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).

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. 

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.

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.

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.

endTB Observational Study had sites in 17 countries. In each country, sites enrolled patients on treatment with bedaquiline and delamanid according to National TB Program guidelines, while collecting clinical and bacteriological data on efficacy and safety. Because many of the endTB Observational Study tools were found to be useful for clinicians and programs that were starting to use the new TB drugs and regimens, we made them freely available at the endTB website.

Geneva, November 2018

Researchers from endTB participated in the WHO Global Consortium to share updated results and the study’s implementation practices, in addition to evidence to support the transition, operationalization, and scale-up of new MDR-TB guidelines. 

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

We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to standardised questionnaires and the Global TB Drug Facility website.

This report was produced with endTB's support.