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Volume 23, Number 10—October 2017


Bedaquiline and Delamanid Combination Treatment of 5 Patients with Pulmonary Extensively Drug-Resistant Tuberculosis

Andrey Maryandyshev1, Emanuele Pontali1, Simon Tiberi1, Onno Akkerman1, Shashank Ganatra1, Tsetan Dorji Sadutshang1, Jan-Willem Alffenaar1, Rohit Amale, Jai Mullerpattan, Sonam Topgyal, Zarir Farokh Udwadia, Rosella Centis1, Lia D’Ambrosio1, Giovanni Sotgiu1, and Giovanni Battista MiglioriComments to Author 
Author affiliations: Northern State Medical University, Arkhangelsk, Russia (A. Maryandyshev); Galliera Hospital, Genoa, Italy (E. Pontali); Royal London Hospital of Barts Health National Health Service Trust, London, UK (S. Tiberi); Queen Mary University of London, London (S. Tiberi); University of Groningen, Haren, the Netherlands (O. Akkerman, J.-W. Alffenaar); P.D. Hinduja National Hospital and Medical Research Centre, Mumbai, India (S. Ganatra, R. Amale, J. Mullerpattan, Z.F. Udwadia); Delek Hospital, Dharamshala, India (T.D. Sadutshang, S. Topgyal); Maugeri Care and Research Institute, Tradate, Italy (R. Centis, L. D’Ambrosio, G.B. Migliori); Public Health Consulting Group, Lugano, Switzerland (L. D’Ambrosio); University of Sassari, Sassari, Italy (G. Sotgiu)

Main Article

Table 2

Summary of patients treated with bedaquiline and delamanid, including data on the anti-TB regimen administered, bacteriological conversion, treatment outcomes, and QT interval monitoring*

Pt no. Last TB drug regimen administered Sputum smear/culture conversion, d (treatment outcome) Dlm/Bdq exposure, d QT before treatment, ms QT average, ms (±SD) QT max, ms (wk)
1 Cm, Mfx, Eto, Cs, PAS, Cfz, Mpm, Lfx, Amx/Clv, Lzd, Bdq, Dlm NA/NA (failure; 4 mo after completing Bdq + Dlm treatment course, patient died because of respiratory insufficiency) 168/168 410 426 (±17.6) 450 (9)
2 Hd H, Cfz, Cs, E, Lzd, Dlm, Bdq; as of April 28, 2017, receving: Hd H, Cs, Cfz, cotrimoxazole 60/60 (continued treatment) 168/168 400 406 (±33.6) 462 (24)
3 Cm, Mfx, Bdq, Dlm, Lzd, Imp, Amx/Clv 435/104 (cured) 180/180 340 363 (±25.8) 400 (35 and 51)
4 Bdq, Dlm, Lzd, Cfz 30/30 (continued treatment) 155/155 394 462 (±39.8) 509 (5 and 9)
5 Dlm, Bdq, Cfz, Trd, Mpm, Amx/Clv 18/28 (continued treatment) 427/427 449 504 (±6.3) 520 (16)†

*Amk, amikacin; Amx/Clv, amoxicillin/clavulanate; Bdq, bedaquiline; Cfz, clofazimine; Cm, capreomycin; Cs, cycloserine; Dlm, delamanid; E, ethambutol; Eto, ethionamide; H, isoniazid; Hd, high dose; Imp, imipenem; Lfx, levofloxacin; Lzd, linezolid; max, maximum; Mfx, moxifloxacin; Mpm, meropenem; NA, not achieved; PAS, para-aminosalicylic acid; Pto, prothionamide; Pt, patient; QT, measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; SD, standard deviation; TB, tuberculosis; Trd, terizidone.
†At different time points, intermittent episodes of asymptomatic QTc prolongation occurred.

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1These authors contributed equally to this article.