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

Objective: The main aim of this study is to provide therapeutic outcomes with bedaquiline-based all-oral regimens of drug-resistant tuberculosis (DR-TB). Methods : A prospective observational study was conducted from August 2022 to March 2024 and patients of DR-TB on all-oral regimens were enrolled. Results: Seventy-three patients from long-oral (LO) regimens and 15 from the short-oral (SO) regimen were followed up at 6 months. Sixty-two (84.9 %) patients of LO, and 11 (67.9 %) patients of SO regimen achieved microbiologic improvement in one sample. Clinical improvement occurred in the majority. Forty-five (60.8 %) patients of LO and six (35.3%) patients of SO regimen required treatment modification, and the major reason was intolerability due to peripheral neuropathy. Skin pigmentation (43.8%), anemia (35.6%), and thrombocytopenia (26%) were other common adverse events (AEs), and optic neuritis occurred in two patients in the LO regimen. Hepatitis and thrombocytopenia occurred commonly with regimens combining bedaquiline and delamanid. Linezolid dose was reduced in 45.2% and the drug was replaced in 17.8%, commonly by pyrazinamide and delamanid. Conclusion: Interim microbiological outcomes with all-oral regimens of DR-TB were favorable. Extended monitoring is needed to assess the sustenance of treatment effect. AEs such as peripheral neuropathy are a major challenge and emphasize the need for newer regimens with better safety profiles.