Short-course treatment outcomes and adverse events in adults and children-adolescents with MDR-TB in Niger

: SETTING Niger National Tuberculosis Programme. OBJECTIVE To describe the outcomes and adverse events (AEs) in a cohort of adults, children and adolescents with multidrug-resistant tuberculosis (MDR-TB) who were treated with the 'short-course regimen'. DESIGN The regimen comprised an intensive phase of 4-6 months with kanamycin, medium-high dose of isoniazid and prothionamide, and high doses of gatifloxacin, clofazimine, ethambutol and pyrazinamide throughout. Sixty-five patients were treated with a regimen of 12-14 months and 55 patients with a regimen of 9-11 months. RESULTS Of the 120 patients evaluated, 110 (92%) were adults (median age 31 years) and 10 (8%) were children or adolescents (median age 17 years). The treatment success rate was respectively 88% and 83% with the 9-month regimen, and 90% and 75% with the 12-month regimen in adults and children/adolescents. Initial resistance to ethambutol and prothionamide did not affect treatment success rates but resistance to fluoroquinolones did, although this was not statistically significant. Vomiting was the most frequently encountered AE, followed by ototoxicity and hepatotoxicity. AEs experienced were mild or moderate in severity in most patients, and did not lead to treatment interruption. CONCLUSION These results confirm the programmatic effectiveness and tolerability of the shorter regimen in second-line drug-naive patients. .