Abstract

Background: Ototoxicity remains one of the major adverse events during multidrug-resistant tuberculosis (MDR-TB) treatment. It is related to the use of aminoglycosides. Bedaquiline offers an opportunity to promote a shorter regimen without aminoglycosides. Methods: This is a retrospective study. We reviewed all the MDR-TB patients with hearing losses for which a 9 month regimen has been applied in 2018 in Kinshasa, DR Congo. Kamamycin and Moxifloxacin had been replaced by Bedaquiline and levofloxacin. Treatment was given ambulatory under dot’s unless the emergencies. Monthly follow-up included clinical and bacteriological features, renal and liver functions, QT Interval. Results: From 184 patients selected for 9 months shorter regimen according to WHO guidelines, 39 had hearing loss (21.2%) and were selected for the study. Mean-age was 35.7 years (Range 18-65), 21 male (54%), 8 (21%) HIV positive, 25 (64%) were under weighted; 26 patients (66.7%) had 50% or less, the 2 lungs fields affected on chest X-ray, and 20 patients (51.2%) with one or more cavities. Sputum smear conversion was respectively 82% and 97.2% at 2 and 4 months. Culture conversion was 86% and 97.2% for the same time. Cultures and Sputum smear remained negative until 9th month for 97.2% patients. Adverse events have been reported by 23 patients (58.9%), but they were severe and very severe only in 2 cases (5.1%). No QT interval over 500 millisecond (ms) noted. Treatment outcomes were: 32 patients cured (82.05%), 3 with treatment completed (7.7%), 3 (7.7%) Died, 1 (2.5%) failure. The follow-up of 6 months after treatment completion did not reveal relapse case. Conclusion: The 9 months shorter regimen with bedaquiline showed a good safety and efficacy with a treatment success of 89.75%. This study shows also that the use of bedaquiline is possible even in low-income environment.

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