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Journal Article > Research

Setting up pharmacovigilance based on available endTB project data for bedaquiline

Lachenal N, Hewison CCH, Mitnick CD, Lomtadze N, Coutisson S, Osso E, Ahmed SM, Leblanc GJ, Islam S, Atshemyan H, Nair P, Kholikulov B, Aiylchiev S, Zarli K, Adnan S, Krisnanda A, Padayachee S, Stambekova A, Sahabutdinova Y, de Guadalupe S, Moreno P, Kumsa A, Reshid A, Makaka J, Abebe S, Melikyan N, Seung KJ, Khan UT, Khan PY, Huerga H, Rich ML, Varaine FFV
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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.
Subject Area
tuberculosis
Collections
The endTB project
DOI
10.5588/ijtld.20.0115
Published Date
01-Oct-2020
PubMed ID
33126944
Languages
English
Journal
International Journal of Tuberculosis and Lung Disease
Volume / Issue / Pages
Volume 24, Issue 10, Pages 1087-1094
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