Tuberculosis Control: WHO Perspective and Guidelines
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TB is an old disease that was once a death sentence. Effective drug treatments first became available in the 1940s, and in combination with social and economic development they allowed countries in western Europe, North America and some other parts of the world to reduce their burden of TB disease to very low levels. For most countries, however, the “end” of TB as an epidemic and major public health problem remains an aspiration rather than a reality.
On 26 September 2018, the United Nations (UN) held its first ever high-level meeting on tuberculosis (TB) in New York. The title of the meeting – United to End TB: An Urgent Global Response to a Global Epidemic – highlighted the need for immediate action to accelerate progress towards the goal of ending the TB epidemic by 2030.
All Member States of WHO and the UN have committed to providing diagnosis and treatment with the aim of successfully treating 40 million people with TB from 2018 to 2022, including 3.5 million children, and 1.5 million people with drug-resistant TB; Along with this, preventing TB for those most at risk of falling ill, through the rapid scaling up of access to testing and provision of preventive treatment, so that at least 30 million people receive preventive treatment by 2022, with specific targets for children, household contacts and people living with Human Immunodeficiency Virus (HIV).
Specific targets for 2030 set in the End TB Strategy are a 90% reduction in the absolute number of TB deaths and an 80% reduction in TB incidence (new cases per 100,000 population per year), compared with levels in 2015.
Worldwide, TB remains one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). In 2017, TB caused an estimated 1.3 million deaths among HIV-negative people and an additional 300,000 deaths from TB among HIV-positive people. Globally, an estimated 10.0 million people (range, 9.0–11.1 million) developed TB disease in 2017 including 1.0 million children - of these, only 6.4 million cases were reported.
Drug-resistant TB continues to be a public health crisis. Worldwide, in 2017, about 558,000 people (range, 483,000–639,000) developed TB that was resistant to rifampicin (RR-TB), the most effective first-line drug, and of these, 82% had multidrug-resistant TB (MDR-TB). However only 160, 684 cases of MDR/RR-TB were detected and notified. The gap in India is also significant and large numbers of children are probably never detected to have MDR-TB.
About 1.7 billion people, 23% of the world’s population, are estimated to have a latent TB infection, and are thus at risk of developing active TB disease during their lifetime. The main health-care interventions to prevent new infections of Mycobacterium tuberculosis and their progression to TB disease are treatment of latent TB infection and vaccination of children with the Bacille Calmette-Guérin (BCG) vaccine. TB preventive treatment for a latent TB infection is expanding, but most of those for whom it is strongly recommended are not yet accessing care, e.g., the number for children aged under 5 y who received TB preventive treatment in 2017 were 292,182, only around 23% of the 1.3 million estimated to be eligible. The coverage of BCG vaccination is high globally.
The Sustainable Development Goals (SDG) and End TB Strategy targets set for 2030 cannot be met without intensified research and development. Technological breakthroughs are needed by 2025, so that the annual decline in the global TB incidence rate can be accelerated to an average of 17% per year.
The End TB Strategy milestones can only be achieved if TB diagnosis, treatment and prevention services are provided within the context of progress towards universal health coverage (UHC), and if there is multisectoral action to address the social and economic factors that drive TB epidemics. TB incidence needs to be falling at 10% per year by 2025, and the proportion of people with TB who die from the disease needs to fall to 6.5% by 2025 (current 16%).
Such levels have only been achieved in the context of UHC, combined with social and economic development that reduces known risk factors for TB infection and disease. UHC means that everyone – irrespective of their living standards – receives the health services they need, and that using health services does not cause financial hardship. SDG target 3.8 is to achieve UHC by 2030.
A 2017 WHO/World Bank report on UHC found that at least half of the world’s population lacks access to essential health services and almost 10% experience catastrophic expenditures on health. All of the 30 high TB burden countries need to increase service coverage and reduce levels of catastrophic expenditures to reach UHC, consistent with findings from surveys of costs faced by TB patients and their households.
Many new cases of TB are attributable to undernourishment, HIV infection, smoking, diabetes and alcohol use. A recent modelling study shows that eliminating extreme poverty and providing social protection could substantially reduce TB incidence. TB is not only a biomedical and a public health problem but also a disease associated with poverty; TB will continue thriving as long as poverty persists. The WHO End TB Strategy, whose aim is to end the TB epidemic, therefore combines a holistic mix of health and social interventions and requires implementation of a mix of biomedical, public health target and socioeconomic interventions along with research and innovation.
new tools – a point-of-care test for diagnosing infection and disease;
shorter and better regimens to treat disease and infection; and, ideally, a pre- and post-exposure vaccine;
closing gaps in TB diagnosis, treatment and prevention within the context of progress towards UHC;
multisectoral efforts to address the social and economic determinants and consequences of TB;
intensified TB research and development and
strengthened accountability using a framework to track and review progress towards commitments and actions needed to end TB at global, regional and national levels;
Increased and sustained funding, including from domestic sources (especially in middle-income countries), international donors and public–private partnerships.
The table below provides the most recent WHO guidance on this topic.
End TB Accelerator package.
WHO Consolidated Guidelines on Drug-Resistant Tuberculosis Treatment: 2019
Between 2011 and 2018, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. The 2019 Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents.
The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, including longer and shorter regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.
Further based on the most recent available evidence (individual patient data from ongoing trials), signal an important departure from previous approaches to treat MDR/RR-TB.
