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Volume 23, Number 10—October 2017

Off-Label Use of Bedaquiline in Children and Adolescents with Multidrug-Resistant Tuberculosis

Jay AcharComments to Author , Cathy Hewison, Ana P. Cavalheiro, Alena Skrahina, Junia Cajazeiro, Parpieva Nargiza, Krzysztof Herboczek, Assliddin S. Rajabov, Jennifer Hughes, Gabriella Ferlazzo, James A. Seddon, and Philipp du Cros
Author affiliations: Médecins Sans Frontières, London, UK (J. Achar, K. Herboczek, J.A. Seddon, P. du Cros); Médecins Sans Frontières, Paris, France (C. Hewison); Médecins Sans Frontières, Dushanbe, Tajikistan (A.P. Cavalheiro); Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus (A. Skrahina); Médecins Sans Frontières, Nukus, Karakalpakstan, Uzbekistan (J. Cajazeiro); Ministry of Health, Tashkent, Uzbekistan (P. Nargiza); State Enterprise of the Republican Center for the Protection of the Population from Tuberculosis, Dushanbe (A.S. Rajabov); Médecins Sans Frontières, Cape Town, South Africa (J. Hughes, G. Ferlazzo); Imperial College London, London (J.A. Seddon)

Main Article


Demographic, treatment, and outcome characteristics of a cohort of 27 children <18 years of age receiving bedaquiline for the treatment of MDR TB*

Characteristic No. (%)
Belarus 15 (56)
South Africa 3 (11)
Tajikistan 6 (22)
3 (11)
Age, y, median (range)
16 (10–17)
Female 15 (56)
12 (44)
Weight, kg, median (range) 50 (35–76)
Body mass index, kg/m2, median (IQR) 18.5 (17.2–19.6)
Cavities on baseline chest radiograph, n = 24 9 (38)
Baseline sputum smear positive 19 (70)
Baseline sputum culture positive
17 (63)
Baseline drug resistance pattern
MDR TB 0 (0)
Resistant to second-line injectable 3 (11)
Resistant to fluoroquinolone 6 (22)
18 (67)
Resistant drugs,† median (IQR), n = 24 5 (5–6)
Drugs in initial treatment regimen, median (IQR)
6 (6–7)
Drugs included in treatment regimen
Moxifloxacin 6 (22)
Clofazimine 26 (96)
Linezolid 26 (96)
4 (15)
Bedaquiline treatment duration if completed, d, median (IQR), n = 20 172 (168–178)
Sputum culture negative at February 24, 2017, n = 23 23 (100)
Sputum culture negative after 24 wks of bedaquiline, n = 22‡
22 (100)
Reported adverse effects
No grade 3 or 4 19 (70)
Grade 3 or 4, not caused by bedaquiline 3 (11)
Grade 3 or 4, caused by bedaquiline 5 (19)§

*Values are no. (%) patients except as indicated. IQR, interquartile range; MDR TB, multidrug-resistant tuberculosis; XDR TB, extensively drug-resistant tuberculosis; QTcF, QT interval corrected using the Fridericia formula.
†Resistance among the following drugs were considered: isoniazid, rifampin, ethambutol, pyrazinamide, kanamycin, any fluoroquinolone, amikacin, and capreomycin.
‡Twenty-seven children completed 24 weeks of bedaquiline, but data were available for 22.
§All 5 were children who experienced prolongation of QTcF.

Main Article

Page created: September 18, 2017
Page updated: September 18, 2017
Page reviewed: September 18, 2017
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.