protects contacts of patients with TB from the development of TB, elimination of TB will not be achieved, neither in Europe nor anywhere else.
Christoph Lange

16:55 - 17:05: Translational research and new tools in the pipeline to eliminate TB in low burden countriesTuberculosis (TB) elimination in low burden countries requires a comprehensive effort with existing and new tools. This presentation will familiarise the audience on recent diagnostic innovations in the pipeline to improve active case finding, infection detection and prediction of risk.
Morten Ruhwald

17:05 - 17:15: Access to care for vulnerable populations in EuropeTuberculosis (TB) burden in Europe is particularly high among vulnerable population groups. These groups also have an increased risk of inadequate access to diagnosis and treatment results. This is why access to healthcare for vulnerable groups, including migrants, is both important for individual care of patients and to ensure a reduction of transmission that would be necessary for TB elimination in Europe. Here, we will discuss 1) current evidence on access of care for vulnerable population groups in Europe; 2) evidence on strategies and policies effective at increasing access to care and lowering transmission of TB, and 3) some considerations on ethics, equity and legal issues in the design of these policies
Berit Lange

17:15 - 17:25: Research collaborations informing TB control strategies in Europe: TBnet and ERS-CRC approachTBnet has performed a large number of clinical and operational studies in the field of tuberculosis (TB). The consortium is supported by the European Respiratory Society, through a clinical research collaboration. The activities provided insight in - amongst others - the unequal distributions across Europe in terms of infection control facilities, the staff available, and inpatient vs. outpatient management of TB, the inclusion of 'hard to reach' groups, the cost and availability of molecular diagnostic tests for multidrug-resistant TB, the availability, cost and stability of drug supply, the adverse effects of new drugs, and the confounding effect of relapse on treatment outcomes.  
Graham Bothamley

17:25 - 17:50: Q&A session

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Management of mild asthma has for a long time been unsatisfactory and the treatment of mild asthma has not been tested in clinical trials. The use/overuse of short-acting beta-2 agonist (SABA) alone in patients treated as mild asthmatics has become a concern and the association with severe adverse events has become clear. Access adherence with regular inhaled corticosteroid (ICS) treatment is a major issue in this population. The rationale efficacy of treatment with as needed ICS and rapid acting bronchodilator will be discussed in this session.

Learning Objectives:

Review concerns associated with the use of rescue SABA in the absence of maintenance treatment.

Discuss the merits of as-needed ICS treatment strategies in mild asthma in adults and children.

16:30 - 16:35: Introduction

16:35 - 16:47: GINA 2019: a fundamental change in asthma managementNew recommendations about the treatment of mild asthma, published by the Global Initiative for Asthma (GINA) in early 2019, have been described as the most fundamental change in asthma management in 30 years. These recommendations represented the culmination of a decade-long campaign by GINA to develop new strategies for mild asthma with the aim of reducing asthma morbidity and mortality, particularly in low-resource countries. They were prompted by concerns about the risks and consequences of treating mild asthma with short-acting beta2-agonists alone. This presentation will describe the background to the changes, the evidence obtained from large, new clinical trials and observational studies which provided the basis for the new GINA recommendations, the issues and priorities that were taken into account, and the global challenges and evidence gaps that remain.
Helen Reddel

16:47 - 16:59: As-needed use of ICS and SABA in separate inhalers? Applicability to childrenOne of the more frequent issues in difficult asthma in children is adherence. Using inhalers only when they are needed could be a good way to improve adherence and control. This presentation would update the evidence on the efficacy of treating asthma in children using as needed combination of short-acting beta-2 agonists and corticosteroids combined in the same inhaler, as compared to the standard approach in GINA guidelines. If this is approach is safe and effective in children, as well as being more affordable, it should be seriously considered.

Luis Garcia-Marcos

16:59 - 17:11: Combination inhaler (ICS/ formoterol) applicability to children: a low- resource setting perspective.Asthma in children is increasing in prevalence in children in low- and middle-income countries. Risk factors for this increase and poor asthma control in this population are poorly studied. One of the critical gaps in asthma treatment is access to affordable and safe medication delivered via an appropriate delivery system. The current Global Initiative for Asthma recommendations encourage the use of combination therapy to improve asthma control, but this may not be possible in settings where there is poor access to spacer delivery systems and unaffordability of drugs. Motivation for one drug device to manage asthma is an attractive option in this setting where there is an overuse of short-acting beta-agonist, together with interventions and advocacy, to improve access to asthma treatment and this may be a solution to this issue in low-income settings.
Refiloe Masekela

