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Volume 23, Number 10—October 2017

Dispatch

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

Table

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. (%)
Country
Belarus 15 (56)
South Africa 3 (11)
Tajikistan 6 (22)
Uzbekistan
3 (11)
Age, y, median (range)
16 (10–17)
Sex
Female 15 (56)
Male
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)
Pre–XDR TB
Resistant to second-line injectable 3 (11)
Resistant to fluoroquinolone 6 (22)
XDR TB
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)
Imipenem
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.

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