Evaluation of the Efficacy and Tolerability of Bedaquiline in Drug-Resistant Tuberculosis

Abstract

Introduction: Multidrug-resistant tuberculosis (TB) poses a serious threat to public health globally because of limited treatment options and high levels of antimicrobial resistance. Bedaquiline is an important component of contemporary multidrug treatment regimens for drug-resistant TB. This study aimed to evaluate treatment outcomes and tolerability among patients receiving a bedaquiline-containing regimen, including sputum conversion, laboratory parameters, adverse drug reactions (ADRs), and treatment compliance. Materials and methods: The study was a hospital-based prospective observational study conducted among 64 patients with drug-resistant TB who attended the drug-resistant TB clinic at Zydus Medical College and Hospital, Dahod, from April 2024 to September 2025. Patients on a bedaquiline-based regimen were followed up monthly to assess sputum conversion, laboratory tests, ADRs, and treatment compliance. Results: Among 64 patients with drug-resistant TB, sputum conversion was achieved in 61 (95.3%), with no significant association between conversion and baseline demographic or clinical characteristics (all p > 0.05). Universal rifampicin resistance (100%) and high levels of isoniazid resistance were observed, whereas susceptibility was observed in 98.4% of isolates to injectable anti-TB drugs and in 64.1% to moxifloxacin. These in vitro drug susceptibility findings should not be interpreted as evidence of comparative clinical efficacy. Follow-up demonstrated preserved renal function, with mild but significant changes in liver function and electrolytes, whereas nausea (13, 20.3%) and electrolyte abnormalities (15, 23.4%) were the most frequent ADRs. Conclusions: A high sputum conversion rate of 95.3% (61/64) was observed during follow-up among patients receiving a bedaquiline-containing multidrug regimen. Most reported adverse events were mild; however, biochemical changes and QT prolongation were observed and require continued clinical monitoring. Given the prospective observational design, the absence of a comparator group, the concomitant use of multiple anti-TB drugs, and the limited follow-up duration, the independent contribution of bedaquiline to the observed treatment outcomes, as well as its long-term efficacy and safety, cannot be determined from the present study.