The Use Of Bedaquiline In The Treatment Of Multidrug Resistant Tuberculosis

WHO estimates that up to half a million new cases of multidrug-resistant tuberculosis (MDR-TB) occur worldwide, each year. Current treatment regimens for MDR-TB present many challenges: treatment lasts 20 months or more, requiring daily administration of drugs that are more toxic, less effective, and far more expensive than those used to treat drug-susceptible TB. Globally, less than half of all patients who start MDR-TB therapy are treated successfully. For the first time in over 40 years, a new TB drug with a novel mechanism of action - bedaquiline- is available, and was granted accelerated approval by the United States Food and Drug Administration in December 2012. There is considerable interest in the potential of this drug to treat MDR-TB. However, information about this new drug remains limited. It has only been through two Phase IIb trials for safety and efficacy. The World Health Organization (WHO) is therefore issuing "interim policy guidance". This interim guidance provides advice on the inclusion of bedaquiline in the combination therapy of MDR-TB in accordance with the existing WHO Guidelines for the Programmatic Management of Drug-resistant TB (2011 Update).

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.

Some volumes for 2014 includes CD-ROM for 2014 key indicators.

The emergence of extensively drug-resistant strains of tuberculosis, especially in countries with a high prevalence of human immunodeficiency virus, is a serious threat to global public health and jeopardizes efforts to effectively control the disease. This publication offers updated recommendations for the diagnosis and management of drug-resistant tuberculosis in a variety of geographical, economic and social settings, and the recording of data that enables the monitoring and evaluation of programs.--Publisher's description.

This 2011 update of Guidelines for the programmatic management of drug-resistant tuberculosis is intended as a tool for use by public health professionals working in response to the Sixty-second World Health Assembly's resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolution WHA62.15, adopted in 2009, calls on Member States to develop a comprehensive framework for the management and care of patients with drug-resistant TB. The recommendations contained in these guidelines address the most topical questions concerning the programmatic management of drug-resistant TB: case-finding, multidrug resistance, treatment regimens, monitoring the response to treatment, and selecting models of care. The guidelines primarily target staff and medical practitioners working in TB treatment and control, and partners and organizations providing technical and financial support for care of drug-resistant TB in settings where resources are limited.

Chapter 1. Introduction -- chapter 2. Disease burden and 2015 targets assessment -- chapter 3. TB case notifications and treatment outcomes -- chapter 4. Drug-resistant TB -- chapter 5. Diagnostics and laboratory strengthening -- chapter 6. Addressing the co-epidemics of TB and HIV -- chapter 7. Financing -- chapter 8. Research and development -- Annexes.

This work contains updated and clinically relevant information about tuberculosis. It is aimed at providing a succinct overview of history and disease epidemiology, clinical presentation and the most recent scientific developments in the field of tuberculosis research, with an emphasis on diagnosis and treatment. It may serve as a practical resource for students, clinicians and researchers who work in the field of infectious diseases.

This book covers all aspects of the medicinal chemistry of the latest drugs, and the cutting-edge science associated with them. Following the editors’ 3 successful drug synthesis books, this provides expert analysis of the pros and cons of different synthetic routes and demystifies the process of modern drug discovery for practitioners and researchers. Summarizes for each drug: respective disease area, important properties and SAR (structure-activity relationship), and chemical synthesis routes / options Includes case studies in each chapter Illustrates how chemistry, biology, pharmacokinetics, and a host of disciplines come together to produce successful medicines Explains the advantages of process synthesis versus the synthetic route for drug discovery

Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) are increasingly encountered in resource-limited settings. In the context of a national response to MDR- and XDR-TB, health workers in TB clinics (in district hospitals and some accredited health centers) will need to diagnose MDR-TB, initiate second-line anti-TB drugs, and monitor MDR-TB treatment. This Field Guide was created to help health workers carry out these tasks. It is a job aid that medical officers and TB nurses are meant to use frequently during the day for quick reference. It is based on the Emergency Update 2008 of Guidelines for Programmatic Management of Drug-resistant Tuberculosis, and may be considered a companion document to these guidelines. It also draws on the experience of the international health NGO Partners In Health (PIH) in many countries. This module should be introduced to health workers in the context of a training course with a strong emphasis on TB-HIV co-management.