Who Consolidated Guidelines On Drug Resistant Tuberculosis Treatment

Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present 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.

BACKGROUND: Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). WHO estimates that about half a million cases of multi-drug or rifampicin resistant (MDR/RR-TB) are estimated to occur each year. However, only one third were estimated to have accessed effective treatment and of those, just over half had a successful treatment outcome. Therefore, there is a pressing need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment fulfills the mandate of WHO to inform health care professionals in Member States on how to improve treatment and care for patients with DR-TB. The 2020 recommendations on drug resistant TB treatment are contained in the second module to be released under the rubric of WHO Consolidated Guidelines on Tuberculosis (Module 4: Treatment). The WHO Consolidated Guidelines on Tuberculosis will group all TB recommendations in one document and will be complemented by matching modules of a consolidated operational handbook. The operational handbook will provide practical advice on how to put in place the recommendations at the scale needed to achieve national and global impact. OVERVIEW: Between 2011 and 2019, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO Consolidated Guidelines on Drug Resistant Tuberculosis Treatment, issued by WHO in March 2019. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups, using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment includes a comprehensive set of WHO recommendations for the treatment and care of DR-TB. The document includes two new recommendations, one on the composition of shorter regimens and one on the use of the BPaL regimen (i.e. bedaquiline, pretomanid and linezolid). In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB and MDR/RR-TB, including longer 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), the use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care. The guidelines are to be used primarily in national TB programmes, or their equivalents in Ministries of Health, and for other policy-makers and technical organizations working on TB and infectious diseases in public and private sectors and in the community.

Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present 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.

With the availability of new emerging evidence on the treatment of drug resistant TB (DR-TB), the WHO has recently updated the DR-TB treatment guidelines by convening a guideline development group meeting in 2019 and then by releasing the WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment in June 2020. These guidelines include a comprehensive set of WHO recommendations, grouping all new and existing recommendations on the treatment and care of DR-TB in one document. The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.

The WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Tuberculosis Care and Support informs health care professionals in Member States on how to improve treatment and care for patients with TB. These guidelines group all recommendations on TB care and support in one document and are complemented by an operational handbook. The guidelines are to be used primarily by national TB programmes, or their equivalents in Ministries of Health, stakeholders and technical organizations working on TB care in the public and private sectors and in the community.

The WHO consolidated guidelines on tuberculosis. Module 2: screening – systematic screening for tuberculosis disease is an updated and consolidated summary of WHO recommendations on systematic screening for tuberculosis (TB) disease, containing 17 recommendations for populations in which TB screening should be conducted and tools to be used for TB screening. TB screening is strongly recommendations for household and close contacts of individuals with TB, people living with HIV, miners exposed to silica dust, and prisoners. In addition, screening is conditionally recommended for people with risk factors for TB attending health care, and for communities with risk factors for TB and limited access to care (e.g. homeless, urban poor, refugees, migrants). General population screening is recommended in high-burden settings (0.5% prevalence or higher). Symptoms, chest radiography (CXR), and molecular WHO-recommended rapid diagnostic tests for TB are recommended as screening tools for all adults eligible for screening. Computer-aided detection programmes are recommended as alternatives to human interpretation of CXR in settings where trained personnel are scarce. For people living with HIV, C-reactive protein is also a good screening tool. This guideline document is accompanied by an operational handbook, the WHO operational handbook on tuberculosis. Module 2: screening – systematic screening for tuberculosis disease, that presents principles of screening, steps in planning and implementing a screening programme, and algorithm options for screening different populations.

The political declaration of the first United Nations (UN) high-level meeting on tuberculosis (TB) calls countries to diagnose and treat 40 million people with TB globally between 2018 and 2022. Traditionally, in most countries, TB diagnosis has been performed using sputum-smear microscopy, a method developed more than 100 years ago, with suboptimal sensitivity. In recent years new technologies have emerged based on the detection of mycobacterial DNA or mycobacterial antigens. Over the past decade the World Health Organization (WHO) has published a number of guidelines developed by WHO-convened Guideline Development Groups (GDGs), using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to summarize the evidence and to formulate policy recommendations and accompanying remarks. The present document "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" consolidates five guidelines developed by WHO between 2016 and 2020. Earlier guidelines on diagnostics that were not developed according to the GRADE approach have not been included in this document. The WHO Consolidated Guidelines on Tuberculosis will group all TB recommendations in one document and will be complemented by matching modules of an operational handbook. The handbook will provide practical advice on how to put in place the recommendations at the scale needed to achieve national and global impact. A range of new diagnostic technologies have been endorsed by WHO during the past decade. These are listed below: - real-time polymerase chain reaction (PCR) assays - for example, Xpert MTB/RIF(r) (Ultra) (cartridge-based) and TruenatTM (chip-based);- line probe assays (LPAs) - for example, GenoType(r) MTBDRplus v1 and v2, GenoscholarTM NTM+MDRTB II and GenoType(r) MTBDRsl;- loop-mediated isothermal amplification (LAMP) - for example, TB-LAMP; and- antigen detection in a lateral flow format (biomarker-based detection) - for example, Alere DetermineTM TB LAM Ag. The present "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" provides background, justification and recommendations on these technologies. The document includes new recommendations on molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children.