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dc.contributor.authorLachenal, N
dc.contributor.authorHewison, C
dc.contributor.authorMitnick, C
dc.contributor.authorLomtadze, N
dc.contributor.authorCoutisson, S
dc.contributor.authorOsso, E
dc.contributor.authorAhmed, S
dc.contributor.authorLeblanc, G
dc.contributor.authorIslam, S
dc.contributor.authorAtshemyan, H
dc.contributor.authorNair, P
dc.contributor.authorKholikulov, B
dc.contributor.authorAiylchiev, S
dc.contributor.authorZarli, K
dc.contributor.authorAdnan, S
dc.contributor.authorKrisnanda, A
dc.contributor.authorPadayachee, S
dc.contributor.authorStambekova, A
dc.contributor.authorSahabutdinova, Y
dc.contributor.authorde Guadalupe, S
dc.contributor.authorMoreno, P
dc.contributor.authorKumsa, A
dc.contributor.authorReshid, A
dc.contributor.authorMakaka, J
dc.contributor.authorAbebe, S
dc.contributor.authorMelikyan, N
dc.contributor.authorSeung, KJ
dc.contributor.authorKhan, U
dc.contributor.authorKhan, P
dc.contributor.authorHuerga, H
dc.contributor.authorRich, M
dc.contributor.authorVaraine, F
dc.date.accessioned2020-12-05T17:04:50Z
dc.date.available2020-12-05T17:04:50Z
dc.date.issued2020-10-01
dc.date.submitted2020-12-03
dc.identifier.urihttp://hdl.handle.net/10144/619801
dc.description.abstractSETTING: 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.en_US
dc.language.isoenen_US
dc.publisherInternational Union Against Tuberculosis and Lung Diseaseen_US
dc.rightsWith thanks to the International Union Against Tuberculosis and Lung Disease.en_US
dc.titleSetting up pharmacovigilance based on available endTB Project data for bedaquilineen_US
dc.identifier.journalThe International Journal of Tuberculosis and Lung Diseaseen_US
refterms.dateFOA2020-12-05T17:04:50Z


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