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

  • Guglielmetti L
  • Le Dû D
  • Jachym M
 et al. 
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Abstract

Background. 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. Methods. 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. Results. 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

Author-supplied keywords

  • France
  • QT interval
  • adult
  • aged
  • alanine aminotransferase
  • amikacin
  • aminosalicylic acid
  • amoxicillin plus clavulanic acid
  • article
  • aspartate aminotransferase
  • bacterium culture
  • bacterium isolate
  • bedaquiline
  • capreomycin
  • clinical article
  • clofazimine
  • cohort analysis
  • compassionate use
  • cycloserine
  • drug efficacy
  • drug safety
  • drug tolerability
  • drug withdrawal
  • ethambutol
  • ethionamide
  • extensively drug resistant tuberculosis
  • female
  • human
  • imipenem
  • kanamycin
  • linezolid
  • liver enzyme
  • lung cavity
  • lung tuberculosis
  • male
  • moxifloxacin
  • multidrug resistant tuberculosis
  • nonhuman
  • ofloxacin
  • priority journal
  • pyrazinamide
  • quinolone derivative
  • side effect
  • streptomycin
  • tmc 207

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Authors

  • L Guglielmetti

  • D Le Dû

  • M Jachym

  • B Henry

  • D Martin

  • E Caumes

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