17:11 - 17:23: Obtaining optimal control of asthma in resource-limited settings: theory and practiceThe management of asthma requires medicines relaxing airway smooth muscles and reducing airway inflammation. Rapid-acting b2 agonist does not effectively address the underlying problem of airway inflammation. Excess use of inhaled bronchodilators alone for symptom relief may result in a delay in seeking health care. Inhaled corticosteroid (ICS) is critical in the treatment of airway inflammation but is underused. A substantial proportion of patients with persistent asthma in resource-limited settings have no access to affordable ICS for long-term treatment. Studies have shown that the use of both ICS and rapid-acting b-agonist as needed for symptom relief might be a better option.
Chen-Yuan Chiang

17:23 - 17:50: Q&A session

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In this session recent insights into the host immune response to M. tuberculosis infection will be discussed. The results from a first tuberculosis (TB) biomarker guided clinical trial will be reported and discussed in the context of TB risk and targeted interventions. The role of innate trained immunity will next be reviewed and discussed, including in the context of BCG vaccination. The emerging role of antibodies in TB will be reviewed as well. The three keynote presentations will be followed by the selected abstract presentations and close with an open panel discussion.


17:20 - 17:45: Panel discussion

Thomas Scriba
Reinout van Crevel
Galit Alter
Ann Ginsberg

17:45 - 18:05: Live Q&A

Thomas Scriba
Reinout van Crevel
Galit Alter
Ann Ginsberg

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Session Organised by: German Central Committee against Tuberculosis (DZK)

„History of The Union”
The centennial of The Union is a good opportunity to look back on some aspects of its long history. Since it is not possible in the allotted time to recognize all other important organizations worldwide, which are linked to The Union including their African, Asian-Pacific and South American Regions, the session has to concentrate on a few others. It is moderated by Dean Schraufnagel, former member of the Board of Directors of The Union and Past President of the ATS.
Since the Centennial of The Union coincides with the 125th anniversary of the German Central Committee against Tuberculosis (DZK), this year's Robert Koch Lecture provides a good opportunity for Robert Loddenkemper, Past President of DZK, of the Europe Region of The Union and of the ERS, to underline the close relationship of the DZK with The Union. The Robert Koch Lecture was initiated by Rudolf Ferlinz, Secretary General of DZK and President of the Union, at the 1994 World Conference in Mainz/Germany. Since 1994 six Robert Koch Lectures have been given by prominent TB experts at The Union World Conferences.
The roots of the Union are going back to the International TB Congress in Berlin 1902, where an "International Central Bureau for the Fight against Tuberculosis" was established, which can be seen as predecessor of The Union. It had the headquarters in Berlin, and Gotthold Pannwitz, Secretary General of DZK, took over the management of the bureau and of the international monthly journal "Tuberculosis". In 1895, Pannwitz was also the main initiator of the foundation of the “German Central Committee for the Establishment of Sanatoria”, one of the oldest national TB organizations worldwide. In 1905 the name of the Committee was changed to “…for the Fight against Tuberculosis". Out of this reason Robert Koch, being critical of the sanatorium movement, finally accepted to join the Committee.
Periodic international conferences systematically addressing clinical, research, and sociological aspects of TB were held until the outbreak of World War I in 1914. After the war, in 1920, a conference on TB was convened in Paris, at which the International Union Against Tuberculosis (IUAT) was founded. Until 1939, ten international conferences followed, the 11th Conference was planned to take place in Berlin in September 1939, but had to be cancelled because WW II was started by Germany on 1ST September. When the Nazis came into power in January 1933, a very dark chapter in TB control started under the general health-related motto “Public interest comes ahead of self-interest”. The horrible consequences for TB patients are described in detail. In June 1940, after the occupation of Paris, the Nazis closed the IUAT Office, which was reopened again after the war, in 1946.
During World War II, TB mortality had increased steeply in many belligerent and non-belligerent countries. This induced a broad international cooperation. Mario Raviglione, year-long former Director of the Global TB Programme at the WHO, describes in the second lecture, how the WHO was officially established by the UN in 1948, when malaria, TB, and venereal diseases were declared as the “3 main scourges demanding prior and special attention”. Just from the beginning, the Executive Committee established for TB a close relationship with the IUAT, the beginning of a very fruitful cooperation. In the mid-1960s, the Tuberculosis Surveillance Research Unit (TSRU) with The Union and the WHO as important members was initiated by KNCV. The results of the annual meetings were published in several guidelines/reports on Drug Resistance, which are now incorporated into the annual Global TB Reports of the WHO.  With the advent of HIV in the mid-1990s, the collaboration was intensified. The concept on DOTS, developed by Karel Styblo, Executive Director of The Union, was promoted by the WHO as a new strategy for TB control. There were many other fields of close cooperation, amongst them the World TB Day initiated in 1982 by The Union and later recognized officially as an annual event by the WHO.
Philip Hopewell, former President of the North American Region of The Union and of the ATS, describes in the third lecture the long and close relationship of the North American organizations from Canada und USA with The Union. The North American Region of The Union was founded in 1990. North American organizations with “informal” but influential relationships with The Union are United States Agency for International Development (USAID), the US Centers for Disease Control and Prevention (CDC), many academic institutions in US and Canada and NGOs (FHI 360, MSH, PATH). Lobbying effort for funding of global TB control were initiated by ALA/ATS in 1992. ALA/ATS convened advisory groups including the Union and the Tuberculosis Coalition for Technical Assistance (TBCTA), which was founded in 2000 at the request of USAID and original partners (The Union, WHO, CDC, KNCV, ALA/ATS). Between 2000-2019 USAID alone funded more than 900 Million USD for TB control.
In the last lecture, Giovanni Battista Migliori, Past President of the Europe Region of The Union, former ERS Secretary General and at present Chair of the Global TB Network and one of the two Chief Editors of the IJTLD, describes mainly the many activities in Europe during the last thirty years. The Europe Region of The Union was founded only in 2002 with the particular aim to increase the collaboration between Western and Eastern Europe, the latter with its high TB incidences and frequent drug resistances (MDR-TB). European organizations, which had been active already before, are WHO-Europe, KNCV, The Union and the ERS. All supported the two-yearly conferences of the Europe Region in Budapest, Bucharest, Moscow, Riga, Dubrovnik, London and Bratislava. KNCV organizes since 1990 the Wolfheze Workshops, at which experts from low incidence countries developed basic TB principles and documents allowing Europe to equip itself with surveillance, policies and guidelines for TB control and elimination. In other initiatives the Europe Region collaborates closely with ERS, WHO-Europe, ECDC, EU and many national respiratory societies, also on topics like prevention of smoking and non-communicable diseases.

