Clinical outcomes with all-oral regimens in patients of drug-resistant tuberculosis: A prospective study in a tertiary hospital in North India.

The study aimed to analyze therapeutic outcomes with bedaquiline-based all-oral regimens for drug-resistant tuberculosis. A prospective observational study was conducted from August 2022 to March 2024 and patients of drug-resistant tuberculosis on all-oral regimens were enrolled. Among 100 patients enrolled (83 on longer-oral and 17 on shorter-oral), 73 patients from longer-oral regimens and 15 from the shorter-oral regimen were followed up at 6 months. Sixty-two (83.8%) patients of longer-oral, and 11 (64.7%) patients of the shorter oral regimen achieved microbiologic improvement in one sample. Clinical improvement occurred in the majority. Forty-five (60.8%) patients in the longer oral and six (35.3%) patients in the shorter-oral regimen required treatment modification, and the major reason was intolerability due to peripheral neuropathy. Skin pigmentation (43.2%), anemia (35.1%), and thrombocytopenia (25.7%) were other common adverse events in longer-oral regimen recipients. Optic neuritis occurred in two patients in the longer-oral regimen. Hepatitis and thrombocytopenia were common with regimens combining bedaquiline and delamanid. Linezolid dose was reduced in 44.6% and was replaced in 17.8% of the patients. Fluoroquinolone resistance emerged in 17.6% and 11.8% of patients in the longer-oral and shorter-oral regimens respectively. Interim microbiological outcomes with all-oral regimens of drug-resistant tuberculosis were favorable. Extended monitoring is needed to assess sustained treatment effect. Adverse events such as peripheral neuropathy are a major challenge and emphasize the need for a reduced dose of linezolid or newer regimens with better safety profiles.