Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis

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...

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Vydané v:The European respiratory journal Ročník 49; číslo 3
Hlavní autori: Guglielmetti, Lorenzo, Jaspard, Marie, Le Dû, Damien, Lachâtre, Marie, Marigot-Outtandy, Dhiba, Bernard, Christine, Veziris, Nicolas, Robert, Jérôme, Yazdanpanah, Yazdan, Caumes, Eric, Fréchet-Jachym, Mathilde
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England 01.03.2017
Predmet:
Adult
Antitubercular Agents - administration & dosage
Antitubercular Agents - adverse effects
Diarylquinolines - administration & dosage
Diarylquinolines - adverse effects
Drug-Related Side Effects and Adverse Reactions - epidemiology
Female
France
Humans
Kaplan-Meier Estimate
Logistic Models
Male
Multivariate Analysis
Mycobacterium tuberculosis
Retrospective Studies
Sputum - microbiology
Treatment Outcome
Tuberculosis, Multidrug-Resistant - drug therapy
ISSN:1399-3003, 1399-3003
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Shrnutí: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.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1399-3003
1399-3003
DOI:10.1183/13993003.01799-2016