Original Research

Adverse effects of bedaquiline in patients with extensively drug-resistant tuberculosis

Razia Gaida, Ilse Truter, Charles A. Peters
Southern African Journal of Infectious Diseases | Vol 35, No 1 | a23 | DOI: https://doi.org/10.4102/sajid.v35i1.23 | © 2020 Razia Gaida, Ilse Truter, Charles A. Peters | This work is licensed under CC Attribution 4.0
Submitted: 10 May 2019 | Published: 14 October 2020

About the author(s)

Razia Gaida, Drug Utilization Research Unit (DURU), Department of Pharmacy, Faculty of Health Sciences, Nelson Mandela University, Port Elizabeth, South Africa; and Social Aspects of Public Health Unit, Human Sciences Research Council, Port Elizabeth, South Africa
Ilse Truter, Drug Utilization Research Unit (DURU), Department of Pharmacy, Faculty of Health Sciences, Nelson Mandela University, Port Elizabeth, South Africa
Charles A. Peters, Jose Pearson TB Hospital, Eastern Cape Department of Health, Port Elizabeth, South Africa


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Abstract

Background: The World Health Organisation (WHO) guidelines recommend that, because of the resistance patterns of extensively drug-resistant (XDR) tuberculosis (TB) and its unique mechanism of action, bedaquiline be included in the regimen. Although the results of clinical trials have shown bedaquiline to be beneficial, it also carries the risk of adverse effects, some potentially life-threatening. The aim of the study was to determine the incidence of adverse effects caused by bedaquiline in patients diagnosed with XDR-TB. The subsequent management of these adverse effects was also analysed.

Methods: The medical records of patients aged 18 years or older living with XDR-TB who were prescribed bedaquiline in combination with a background regimen at a public-sector drug-resistant TB hospital in the Eastern Cape were reviewed.

Results: Thirty records were reviewed in September 2016. Female patients constituted 66.67% (n = 20) of the sample. Nearly half (46.67%; n = 14) of the patients were living with human immunodeficiency virus, and six (42.86%) of them were female. Adverse effects were recorded for 26 patients (86.67%) including corrected QT prolongation (40%; n = 12), skin rash (33.33%; n = 10) and hyperlactataemia (33.33%; n = 10) as the most common. There were no treatment discontinuations or deaths. The management of adverse effects varied from omitting doses of bedaquiline to pharmacological intervention.

Conclusion: All patients completed bedaquiline treatment, indicating that the adverse effects did not require discontinuation of the drug. However, when pharmacological intervention is required for the management of adverse effects, care should be taken to ensure that there is minimal interaction with other TB drugs and a low risk of further adverse effects.


Keywords

bedaquiline; adverse effects; extensively drug resistant tuberculosis (XDR-TB); Eastern Cape; World Health Organisation.

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