18:15 - 18:19: Introduction


18:19 - 18:42: Robert Koch lecture: the history of the German Central Committee against Tuberculosis and its close relationship with The Union

Robert Loddenkemper

18:42 - 19:01: The World Health Organization and its close relationship with The Union

Mario Raviglione

19:01 - 19:20: North American organisations and their close relationship with The Union

Philip Hopewell

19:20 - 19:39: European organisations and their close relationship with The Union

Giovanni Battista Migliori

19:39 - 19:43: Closing remarks

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Using existing and emerging digital technology to enhance virtual, remote and supportive patient care and management during and beyond COVID-19

Please note that the number of participants is limited to 50 for this session.

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Organised by: The United States Agency for International Development / Infectious Disease Detection and Surveillance (IDDS) project

The tuberculosis (TB) diagnostic network assessment is an innovative, holistic and comprehensive way to assess a country's dedicated TB diagnostic network. It's a country driven activity which involves local and external TB experts. This joint activity assesses the functionality of a country's TB diagnostic, in line with the national strategic plan and the End TB strategy. This assessment and review will help the country to identify key gaps and recommendations as well as help to strengthen a comprehensive TB diagnostic network with strong underlying health systems. 

Target audience 1: Doctors, Nurses, Lab technicians
Target audience 2: Clinicians, TB programme managers, activists
Target audience 3: TB project managers, NGOs



18:15 - 18:20: Introduction


18:20 - 18:35: Improving TB diagnostic access by the TB diagnostic network assessment model The Tuberculosis (TB ) diagnostic network assessment (DNA) is a country driven process that assesses the functionality of the national TB diagnostic network and system. It helps in determining the system’s capacity to meet the needs of the country’s national TB strategic plan (NSP) for achieving the goals outlined in the End TB strategy. The TB DNA reviews, holistically, the diagnostic network and current practices and algorithms; identifies challenges that prevent the diagnostic network from performing efficiently and effectively and proposes evidence-based interventions to improve the overall ability of the diagnostic network to meet the goals and targets of the NSP.

