endTB fatal and life-threatening SAE report

December 17, 2021

Report of fatal and life-threatening adverse events during endTB post-marketing safety surveillance of new and repurposed TB drugs

As part of the endTB project and observational study (2015-2019), rigorous post-marketing safety surveillance for all patients (referred to as "endTB patients") who began MDR/RR-TB regimens containing bedaquiline or delamanid was performed. This safety surveillance conformed to the "advanced" active TB Drug Safety Monitoring and Management (aDSM) package as defined by WHO (WHO/HTM/TB/2015.28).

Publication of the endTB Protocol in Trials

October 12, 2021

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.

 

The endTB COVID-19 Interim Guidance

November 25, 2020

This document is designed to give guidance to the endTB Project sites on the response to the COVID-19 outbreak. It is intended to be a resource for physicians and other health care professionals. It is a living document that will be regularly updated and enriched. 

DR-TB Drugs Under the Microscope: 7th edition

October 27, 2020

This MSF Access Campaign report – now in its seventh edition – covers recent developments, pricing and patent barriers for shorter treatment regimens for TB preventive therapy and newer TB medicines required for the optimal treatment of drug-resistant TB (DR-TB), including an update on pediatric DR-TB formulations.

endTB Study Group Members

December 8, 2019

The endTB Study Group is the group that is responsible for the endTB Observational Study (NCT02754765), which includes more than 2700 patients started on bedaquiline and delamanid containing regimens in 17 countries. Organized by country, this is a list of doctors, nurses, data managers, pharmacists, social workers, administrators and others who have spent many hours collecting and cleaning data, working closely with patients, and ensuring that the endTB Observational Study works smoothly in every aspect of its complex existence.

DR-TB Drugs Under the Microscope: 6th edition

November 7, 2019

This MSF Access Campaign report – now in its sixth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs in the framework of the new 2019 WHO DR-TB guidelines.

We provide detailed pricing profiles of key DR-TB drugs available on the Global TB Drug Facility website and estimated prices of DR-TB regimens recommended by WHO in programmatic or operational research frameworks.

This report was produced using among others endTB observational cohort data.

Technical Basis of the endTB Observational Study (EN/RU/ES/FR)

January 20, 2019

This Technical Basis document provides the rationale for clinical decision-making, screening tools, and data definitions that are used at the endTB Observational Study sites. This is a living document. If you would like to suggest an additional topic, please email us at [email protected]

The Technical Basis document is available in English, Russian, Spanish and French.

PIH MSF MSF UNITAID