Post-Bedaquiline era in Brazil: impact on adverse events and treatment outcomes.

Rifampicin/Multidrug Resistant Tuberculosis (RR/MR-TB) is a major challenge in controlling TB. The incorporation of Bedaquiline (Bed) by the World Health Organization allowed a completely oral regimen. Brazil’s Ministry of Health implemented the new drug in 2021. We aimed to evaluate regimens before, which included injectable drugs, and after Bed and evaluate occurrence of adverse events (AE) and TB treatment outcomes (TO). SPSS®V.21 was used to perform multivariate logistic regression analysis and calculate adjusted odds ratio (aOR) with their respective 95% confidence interval (95%CI) for AE and favorable/unfavorable TO under routine conditions at Federal University of Rio de Janeiro, which accounts with one of the largest drug resistant TB (DRTB) centers in Brazil. Between 2016-2023, 297/463 patients were included for analysis. The majority were men (63.3%) with a median age of 35 year (Inter Quartile Range 26-49). 33/211 of HIV known status were positive. According to TB treatment, 62.3% were Before Bed group and 37.7% After Bed group. 56.6% presented favorable TB TO. DRTB re-treatment, illicit drug use, unfavorable outcomes and After Bed (aOR 0.18, 95%CI 0.10-0.35, p<0.0001) were considered protective for AE occurrence, while alcohol abuse was a risk factor for it. Higher years of schooling, primary resistance, no history DRTB re-treatment, smoking, and use of a regimen after Bed (aOR 2.26, 95%Cl 1.26-4.07, p=0.006) were associated with favorable outcomes. In our sample, Bed regimens were protective against AE and positively associated with favorable outcomes. Despite any DRTB treatment regimens, social aspects must be taken into consideration to ensure safer follow up and better outcomes.