PMID- 35586446
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2312-0541 (Print)
IS  - 2312-0541 (Electronic)
IS  - 2312-0541 (Linking)
VI  - 8
IP  - 2
DP  - 2022 Apr
TI  - Safety of prolonged treatment with bedaquiline in programmatic conditions.
LID - 00685-2021 [pii]
LID - 10.1183/23120541.00685-2021 [doi]
AB  - Bedaquiline is now considered a first-line medicine for treatment of 
      rifampicin-resistant tuberculosis (RR-TB). We evaluated the safety of treatment 
      with bedaquiline for longer than 190 days in individuals with RR-TB under 
      programmatic conditions. In a prospective cohort study enrolling pulmonary RR-TB 
      patients, we initiated bedaquiline-based treatment at a tertiary hospital in 
      Belarus. We defined standard bedaquiline use as <190 days and prolonged as 
      >/=190 days. We recorded adverse events (AEs) and classified their seriousness and 
      relation to bedaquiline. Our primary outcome in regression analyses was the 
      incidence of serious AEs occurring within 5 months of bedaquiline cessation. We 
      used generalised estimating equations to estimate the adjusted incidence rate 
      ratio (aIRR) of serious AEs between the prolonged and standard bedaquiline 
      groups. We enrolled 113 patients, 83 (73%) of whom received standard and 30 (27%) 
      received prolonged treatment. A total of 2030 AEs occurred during treatment. Of 
      these, 63 (3.1%) were serious AEs occurring within 5 months of bedaquiline 
      cessation; QTcF prolongation was the most common bedaquiline-related serious AE. 
      The incidence of serious AEs per 100 person-months was 5.4 (3.9 to 7.2) in the 
      standard group and 4.4 (2.6 to 7.0) in the prolonged group. In adjusted analyses, 
      serious AEs were no different (aIRR: 0.82, 95% CI 0.42-1.61) in the prolonged 
      group. One patient in the standard bedaquiline group died of acute 
      cardiopulmonary failure deemed possibly related to bedaquiline. Prolonged use of 
      bedaquiline under programmatic conditions appears safe. Clinicians should 
      carefully monitor QTcF interval since its prolongation was commonly observed.
CI  - Copyright (c)The authors 2022.
FAU - Zhurkin, Dzmitriy
AU  - Zhurkin D
AD  - Republican Scientific and Practical Center of Pulmonology and Tuberculosis, 
      Minsk, Belarus.
FAU - Gurbanova, Elmira
AU  - Gurbanova E
AD  - Lung Clinic, University of Tartu, Tartu, Estonia.
AD  - WHO Collaborating Centre on TB in Prisons, Baku, Azerbaijan.
FAU - Campbell, Jonathon R
AU  - Campbell JR
AUID- ORCID: 0000-0003-2341-2166
AD  - Dept of Epidemiology, Biostatistics, and Occupational Health, McGill University, 
      Montreal, Canada.
AD  - McGill International TB Centre, Montreal, Canada.
FAU - Menzies, Dick
AU  - Menzies D
AD  - Dept of Epidemiology, Biostatistics, and Occupational Health, McGill University, 
      Montreal, Canada.
AD  - McGill International TB Centre, Montreal, Canada.
AD  - Montreal Chest Institute, Montreal, Canada.
FAU - Setkina, Svetlana
AU  - Setkina S
AD  - Center for Examinations and Tests in Health Service, Minsk, Belarus.
FAU - Hurevich, Hennadz
AU  - Hurevich H
AD  - Republican Scientific and Practical Center of Pulmonology and Tuberculosis, 
      Minsk, Belarus.
FAU - Solodovnikova, Varvara
AU  - Solodovnikova V
AD  - Republican Scientific and Practical Center of Pulmonology and Tuberculosis, 
      Minsk, Belarus.
FAU - Viatushka, Dzmitry
AU  - Viatushka D
AD  - Republican Scientific and Practical Center of Pulmonology and Tuberculosis, 
      Minsk, Belarus.
FAU - Altraja, Alan
AU  - Altraja A
AUID- ORCID: 0000-0001-7798-9871
AD  - Lung Clinic, University of Tartu, Tartu, Estonia.
AD  - WHO Collaborating Centre on TB in Prisons, Baku, Azerbaijan.
FAU - Skrahina, Alena
AU  - Skrahina A
AD  - Republican Scientific and Practical Center of Pulmonology and Tuberculosis, 
      Minsk, Belarus.
LA  - eng
PT  - Journal Article
DEP - 20220516
PL  - England
TA  - ERJ Open Res
JT  - ERJ open research
JID - 101671641
PMC - PMC9108964
COIS- Conflict of interest: All authors declare no conflicts of interest.
EDAT- 2022/05/20 06:00
MHDA- 2022/05/20 06:01
PMCR- 2022/05/16
CRDT- 2022/05/19 02:25
PHST- 2021/12/05 00:00 [received]
PHST- 2022/03/17 00:00 [accepted]
PHST- 2022/05/19 02:25 [entrez]
PHST- 2022/05/20 06:00 [pubmed]
PHST- 2022/05/20 06:01 [medline]
PHST- 2022/05/16 00:00 [pmc-release]
AID - 00685-2021 [pii]
AID - 10.1183/23120541.00685-2021 [doi]
PST - epublish
SO  - ERJ Open Res. 2022 May 16;8(2):00685-2021. doi: 10.1183/23120541.00685-2021. 
      eCollection 2022 Apr.