Compassionate use of bedaquiline for the treatment of multidrug-resistant and extensively drug-resistant tuberculosis: interim analysis of a French cohort

Bedaquiline is a new antibiotic that was approved for the treatment of multidrug-resistant (MDR) tuberculosis. We aimed to evaluate the short-term microbiological efficacy and the tolerability profile of bedaquiline. We performed a retrospective cohort study among patients with MDR tuberculosis rece...

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Veröffentlicht in:Clinical infectious diseases Jg. 60; H. 2; S. 188
Hauptverfasser: Guglielmetti, Lorenzo, Le Dû, Damien, Jachym, Mathilde, Henry, Benoît, Martin, Diane, Caumes, Eric, Veziris, Nicolas, Métivier, Nathalie, Robert, Jérôme
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 15.01.2015
Schlagworte:
Adolescent
Adult
Aged
Antitubercular Agents - adverse effects
Antitubercular Agents - therapeutic use
Cohort Studies
Compassionate Use Trials
Diarylquinolines - adverse effects
Diarylquinolines - therapeutic use
Drug-Related Side Effects and Adverse Reactions
Extensively Drug-Resistant Tuberculosis - drug therapy
Female
France
Humans
Male
Middle Aged
Mycobacterium tuberculosis - isolation & purification
Retrospective Studies
Treatment Outcome
Young Adult
France
multidrug-resistant tuberculosis
TMC207
bedaquiline
extensively drug-resistant tuberculosis
safety
ISSN:1537-6591, 1537-6591
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Zusammenfassung:Bedaquiline is a new antibiotic that was approved for the treatment of multidrug-resistant (MDR) tuberculosis. We aimed to evaluate the short-term microbiological efficacy and the tolerability profile of bedaquiline. We performed a retrospective cohort study among patients with MDR tuberculosis receiving bedaquiline for compassionate use between January 2010 and July 2013 and evaluated at 6 months of bedaquiline treatment. A total of 35 patients with MDR tuberculosis were included in the study. Nineteen (54%) had extensively drug-resistant (XDR) tuberculosis, and 14 (40%) had isolates resistant to fluoroquinolones (Fqs) or second-line injectables. Bedaquiline was associated with a median of 4 (range, 2-5) other drugs, including linezolid in 33 (94%) cases. At 6 months of bedaquiline treatment, culture conversion was achieved in 28 of 29 (97%) cases with culture-positive pulmonary tuberculosis at bedaquiline initiation. Median time to culture conversion was 85 days (range, 8-235 days). Variables independently associated with culture conversion were treatment with a Fq (P = .01), absence of lung cavities (P < .001), and absence of hepatitis C virus infection (P = .001). A total of 7 patients (20%) experienced a ≥60-ms increase in QT interval, leading to bedaquiline discontinuation in 2 (6%) cases. Severe liver enzyme elevation occurred in 2 patients (6%). During the study period, 1 death (3%) occurred and was reported as unrelated to tuberculosis or antituberculosis treatment. The use of bedaquiline combined with other active drugs has the potential to achieve high culture conversion rates in complicated MDR and XDR tuberculosis cases, with a reassuring safety profile at 6 months of treatment.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1537-6591
1537-6591
DOI:10.1093/cid/ciu786