Abstract:
BACKGROUND:Bedaquiline was recently introduced into World Health Organization (WHO)-recommended regimens for treatment of drug resistant tuberculosis. There is limited data on the long-term safety of bedaquiline. Because bedaquiline prolongs the QT interval, there are concerns regarding cardiovascular safety. The Western Cape Province in South Africa has an established pharmacovigilance programme: a targeted spontaneous reporting system which solicits reports of suspected adverse drug reactions (ADRs) in patients with HIV-1 and/or tuberculosis infection. Since 2015, bedaquiline has been included in the treatment regimens recommended for resistant tuberculosis in South Africa. We describe ADRs in patients on bedaquiline-containing tuberculosis treatment that were reported to the Western Cape Pharmacovigilance programme. METHODS:We reviewed reports of suspected ADRs and deaths received between March 2015 and June 2016 involving patients receiving bedaquiline-containing tuberculosis treatment. A multidisciplinary panel assessed causality, and categorised suspected ADRs using World Health Organisation-Uppsala Monitoring Centre system categories. "Confirmed ADRs" included all ADRs categorised as definite, probable or possible. Preventability was assessed using Schumock and Thornton criteria. Where a confirmed ADR occurred in a patient who died, the panel categorised the extent to which the ADR contributed to the patient's death as follows: major contributor, contributor or non-contributor. RESULTS:Thirty-five suspected ADRs were reported in 32 patients, including 13 deaths. There were 30 confirmed ADRs, of which 23 were classified as "possible" and seven as "probable". Bedaquiline was implicated in 22 confirmed ADRs in 22 patients. The most common confirmed ADR in patients receiving bedaquiline was QT prolongation (8 cases, 7 of which were severe). A fatal arrhythmia was suspected in 4 sudden deaths. These 4 patients were all taking bedaquiline together with other QT-prolonging drugs. There were 8 non-bedaquiline-associated ADRs, of which 7 contributed to deaths. CONCLUSIONS:Confirmed ADRs in patients receiving bedaquiline reflect the known safety profile of bedaquiline. Quantifying the incidence and clinical consequences of severe QT-prolongation in patients receiving bedaquiline-containing regimens is a research priority to inform recommendations for patient monitoring in treatment programmes for drug resistant tuberculosis. Pharmacovigilance systems within tuberculosis treatment programmes should be supported and encouraged, to provide ongoing monitoring of treatment-limiting drug toxicity.
journal_name
BMC Infect Disjournal_title
BMC infectious diseasesauthors
Jones J,Mudaly V,Voget J,Naledi T,Maartens G,Cohen Kdoi
10.1186/s12879-019-4197-7subject
Has Abstractpub_date
2019-06-20 00:00:00pages
544issue
1issn
1471-2334pii
10.1186/s12879-019-4197-7journal_volume
19pub_type
杂志文章abstract:BACKGROUND:Efficient control and management in the ongoing COVID-19 pandemic needs to carefully balance economical and realizable interventions. Simulation models can play a cardinal role in forecasting possible scenarios to sustain decision support. METHODS:We present a sophisticated extension of a classical SEIR mod...
journal_title:BMC infectious diseases
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journal_title:BMC infectious diseases
pub_type: 杂志文章
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/1471-2334-14-364
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pub_type: 杂志文章
doi:10.1186/s12879-020-05515-4
更新日期:2020-10-23 00:00:00
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journal_title:BMC infectious diseases
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doi:10.1186/s12879-017-2567-6
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journal_title:BMC infectious diseases
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pub_type: 杂志文章,评审
doi:10.1186/s12879-020-05480-y
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journal_title:BMC infectious diseases
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journal_title:BMC infectious diseases
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journal_title:BMC infectious diseases
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pub_type: 杂志文章,随机对照试验
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journal_title:BMC infectious diseases
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/s12879-017-2305-0
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/1471-2334-5-105
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/1471-2334-14-48
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/s12879-017-2216-0
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journal_title:BMC infectious diseases
pub_type: 杂志文章
doi:10.1186/s12879-016-2056-3
更新日期:2016-11-29 00:00:00
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journal_title:BMC infectious diseases
pub_type: 杂志文章
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