endTB Clinical and Programmatic Guide for Patient Management with New TB Drugs

 

This guide is designed to give guidance to the endTB Project site on the use of new TB drugs bedaquiline and delamanid. It is intended to be a resource for physicians and other health care professionals involved in the endTB project. Every effort possible has been made to ensure that the material presented here is accurate, reliable, and in accord with current standards. However, as new research and experience expand our knowledge, recommendations for care and treatment change.

DR-TB Drugs Under the Microscope: 8th edition

This MSF Access Campaign report – the eighth in this series – examines the current landscape and trends of DR-TB drug pricing and patents, and highlights challenges and opportunities to accelerate people’s access to lifesaving regimens that are shorter, all-oral and make use of the most effective medicines. 

Publication: Safety and Effectiveness Outcomes From a 14-Country Cohort of Patients With Multi-Drug Resistant Tuberculosis Treated Concomitantly With Bedaquiline, Delamanid, and Other Second-Line Drugs

Background: Concomitant use of bedaquiline (Bdq) and delamanid (Dlm) for multi-drug/rifampicin resistant tuberculosis (MDR/RR-TB) has raised concerns about a potentially poor risk-benefit ratio. Yet this combination is an important alternative for patients infected with strains of TB with complex drug resistance profiles or who cannot tolerate other therapies. We assessed safety and treatment outcomes of MDR/RR-TB patients receiving concomitant Bdq and Dlm, along with other second-line anti-TB drugs.

Publication: All-oral longer regimens are effective for the management of multidrug resistant tuberculosis in high burden settings

Recent World Health Organization guidance on drug-resistant tuberculosis treatment de-prioritised injectable agents, in use for decades, and endorsed all-oral longer regimens. However, questions remain about the role of the injectable agent, particularly in the context of regimens using new and repurposed drugs. We compared the effectiveness of an injectable-containing regimen to that of an all-oral regimen among patients with drug-resistant tuberculosis who received bedaquiline and/or delamanid as part of their multidrug regimen.

Publication: Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

Background: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality evidence underpinning the recommendation.

Publication of the endTB Protocol in Trials

A comprehensive summary of the study protocol of the endTB clinical trial has been published in the peer-reviewed journal Trials. Below you will find the link to the open-access article.

 

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