Setting up pharmacovigilance based on available endTB Project data for bedaquiline

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 delaman...

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Veröffentlicht in:The international journal of tuberculosis and lung disease 2020-10, Vol.24 (10), p.1087-1094
Hauptverfasser: Lachenal, N., Hewison, C., Mitnick, C., Lomtadze, N., Coutisson, S., Osso, E., Ahmed, S., Leblanc, G., 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, Perea, Kumsa, A., Reshid, A., Makaka, J., Abebe, S., Melikyan, N., Seung, K. J., Khan, U., Khan, P., Huerga, H., Rich, M., Varaine, F.
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Sprache:eng
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Zusammenfassung: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.
ISSN:1027-3719
1815-7920
DOI:10.5588/ijtld.20.0115