Effectiveness and safety of a shortened oral regimen for rifampicin- or multidrug-resistant TB.

BACKGROUND: Multidrug-resistant or rifampicin-resistant TB (MDR/RR-TB) poses significant challenges to patients, providers, and programmes. We evaluated a 9-month, 5-drug all-oral regimen implemented under operational conditions in Peru.

METHODS: Between February and September 2023, we enrolled 50 adults with confirmed pulmonary MDR/RR-TB in a prospective observational study conducted within Peru's National Tuberculosis Programme. The regimen consisted of bedaquiline, linezolid, levofloxacin, clofazimine, and delamanid, administered for 9 months and potentially extended to 12 months. We describe the frequency of clinically relevant adverse events of special interest, sputum culture conversion, end-of-treatment outcomes, and changes in dyspnoea and quality of life.

RESULTS: Of 50 participants, 24 (48%) were women, and median age was 28.5 years (interquartile range [IQR]: 23-59 years); 38 (76%) had cavitary disease, and 29 (58%) had bilateral disease. Adverse events were infrequent and manageable; only one case of linezolid-associated myelosuppression led to permanent drug discontinuation. Of 33 participants with positive sputum culture, 100% experienced culture conversion (median: 39 days, IQR: 31-61). Favourable end-of-treatment outcomes were observed in 40 (85.1%) (95% confidence interval: 72.3%-92.6%). Quality-of-life and dyspnoea scores improved significantly in those with treatment success.

CONCLUSION: This 9-month oral regimen was effective and safe and improved patient-reported outcomes. These results support broader adoption in national TB programmes across Latin America and beyond.