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Safety of prolonged treatment with bedaquiline in programmatic conditions
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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108964/ https://www.ncbi.nlm.nih.gov/pubmed/35586446 http://dx.doi.org/10.1183/23120541.00685-2021 |
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author | Zhurkin, Dzmitriy Gurbanova, Elmira Campbell, Jonathon R. Menzies, Dick Setkina, Svetlana Hurevich, Hennadz Solodovnikova, Varvara Viatushka, Dzmitry Altraja, Alan Skrahina, Alena |
author_facet | Zhurkin, Dzmitriy Gurbanova, Elmira Campbell, Jonathon R. Menzies, Dick Setkina, Svetlana Hurevich, Hennadz Solodovnikova, Varvara Viatushka, Dzmitry Altraja, Alan Skrahina, Alena |
author_sort | Zhurkin, Dzmitriy |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9108964 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-91089642022-05-17 Safety of prolonged treatment with bedaquiline in programmatic conditions Zhurkin, Dzmitriy Gurbanova, Elmira Campbell, Jonathon R. Menzies, Dick Setkina, Svetlana Hurevich, Hennadz Solodovnikova, Varvara Viatushka, Dzmitry Altraja, Alan Skrahina, Alena ERJ Open Res Original Research Articles 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. European Respiratory Society 2022-05-16 /pmc/articles/PMC9108964/ /pubmed/35586446 http://dx.doi.org/10.1183/23120541.00685-2021 Text en Copyright ©The authors 2022 https://creativecommons.org/licenses/by-nc/4.0/This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org (mailto:permissions@ersnet.org) |
spellingShingle | Original Research Articles Zhurkin, Dzmitriy Gurbanova, Elmira Campbell, Jonathon R. Menzies, Dick Setkina, Svetlana Hurevich, Hennadz Solodovnikova, Varvara Viatushka, Dzmitry Altraja, Alan Skrahina, Alena Safety of prolonged treatment with bedaquiline in programmatic conditions |
title | Safety of prolonged treatment with bedaquiline in programmatic conditions |
title_full | Safety of prolonged treatment with bedaquiline in programmatic conditions |
title_fullStr | Safety of prolonged treatment with bedaquiline in programmatic conditions |
title_full_unstemmed | Safety of prolonged treatment with bedaquiline in programmatic conditions |
title_short | Safety of prolonged treatment with bedaquiline in programmatic conditions |
title_sort | safety of prolonged treatment with bedaquiline in programmatic conditions |
topic | Original Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108964/ https://www.ncbi.nlm.nih.gov/pubmed/35586446 http://dx.doi.org/10.1183/23120541.00685-2021 |
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