title: High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses.
abstract: METHODS
  Niger National Tuberculosis Programme. Regions supported by the Damien Foundation.
  
  
  OBJECTIVE
  To evaluate the effectiveness of a short-course standardised treatment regimen for patients with proven multidrug-resistant tuberculosis (MDR-TB) previously untreated with second-line drugs.
  
  
  METHODS
  Prospective study including all patients enrolled from 2008 to 2010. The 12-month standardised regimen comprised high doses of gatifloxacin, clofazimine, ethambutol and pyrazinamide throughout, supplemented by kanamycin, prothionamide and medium-high doses of isoniazid during the intensive phase of a minimum of 4 months. Patients were monitored using sputum smear and culture at start of treatment and every 2 months. Cured patients were followed up 6-monthly for 24 months.
  
  
  RESULTS
  Sixty-five patients with MDR-TB were included and analysed. One of 58 patients tested for human immunodeficiency virus (1.7%) infection was positive. Twenty-five patients (39.7%) were severely affected (body mass index ⩿16 kg/m(2)). Cure was achieved in 58 patients (89.2%, 95%CI 81.7-96.7), 6 died and 1 defaulted. All 49 patients assessed at the 24-month follow-up after cure remained smear- and culture-negative. The main adverse events were vomiting (26.2%) and hearing impairment (20%), but no treatment had to be stopped.
  
  
  CONCLUSIONS
  Standardised 12-month treatment for MDR-TB was highly effective and well tolerated in patients not previously exposed to second-line drugs in Niger.
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: A
authors.initials: A
authors.lastname: Piubello
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: S Hassane
authors.initials: SH
authors.lastname: Harouna
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: M B
authors.initials: MB
authors.lastname: Souleymane
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: I
authors.initials: I
authors.lastname: Boukary
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: S
authors.initials: S
authors.lastname: Morou
authors.affiliation: Damien Foundation, Niamey, Niger.
authors.forename: M
authors.initials: M
authors.lastname: Daouda
authors.affiliation: National Hospital of Niamey, Niger.
authors.forename: Y
authors.initials: Y
authors.lastname: Hanki
authors.affiliation: International Union Against Tuberculosis and Lung Disease, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Van Deun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001835:Body Weight; D002991:Clofazimine / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D024901:Drug Resistance, Multiple, Bacterial; D004977:Ethambutol / Q000627:therapeutic use; D005260:Female; D024841:Fluoroquinolones / Q000627:therapeutic use; D005500:Follow-Up Studies; D000077734:Gatifloxacin; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007612:Kanamycin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009548:Niger / Q000453:epidemiology; D011446:Prospective Studies; D011718:Pyrazinamide / Q000627:therapeutic use; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy* / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D024841:Fluoroquinolones; D011718:Pyrazinamide; D007612:Kanamycin; D004977:Ethambutol; D002991:Clofazimine; D000077734:Gatifloxacin