• Injectable agents are no longer included as priority medicines when constructing MDR-TB treatment regimens and fully oral regimens are now recommended as preferred option in most patients.
• Fluoroquinolones (levofloxacin or moxifloxacin), bedaquiline and linezolid are strongly recommended for use in longer regimens
• The shorter MDR-TB regimen may be offered to eligible patients who agree to a briefer treatment that may, however, be less effective than an individualized longer regimen and that requires a daily injectable agent for at least 4 months.
• Regimens that vary substantially from the recommended composition and duration (e.g. a standardized 9–12 months shorter MDR-TB regimen in which the injectable agent is replaced by bedaquiline) can be explored under operational research conditions.
• The recommendations apply generally to children and adults.
• Bedaquiline may now be given to children aged 6 years and more and delamanid from 3 years of age.
• Patient-centred support for medication adherence and active TB drug safety monitoring and management (aDSM) are essential for anyone starting an MDR-TB regimen.
Latent TB Infection: Updated and Consolidated Guidelines for Programmatic Management- 2018
Provide a comprehensive set of WHO recommendations for programmatic management of LTBI and the basis and rationale for national guidelines. They supersede previous WHO policy documents on the management of LTBI in people living with HIV and household contacts of people with TB and other at-risk groups. These guidelines for the first time recommend systematic testing and treatment of latent TB among household contacts of TB patients more than 5 years of age and shorter rifamycin based preventive treatment regimen in high TB burden countries (3HP, 3RH)
WHO Guidelines on Tuberculosis Infection Prevention and Control, 2019 Update
These guidelines outline a new evidence-based framework that promotes the implementation of an integrated package of Infection Prevention & Control (IPC) interventions based on administrative, engineering, and respiratory protection controls.
The interventions presented in these guidelines are not new, they replicate those described in earlier WHO guidelines but it provides spectrum of measures as a “package” of interventions. These updated guidelines continue to emphasize the need to implement the hierarchy of infection control as a systematic and complex approach for strengthening IPC and reducing the risk of M. tuberculosis transmission. In particular, they draw attention to the core components of IPC as a set of essential elements (i.e., core components) or minimum IPC standards that should be implemented across settings and across the various levels of care, for the effective and efficient functioning of IPC activities and practices.
Guidelines for Treatment of Drug-Susceptible Tuberculosis and Patient Care (2017 Update)
Contains policy recommendations on priority areas in the treatment of drug-susceptible TB and patient care. The main highlights are:
• The category II regimen is no longer recommended for patients who require TB retreatment and drug-susceptibility testing should be conducted to inform the choice of treatment regimen;
• The use of adjuvant steroids is recommended in the treatment of tuberculous meningitis and pericarditis;
• Recommendations on the provision of individual or a package of interventions on patient care and support, including patient or staff education, material support, psychological support, and tracers;
• Recommendations on the use of digital health interventions such as SMS or phone call as an tracer option), medication monitor, and video observed treatment (VOT – as a replacement for in-person directly observed treatment - DOT) when conditions of technology and operation allow;
• Recommendations on the effective treatment administration options: community or home-based DOT, and DOT administered by trained lay providers or health-care workers; and
• Decentralized model of care is recommended over centralized model for patients on MDR-TB treatment.
Compendium of WHO Guidelines and Associated Standards: Ensuring Optimum Delivery of the Cascade of Care for Patients with Tuberculosis
Second Edition - June 2018
The Compendium has been developed as a clear and concise instrument to facilitate the understanding and planning of delivery of high-quality care for everybody affected by TB. It incorporates all recent policy guidance from WHO; follows the care pathway of persons with signs or symptoms of TB in seeking diagnosis, treatment and care; and includes key algorithms and cross-cutting elements that are essential to a patient-centered approach in the cascade of TB care.
Chest Radiography in Tuberculosis Detection
Summary of Current WHO Recommendations and Guidance on Programmatic Approaches (2016)
Provides consolidated summary of WHO recommendations on the use chest radiography in TB detection and guidance on programmatic approaches.
The document provides guidance in the following areas:
• Chest radiography as a triage tool.
• Chest radiography as a diagnostic aid.
• Chest radiography as a screening tool.
• Technical specification, quality assurance and safety.
• Strategic planning for use of chest radiography in national TB control.
The document also describes new technological developments in chest radiography, such as computer aided detection of TB that holds promise for future use but needs to be further evaluated before WHO guidance is developed.
Public–Private Mix for TB Prevention and Care: A Roadmap > 2018
Identifies clear actions needed to expand the engagement of all care providers towards universal access to care
Roadmap Towards Ending TB in Children and Adolescents > 2018
Armed with new knowledge about how 10% of all TB affects and manifests in children under 15 years of age, the roadmap provides clear vision of what is needed, how to deliver it – and the priority actions and enhanced investments that are urgently required.
Handbook for the Use of Digital Technologies to Support Tuberculosis Medication Adherence
It focuses specifically on three technologies that are being widely used to help TB patients complete their treatment over the many months that their regimens last
• short message service (SMS),
• medication event monitoring systems (MEMS) and
• video-supported treatment (VOT)
It details the main elements that the programme manager or other end-user needs to think through at different stages of implementation.
Update to 2018 WHO LTBI guidelines to consider two more shorter rifamycin based preventive treatment regimen (2019).
Update to WHO guidelines on Systematic screening for active tuberculosis (2020).
Update to WHO guidelines on diagnostics e.g., use of newer Urine LAM, tests for detection of latent TB (2020).