ADVERSE DRUG REACTIONS IN BEDAQUILINE-BASED REGIMENS FOR DRUG-RESISTANT TB UNDER NTEP: A PROSPECTIVE STUDY FROM WESTERN INDIA

Abstract

Introduction: Drug-resistant tuberculosis (DR-TB) remains a major public health challenge. Although Bedaquiline-based all-oral regimens have improved treatment outcomes, adverse drug reactions (ADRs) may affect adherence and treatment success. This study was conducted to describe the incidence, type, severity, and management of ADRs in DR-TB patients on BDQ-based all-oral longer regimens under NTEP at a tertiary care hospital in Western India. Methodology: A prospective observational study was conducted among 50 microbiologically confirmed DR-TB patients receiving Bedaquiline-based all-oral regimens at a tertiary care hospital in Western India. Patients were monitored through clinical assessment, ECG, hematological, hepatic, renal, and neurological evaluations. ADRs were assessed using active drug safety monitoring and management protocols. Results: At least one ADR occurred in 26 (52%) patients. Peripheral neuropathy (18%), QTc prolongation (16%), and anemia (12%) were the most common ADRs. QTc >500 ms occurred in 2 (4%) patients and was managed with temporary Bedaquiline interruption. Treatment modification was required in 7 (14%) patients, while no ADR-related deaths were reported. Conclusion: Bedaquiline-based all-oral regimens demonstrated an acceptable safety profile in DR-TB patients. Most ADRs were mild to moderate and manageable, highlighting the importance of active pharmacovigilance for safe programmatic implementation.