Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study - PubMed (original) (raw)

Multicenter Study

. 2017 May 21;49(5):1700387.

doi: 10.1183/13993003.00387-2017. Print 2017 May.

Keertan Dheda 3 2, Martin Enwerem 4 2, Rodolfo Romero Leyet 5 2, Lia D'Ambrosio 6 7 2, Rosella Centis 6 2, Giovanni Sotgiu 8 2, Simon Tiberi 9 10 2, Jan-Willem Alffenaar 11 2, Andrey Maryandyshev 12 2, Evgeny Belilovski 1 2, Shashank Ganatra 13 2, Alena Skrahina 14 2, Onno Akkerman 15 16, Alena Aleksa [ 17](#full-view-affiliation-17 "Dept of Phthisiology, Grodno State Medical University, GRCC "Phthisiology", Grodno, Belarus."), Rohit Amale 13, Janina Artsukevich [ 17](#full-view-affiliation-17 "Dept of Phthisiology, Grodno State Medical University, GRCC "Phthisiology", Grodno, Belarus."), Judith Bruchfeld 18, Jose A Caminero [ 19](#full-view-affiliation-19 "Pneumology Dept, Hospital General de Gran Canaria "Dr Negrin", Las Palmas de Gran Canaria, Spain.") 20, Isabel Carpena Martinez 21, Luigi Codecasa 22, Margareth Dalcolmo 23, Justin Denholm 24, Paul Douglas 25, Raquel Duarte 26, Aliasgar Esmail 27, Mohammed Fadul 27, Alexey Filippov 1, Lina Davies Forsman 18, Mina Gaga 28, Julia-Amaranta Garcia-Fuertes 29, José-María García-García 30, Gina Gualano [ 31](#full-view-affiliation-31 "Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases "L. Spallanzani", IRCCS, Rome, Italy."), Jerker Jonsson 32, Heinke Kunst 10, Jillian S Lau 33, Barbara Lazaro Mastrapa 34, Jorge Lazaro Teran Troya 34, Selene Manga 35, Katerina Manika 36, Pablo González Montaner 37, Jai Mullerpattan 13, Suzette Oelofse 27, Martina Ortelli 38, Domingo Juan Palmero 37, Fabrizio Palmieri [ 31](#full-view-affiliation-31 "Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases "L. Spallanzani", IRCCS, Rome, Italy."), Antonella Papalia 39, Apostolos Papavasileiou 40, Marie-Christine Payen 41, Emanuele Pontali 42, Carlos Robalo Cordeiro 43, Laura Saderi 8, Tsetan Dorji Sadutshang 44, Tatsiana Sanukevich [ 17](#full-view-affiliation-17 "Dept of Phthisiology, Grodno State Medical University, GRCC "Phthisiology", Grodno, Belarus."), Varvara Solodovnikova 14, Antonio Spanevello 45 46, Sonam Topgyal 44, Federica Toscanini 47, Adrian R Tramontana 48, Zarir Farokh Udwadia 13, Pietro Viggiani 39, Veronica White 49, Alimuddin Zumla 50, Giovanni Battista Migliori 51 2

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Multicenter Study

Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study

Sergey E Borisov et al. Eur Respir J. 2017.

Free article

Abstract

Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, observational study conducted in 25 centres and 15 countries in five continents.428 culture-confirmed MDR-TB cases were analysed (61.5% male; 22.1% HIV-positive, 45.6% XDR-TB). MDR-TB cases were admitted to hospital for a median (interquartile range (IQR)) 179 (92-280) days and exposed to bedaquiline for 168 (86-180) days. Treatment regimens included, among others, linezolid, moxifloxacin, clofazimine and carbapenems (82.0%, 58.4%, 52.6% and 15.3% of cases, respectively).Sputum smear and culture conversion rates in MDR-TB cases were 63.6% and 30.1%, respectively at 30 days, 81.1% and 56.7%, respectively at 60 days; 85.5% and 80.5%, respectively at 90 days and 88.7% and 91.2%, respectively at the end of treatment. The median (IQR) time to smear and culture conversion was 34 (30-60) days and 60 (33-90) days. Out of 247 culture-confirmed MDR-TB cases completing treatment, 71.3% achieved success (62.4% cured; 8.9% completed treatment), 13.4% died, 7.3% defaulted and 7.7% failed. Bedaquiline was interrupted due to adverse events in 5.8% of cases. A single case died, having electrocardiographic abnormalities that were probably non-bedaquiline related.Bedaquiline-containing regimens achieved high conversion and success rates under different nonexperimental conditions.

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