High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses

Int J Tuberc Lung Dis. 2014 Oct;18(10):1188-94. doi: 10.5588/ijtld.13.0075.

Abstract

Setting: 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.

Conclusion: Standardised 12-month treatment for MDR-TB was highly effective and well tolerated in patients not previously exposed to second-line drugs in Niger.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Body Mass Index
  • Body Weight
  • Clofazimine / therapeutic use
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Drug Resistance, Multiple, Bacterial
  • Ethambutol / therapeutic use
  • Female
  • Fluoroquinolones / therapeutic use
  • Follow-Up Studies
  • Gatifloxacin
  • HIV Infections / drug therapy
  • Humans
  • Kanamycin / therapeutic use
  • Male
  • Middle Aged
  • Niger / epidemiology
  • Prospective Studies
  • Pyrazinamide / therapeutic use
  • Treatment Outcome
  • Tuberculosis, Multidrug-Resistant / drug therapy*
  • Tuberculosis, Multidrug-Resistant / epidemiology*
  • Young Adult

Substances

  • Drug Combinations
  • Fluoroquinolones
  • Pyrazinamide
  • Kanamycin
  • Ethambutol
  • Clofazimine
  • Gatifloxacin