Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis
Open Access
- 22 December 2016
- journal article
- research article
- Published by European Respiratory Society (ERS) in European Respiratory Journal
- Vol. 49 (3), 1601799
- https://doi.org/10.1183/13993003.01799-2016
Abstract
Bedaquiline, a recently approved drug for the treatment of multidrug-resistant tuberculosis (MDR-TB), is recommended for a duration of 24 weeks. There are scarce data on patients treated with this drug outside clinical trials.All MDR-TB patients who started treatment from January 1, 2011 to December 31, 2013 and received ≥30 days of bedaquiline were included in a multicentre observational cohort.Among 45 MDR-TB patients, 53% harboured isolates resistant to both fluoroquinolones and second-line injectables, and 38% harboured isolates resistant to one of these drug classes. Median bedaquiline treatment duration was 361 days and 33 patients (73%) received prolonged (>190 days) bedaquiline treatment. Overall, 36 patients (80%) had favourable outcome, five were lost to follow-up, three died, and one failed and acquired bedaquiline resistance. No cases of recurrence were reported. Severe and serious adverse events were recorded in 60% and 18% of patients, respectively. Values of Fridericia-corrected QT interval (QTcF) >500 ms were recorded in 11% of patients, but neither arrhythmias nor symptomatic cardiac side-effects occurred. Bedaquiline was discontinued in three patients following QTcF prolongation. No significant differences in outcomes or adverse events rates were observed between patients receiving standard and prolonged bedaquiline treatment.Bedaquiline-containing regimens achieved favourable outcomes in a large proportion of patients. Prolonged bedaquiline treatment was overall well tolerated in this cohort.Keywords
This publication has 33 references indexed in Scilit:
- Preliminary Favorable Outcome for Medically and Surgically Managed Extensively Drug-Resistant Tuberculosis, France, 2009–2014Emerging Infectious Diseases, 2016
- Identification of patients who could benefit from bedaquiline or delamanid: a multisite MDR-TB cohort studyThe International Journal of Tuberculosis and Lung Disease, 2016
- Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosisEuropean Respiratory Journal, 2015
- Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysisThe International Journal of Tuberculosis and Lung Disease, 2015
- Compassionate Use of Bedaquiline for the Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis: Interim Analysis of a French CohortClinical Infectious Diseases, 2014
- Multidrug-Resistant Tuberculosis and Culture Conversion with BedaquilineThe New England Journal of Medicine, 2014
- Long-term outcomes of patients with extensively drug-resistant tuberculosis in South Africa: a cohort studyThe Lancet, 2014
- Resistance to fluoroquinolones and second-line injectable drugs: impact on multidrug-resistant TB outcomesEuropean Respiratory Journal, 2012
- Multidrug Resistant Pulmonary Tuberculosis Treatment Regimens and Patient Outcomes: An Individual Patient Data Meta-analysis of 9,153 PatientsPLoS Medicine, 2012
- Treatment outcomes among patients with multidrug-resistant tuberculosis: systematic review and meta-analysisThe Lancet Infectious Diseases, 2009