Therapeutic outcomes of Bedaquiline containing oral regimens for Drug resistant tuberculosis

<bold>Introduction:</bold> Real-world evidence on oral regimens for drug-resistant tuberculosis (DR-TB) is scarce. <bold>Aims and objectives:</bold> To assess culture conversion at 6 months and adverse events (AEs) with oral regimens of DR-TB. <bold>Methods:</bold> A prospective observational study was conducted from August 2022 to January 2024 in a tertiary hospital in North India and patients of DR-TB eligible for all oral regimens were selected. Clinical improvement, culture conversion, and adverse events were recorded over 6 months of treatment. <bold>Results:</bold> Out of 100 patients of DR-TB enrolled, 83 received long oral regimens (Bdq+Lfx or Mfx+Lzd+Cfz+Cs in n=73, Bdq+Lzd+Cfz+Cs+Dlm in n=7, Bdq+Lzd+Cfz+Cs+E in n=3) and 17 received short oral regimen (4 months of Bdq+Hh+Eto+Cfz+Lfx+Z+E followed by 5 months of Cfz+Lfx+Z+E). Culture conversion was observed in 61 (73.5%) and 12 (70.6%) patients of long oral and short oral regimens respectively. 68 (81.9%) patients on long oral and 16 (94.1%) patients on short oral regimens showed significant clinical improvement. Adverse events causing modification in the treatment regimen occurred in 39 (46.9%) and 4 (23.5%) patients of long-oral and short-oral regimens respectively and peripheral neuropathy was the commonest AE. Clofazimine caused skin pigmentation in 23 patients, linezolid induced optic neuritis developed in 2 patients and QTc prolongation was observed in 7 patients. Additional resistance developed in 14 patients in the initial 3 months of treatment. <bold>Conclusion:</bold> Despite a favorable microbiologic response at six months with oral regimens for DR-TB, high intolerability due to adverse events and significant rates of additional resistance suggest the need for safer alternative therapies.