Early Real-World Experience with the BPaLM Regimen for Multidrug-Resistant Tuberculosis in India: A Prospective Observational Study

Introduction: India has a high prevalence of drug-resistant tuberculosis (DR-TB). Conventional regimens for the treatment of resistant TB have low efficacy, numerous adverse effects, long duration, and high cost. After approval by the World Health Organization, an all-oral short-course regimen including bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) was adopted in India for the treatment of multidrug-resistant (MDR) tuberculosis in 2024. Data from the use of this regimen in India are limited. Aims and objectives: This study was carried out to evaluate the real-world effectiveness and safety of the BPaLM regimen in India. Materials and methods: A prospective observational study was carried out at a private medical college in Maharashtra, India. Eligible patients with the diagnosis of MDR and pre-extensively drug-resistant TB were given the BPaLM regimen as per National Tuberculosis Elimination Programme guidelines. Monthly follow-up was done with clinical examination, complete blood count, electrocardiogram, and culture. Adverse drug reactions (ADRs) were noted and managed as per guidelines. The outcome measures were cure rate, treatment completion rate, treatment success rate, time to culture conversion, and ADR profile. Results: Ten patients with MDR TB (eight pulmonary and two extra-pulmonary) were enrolled in the study. The mean (standard deviation) age was 38 (19.5) years, with 60% males. More than half the patients developed ADRs, most of which were grade 2 and manageable. The common ADRs were peripheral neuropathy (50%), myelosuppression (20%), and QT interval prolongation (20%). None of the patients required a change in regimen due to ADRs. The mean (SD) time to culture conversion was 93 (6.16) days. The cure rate was 50%, the treatment completion rate was 100%, and the treatment success rate was 100%. Conclusion: The BPaLM regimen demonstrated encouraging early treatment outcomes and an acceptable safety profile in this small prospective cohort.