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Publication: Setting up pharmacovigilance based on available endTB Project data for bedaquiline

Active pharmacovigilance (PV) is recommended for TB programmes, notably for multidrug-resistant TB (MDR-TB) patients treated with new drugs. Launched with the support of UNITAID in April 2015, endTB (Expand New Drug markets for TB) facilitated treatment with bedaquiline (BDQ) and/or delamanid of >2600 patients in 17 countries, and contributed to the creation of a central PV unit (PVU).

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: Recently developed drugs for the treatment of drug-resistant tuberculosis: a research and development case study

endTB fatal and life-threatening SAE report

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).

  • endTB Observational Study

endTB Study Group Members

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.

  • endTB Observational Study
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