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Setting up pharmacovigilance based on available endTB Project data for bedaquiline.

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The endTB program established a central pharmacovigilance unit (PVU) to monitor serious adverse events (SAEs) in multidrug-resistant TB patients receiving bedaquiline (BDQ). This advanced system identified safety signals related to drug interactions and off-label use, demonstrating feasibility in routine care.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Tuberculosis Treatment
  • Clinical Pharmacology

Background:

  • Active pharmacovigilance (PV) is crucial for tuberculosis (TB) programs, especially for multidrug-resistant TB (MDR-TB) patients on new drugs.
  • The endTB initiative, supported by UNITAID, facilitated the use of bedaquiline (BDQ) and/or delamanid for over 2600 patients across 17 countries.
  • A central PV unit (PVU) was established to manage and analyze safety data.

Purpose of the Study:

  • To detail the pharmacovigilance unit (PVU) process within the endTB initiative.
  • To describe serious adverse events (SAEs) observed in patients treated with bedaquiline (BDQ)-containing regimens.
  • To identify safety signals associated with new TB drugs.

Main Methods:

  • Implemented an advanced TB drug safety monitoring and management (aDSM) system aligned with WHO guidelines.
  • Monitored all clinically significant adverse events (AEs), with a focus on SAE detection by the PVU.
  • A panel of MDR-TB and PV experts reviewed unexpected and potentially drug-related SAEs to identify safety signals.

Main Results:

  • Between April 2015 and March 2019, the PVU processed 626 SAEs from 417 patients receiving BDQ.
  • Expert review identified safety signals, highlighting risk factors such as polypharmacy and off-label drug use.
  • The findings emphasized the importance of a patient-centered approach in managing complex TB treatment regimens.

Conclusions:

  • Organizing advanced pharmacovigilance within routine healthcare settings is achievable but resource-intensive.
  • Local and national programs can prioritize clinical management while reporting essential data like SAEs to aDSM systems.
  • The endTB PVU model provides valuable insights into managing safety for novel TB therapeutics.