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.