PMID- 33126944
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Linking)
VI  - 24
IP  - 10
DP  - 2020 Oct 1
TI  - Setting up pharmacovigilance based on available endTB Project data for 
      bedaquiline.
PG  - 1087-1094
LID - 10.5588/ijtld.20.0115 [doi]
AB  - 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.
FAU - Lachenal, N
AU  - Lachenal N
AD  - Medecins Sans Frontieres (MSF), Geneva, Switzerland.
FAU - Hewison, C
AU  - Hewison C
AD  - MSF, Paris, France.
FAU - Mitnick, C
AU  - Mitnick C
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      MA, Partners In Health (PIH), Boston, MA, USA.
FAU - Lomtadze, N
AU  - Lomtadze N
AD  - Ministry of Health, Surveillance and Strategic Planning Department, Tbilisi, 
      Georgia.
FAU - Coutisson, S
AU  - Coutisson S
AD  - Medecins Sans Frontieres (MSF), Geneva, Switzerland.
FAU - Osso, E
AU  - Osso E
AD  - Partners In Health (PIH), Boston, MA, USA, Harvard Medical School, Boston, MA, 
      USA.
FAU - Ahmed, S
AU  - Ahmed S
AD  - Interactive Research and Development (IRD), Karachi, Pakistan.
FAU - Leblanc, G
AU  - Leblanc G
AD  - Zamni Lasante, Cange, Haiti.
FAU - Islam, S
AU  - Islam S
AD  - IRD, Dhaka, Bangladesh.
FAU - Atshemyan, H
AU  - Atshemyan H
AD  - MSF, Yerevan, Armenia.
FAU - Nair, P
AU  - Nair P
AD  - MSF, Minsk, Belarus.
FAU - Kholikulov, B
AU  - Kholikulov B
AD  - MSF, Minsk, Belarus.
FAU - Aiylchiev, S
AU  - Aiylchiev S
AD  - MSF, Osh, Kyrgyzstan.
FAU - Zarli, K
AU  - Zarli K
AD  - MSF, Yangon, Myanmar.
FAU - Adnan, S
AU  - Adnan S
AD  - Indus Health Network, Karachi, Pakistan.
FAU - Krisnanda, A
AU  - Krisnanda A
AD  - IRD, Jakarta, Indonesia.
FAU - Padayachee, S
AU  - Padayachee S
AD  - IRD, Durban, South Africa.
FAU - Stambekova, A
AU  - Stambekova A
AD  - PIH, Almaty, Kazakhstan.
FAU - Sahabutdinova, Y
AU  - Sahabutdinova Y
AD  - PIH, Almaty, Kazakhstan.
FAU - de Guadalupe, S
AU  - de Guadalupe S
FAU - Moreno, Perea
AU  - Moreno P
AD  - Socios En Salud, Lima, Peru.
FAU - Kumsa, A
AU  - Kumsa A
AD  - PIH, Addis Ababa, Ethiopia.
FAU - Reshid, A
AU  - Reshid A
AD  - PIH, Addis Ababa, Ethiopia.
FAU - Makaka, J
AU  - Makaka J
AD  - PIH, Maseru, Lesotho.
FAU - Abebe, S
AU  - Abebe S
AD  - PIH, Maseru, Lesotho.
FAU - Melikyan, N
AU  - Melikyan N
AD  - MSF, Paris, France.
FAU - Seung, K J
AU  - Seung KJ
AD  - Partners In Health (PIH), Boston, MA, USA, Division of Global Health Equity, 
      Brigham and Women s Hospital, Boston, MA, USA.
FAU - Khan, U
AU  - Khan U
AD  - IRD, Singapore, Singapore.
FAU - Khan, P
AU  - Khan P
AD  - IRD, Singapore, Singapore.
FAU - Huerga, H
AU  - Huerga H
AD  - MSF, Paris, France.
FAU - Rich, M
AU  - Rich M
AD  - Partners In Health (PIH), Boston, MA, USA, Division of Global Health Equity, 
      Brigham and Women s Hospital, Boston, MA, USA.
FAU - Varaine, F
AU  - Varaine F
AD  - MSF, Paris, France.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
RN  - 0 (Diarylquinolines)
RN  - 78846I289Y (bedaquiline)
SB  - IM
MH  - Antitubercular Agents/adverse effects
MH  - Diarylquinolines/adverse effects
MH  - Humans
MH  - Off-Label Use
MH  - *Pharmacovigilance
MH  - *Tuberculosis, Multidrug-Resistant/drug therapy
EDAT- 2020/11/01 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/10/31 05:23
PHST- 2020/10/31 05:23 [entrez]
PHST- 2020/11/01 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
AID - 10.5588/ijtld.20.0115 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1087-1094. doi: 10.5588/ijtld.20.0115.