Amy Piatek

18:35 - 18:50: The TB diagnostic network assessment tool presentation The use of an assessment tool, with semi-quantitative scoring, for the country to identify the stage of various aspects of the diagnostic network and to describe current capabilities and identify key areas for improvement. Verification of the self-assessed staging, using a set of standardised tools and checklists, and including site visits to a selection of sites. Conducted by an experienced group of international laboratory experts with support from in-country lab and TB experts.

Thomas Shinnick

18:50 - 19:05: TB diagnostic network assessment: data and spatial analysis The spatial TB diagnostic network analysis will be used to inform tuberculosis diagnostic network assessment (TB DNA) planning on a selection of regions to be assessed during the in-country visit  - brief the TB DNA teams about TB diagnostic network situation (coverage, access and effectiveness) prior to/at the beginning of the assessment visit; inform conclusions and support the development of recommendations by the TB DNA team during the assessment visit; develop baseline network scenarios, which can be refined during the TB DNA in-country visit, based on findings and assumptions for additional diagnostic instruments, relocated instruments, altered specimen referral linkages or other.

Manuela Rehr

19:05 - 19:20: Infectious Disease Detection and Surveillance project support to countries on the TB diagnostic network assessment The Infectious Disease Detection and Surveillance (IDDS) project is currently working closely with countries’ national tuberculosis (TB) control programmes to reinforce TB and drug-resistant TB diagnostics for all eligible patients. The TB diagnostic network assessment (TB DNA) has already been conducted in India, Uganda and Zimbabwe. The upcoming countries for 2020 are Tanzania, Viet Nam and Bangladesh. We are also working with relevant stakeholders to conduct this assessment in Mozambique and Burma. The support from IDDS is based on the respect of human rights and that access to all these diagnostic technologies should be available, regardless of a population’s income or cultural, racial, gender, religious or ethnic inclination.

Inoussa Zabsonre

19:20 - 19:45: Q&A session

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Organised by: Cepheid

The overall objective of the session will support the audience to gain deeper insights on latest innovations in TB diagnostics. 
The panelists will walk through novel technologies to improve drug-susceptibility testing, host response concepts as well as clinical insights to leverage available diagnostic tools.
* CE-IVD. In Vitro Diagnostic Medical Device. Product not available in the United States.

18:15 - 18:25: Introduction


18:25 - 18:45: Behind the scenes – Innovations in TB diagnostics Dr. Gnanashanmugam will share insights about the innovation behind the Xpert® MTB/XDR assay* and Cepheid’s technology.

Devasena Gnanashanmugam

18:45 - 19:05: Evaluation of Xpert® MTB/XDR* and possibilities of integration into the National diagnostic algorithm – the South African perspective Dr. Omar will present the first clinical evaluation of the recently launched Xpert® MTB/XDR* assay in South Africa.
* CE-IVD. In Vitro Diagnostic Medical Device. Product not available in the United States.

Shaheed Vally Omar

19:05 - 19:25: Demonstrating the power of heterogeneity: from discovery to point-of-care using public data for tuberculosis diagnosis Dr. Khatri will speak about host response gene signatures in Tuberculosis and share further insights.

Purvesh Khatri

19:25 - 19:45: Using available TB diagnostics to Guide Patient Management – A Clinical Perspective Prof. Kon will share his experience as a clinical expert in how to leverage diagnostic tools for patient management.  
 

Onn Min Kon

This session takes place on Zoom.us

SeeChange works in close partnership with local communities and their organizations, such as Ilisaqsivik in Clyde River, Nunavut (ilisaqsivik.ca). 'Flattening the curve' of the COVID-19 pandemic in a particular setting requires the community to be front and centre in the development and implementation of essential activities. SeeChange and Ilisaqsivik have developed a practical tool called the 'CommunityFirst COVID-19 Roadmap' to assist communities in their planning and response to the threat of COVID-19 (www.communityfirstcovid19.org). This Roadmap offers a step-by-step guide for communities to create a plan to Organize, Prepare, Respond, and (just as importantly) Recover from COVID-19. During this webinar, utilization of the Roadmap tool will be described in detail by the Community Readiness Coordinator at SeeChange, with support from the Medical Director.

Jessica Farber, Community Readiness Coordinator, SeeChange Initiative 
Peter Saranchuk, Medical Director, SeeChange Initiative

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BCG protection against COVID-19

Please note that the number of participants is limited to 50 for this session.