THE EFFECTIVENESS AND SAFETY OF BEDAQUILINE, PRETOMANID, AND LINEZOLID (BPaLM)–BASED REGIMENS FOR RIFAMPICIN-RESISTANT TUBERCULOSIS —A PROSPECTIVE COHORT STUDY IN BAHRAICH DISTRICT OF UTTAR PRADESH
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Keywords
Bedaquiline; Pretomanid; Linezolid; Moxifloxacin; Rifampicin-resistant tuberculosis; MDR-TB; BPaLM regimen.
Abstract
Tuberculosis (TB) remains a significant global health concern, with India contributing nearly 27% of global TB cases. The emergence of rifampicin-resistant and multidrug-resistant TB (RR/MDR-TB) challenges national elimination goals. Traditional long-course regimens have shown limited adherence and substantial toxicity. In 2022, the World Health Organization (WHO) and India’s National Tuberculosis Elimination Programme (NTEP) endorsed a shorter 6-month, all-oral regimen containing Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin (BPaLM). This study evaluates the real-world effectiveness and safety of the BPaLM regimen in a district-level cohort in Bahraich, Uttar Pradesh.
Aim: To assess the effectiveness and safety profile of the BPaLM regimen in microbiologically confirmed rifampicin-resistant TB patients at the District Tuberculosis Hospital, Bahraich Medical College, Uttar Pradesh.
Method: A prospective observational cohort study was conducted from July to September 2025 involving 50 confirmed RR-TB patients initiated on the standardized 24-week BPaLM regimen under directly observed therapy (DOT). Clinical, microbiological, and laboratory assessments were performed at baseline, 8, 16, and 24 weeks. Data were analyzed using SPSS v28.0, with significance set at p < 0.05.
Results: Among 50 participants (56% male; mean age 43.2 ± 14.6 years), sputum culture conversion occurred in 76%, 88%, and 92% at 8, 16, and 24 weeks, respectively. The overall treatment success rate was 92%, with no mortality. Adverse drug reactions occurred in 34% of cases, primarily mild peripheral neuropathy, anemia, and gastrointestinal intolerance, which were managed conservatively.
Conclusion: The BPaLM regimen demonstrated excellent efficacy, rapid bacteriological conversion, and good tolerability under programmatic conditions. It represents a practical, short, and effective therapeutic option for managing RR/MDR-TB in India’s district-level settings.
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Dr Rahul Agarwal
Associate Professor Department of Pharmacology MSD ASMC & MBH Bahraich,UP
Dr Mukesh Kumar
Assistant Professor Department of Pharmacology Gouri Devi Institute of Medical Sciences,Durgapur, West Bengal
Dr Joydip Das
Assistant Professor Department of Pharmacology, College of Medicine &Sagore Dutta Hospital, Kamarhati , Kolkata
Dr Vishal Prakash Giri
Professor & Head Department of Pharmacology, Autonomous State Medical College Shahjahanpur, UP
Dr Rajiv Mishra
Professor & Head Department of Pharmacology TS Mishra Medical College Lucknow
Dr Sudip Barua
Assistant Professor Department of Pharmacology, College of Medicine & Sagore Dutta Hospital, Kamarhati , Kolkata
Dr Shakti Bala Dutta
Professor Department of Pharmacology, SGRRIM&HS , Dehradun , Uttarakhand