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).
The pharmacovigilance process was the same for all patients, regardless of participation in the endTB Observational Study. Safety data collection started at time of first bedaquiline or delamanid dose in the frame of endTB. Patients were followed until the end of treatment or until the end of the project, whichever came first. Pharmacovigilance data were shared with the relevant stakeholders including National TB Programs, national PV/aDSM, WHO, and drug manufacturers, per applicable regulations or agreements. Periodic Safety Reports, which aggregated and summarized safety data approximately quarterly, are available on request from the MSF pharmacovigilance unit (PV unit). The PV unit was established in 2015 and hosted by MSF.
This report describes the pharmacovigilance procedures and all fatal and life-threatening SAEs reported in endTB patients and that occurred between 1 April 2015 and 31 March 2019.