Publications & Reports

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

N Lachenal, C Hewison, C Mitnick, N Lomtadze, S Coutisson, E Osso, S Ahmed, G Leblanc, S Islam, H Atshemyan, P Nair, B Kholikulov, S Aiylchiev, K Zarli, S Adnan, A Krisnanda, S Padayachee, A Stambekova, Y Sahabutdinova, S de Guadalupe, Perea Moreno, A Kumsa, A Reshid, J Makaka, S Abebe, N Melikyan, K J Seung, U Khan, P Khan, H Huerga, M Rich, F Varaine
Medecins Sans Frontieres (MSF), Geneva, Switzerland.

Abstract

SETTING: 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).OBJECTIVE: To explain the endTB PVU process by describing the serious adverse events (SAEs) experienced by patients who received BDQ-containing regimens.DESIGN: The overall PV strategy was in line with the ‘advanced WHO active TB drug safety monitoring and management (aDSM) system. All adverse events (AEs) of clinical significance were followed up; the PVU focused on signal detection from SAEs.RESULTS and CONCLUSION: Between 1 April 2015 and 31 March 2019, the PVU received and assessed 626 SAEs experienced by 417 BDQ patients. A board of MDR-TB/PV experts reviewed unexpected and possibly drug-related SAEs to detect safety signals. The experts communicated on clusters of risks factors, notably polypharmacy and off-label drug use, encouraging a patient-centred approach of care. Organising advanced PV in routine care is possible but demanding. It is reasonable to expect local/national programmes to focus on clinical management, and to limit reporting to aDSM systems to key data, such as the SAEs.

Publication

  • Journal: The International Journal of Tuberculosis and Lung Disease
  • Published: 01/10/2020
  • Volume: 24
  • Issue: 10
  • Pagination: 1087-1094

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