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    Jan 15, 2021
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    Adverse events among people on delamanid for rifampicin-resistant tuberculosis in a high HIV prevalence setting

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    Hughes et al 2019 Adverse events ...
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    Authors
    Hughes, J
    Reuter, A
    Chabalala, B
    Isaakidis, P
    Cox, H
    Mohr, E
    Issue Date
    2019-09-01
    Submitted date
    2019-11-08
    
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    Journal
    International Journal of Tuberculosis and Lung Disease
    Abstract
    SETTING: Patients with rifampicin-resistant tuberculosis (RR-TB) in the township of Khayelitsha, South Africa, were offered delamanid (DLM) within a decentralised RR-TB treatment programme. OBJECTIVE: To describe adverse events (AEs) among HIV-positive and negative people receiving DLM for RR-TB in a programmatic setting. DESIGN: Patients were followed up monthly for blood, electrocardiography and clinical monitoring and AEs were assessed for severity grade, seriousness and relationship to DLM. RESULTS: Fifty-eight patients (55% male; median age 35 years, interquartile range [IQR] 28–42) started DLM; 46 (79%) were HIV-positive, median CD4 count 173 cells/mm3 (IQR 70–294). Fifty (86%) patients experienced ≥1 new or worsening AE after starting DLM, most commonly vomiting, QTcB >450 ms and/or myalgia. Serious and/or severe AEs were experienced by 22 (38%) patients; three HIV-positive patients died (not related to DLM). HIV status was not significantly associated with number (P = 0.089) or severity/seriousness (P = 0.11) of AEs during exposure to DLM. Two (3%) patients had DLM withdrawn due to AEs. CONCLUSION: AEs during RR-TB treatment, both before and during DLM exposure, were common, with relatively few serious/severe AEs considered related to DLM and no significant association with HIV status. Clinical and electrocardiography monitoring should be prioritised in the first two months after starting DLM.
    Publisher
    International Union Against Tuberculosis and Lung Disease
    URI
    http://hdl.handle.net/10144/619505
    Language
    en
    Collections
    TB

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