TY - JOUR
T1 - Effectiveness and safety of bedaquilinecontaining regimens in the treatment of MDR- and XDR-TB
T2 - A multicentre study
AU - Borisov, Sergey E.
AU - Dheda, Keertan
AU - Enwerem, Martin
AU - Leyet, Rodolfo Romero
AU - D'Ambrosio, Lia
AU - Centis, Rosella
AU - Sotgiu, Giovanni
AU - Tiberi, Simon
AU - Alffenaar, Jan Willem
AU - Maryandyshev, Andrey
AU - Belilovski, Evgeny
AU - Ganatra, Shashank
AU - Skrahina, Alena
AU - Akkerman, Onno
AU - Aleksa, Alena
AU - Amale, Rohit
AU - Artsukevich, Janina
AU - Bruchfeld, Judith
AU - Caminero, Jose A.
AU - Martinez, Isabel Carpena
AU - Codecasa, Luigi
AU - Dalcolmo, Margareth
AU - Denholm, Justin
AU - Douglas, Paul
AU - Duarte, Raquel
AU - Esmail, Aliasgar
AU - Fadul, Mohammed
AU - Filippov, Alexey
AU - Forsman, Lina Davies
AU - Gaga, Mina
AU - Garcia-Fuertes, Julia Amaranta
AU - García-García, José María
AU - Gualano, Gina
AU - Jonsson, Jerker
AU - Kunst, Heinke
AU - Lau, Jillian S.
AU - Mastrapa, Barbara Lazaro
AU - Troya, Jorge Lazaro Teran
AU - Manga, Selene
AU - Manika, Katerina
AU - Montaner, Pablo González
AU - Mullerpattan, Jai
AU - Oelofse, Suzette
AU - Ortelli, Martina
AU - Palmero, Domingo Juan
AU - Palmieri, Fabrizio
AU - Papalia, Antonella
AU - Papavasileiou, Apostolos
AU - Payen, Marie Christine
AU - Pontali, Emanuele
AU - Cordeiro, Carlos Robalo
AU - Saderi, Laura
AU - Sadutshang, Tsetan Dorji
AU - Sanukevich, Tatsiana
AU - Solodovnikova, Varvara
AU - Spanevello, Antonio
AU - Topgyal, Sonam
AU - Toscanini, Federica
AU - Tramontana, Adrian R.
AU - Udwadia, Zarir Farokh
AU - Viggiani, Pietro
AU - White, Veronica
AU - Zumla, Alimuddin
AU - Migliori, Giovanni Battista
N1 - Publisher Copyright:
Copyright © ERS 2017.
PY - 2017/5
Y1 - 2017/5
N2 - 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% XDRTB). 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.
AB - 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% XDRTB). 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.
UR - http://www.scopus.com/inward/record.url?scp=85026222831&partnerID=8YFLogxK
U2 - 10.1183/13993003.00387-2017
DO - 10.1183/13993003.00387-2017
M3 - Article
C2 - 28529205
AN - SCOPUS:85026222831
SN - 0903-1936
VL - 49
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 5
M1 - 1700387
ER -