Comparative Analysis of Treatment Outcomes in Drug-Resistant Tuberculosis Patients with and without Bedaquiline in Pakistan: A Retrospective Cohort Study

Abstract

Background: Multidrug-resistant tuberculosis (MDR-TB) poses a significant threat to global TB control, with new drugs such as bedaquiline being introduced to improve treatment outcomes. This study aimed to compare the treatment outcomes of drug-resistant TB (DR-TB) patients treated with and without bedaquiline.

Methods: We conducted a retrospective cohort analysis of 450 patients registered in Pakistan's rifampicin-resistant tuberculosis case registry (ENRS) between January 1, 2015, and December 31, 2022. Of these, 32 patients received bedaquiline, while 418 did not. Key demographic and clinical characteristics were compared between groups. Kaplan-Meier survival analysis was performed to assess survival probabilities. The primary outcomes were treatment success, failure, loss to follow-up (LTFU), and mortality.

Results: No significant difference in overall treatment success was observed between patients treated with bedaquiline (81.3%) and those without bedaquiline (78.9%) (p=0.75). Both groups had a high cure rate, with 75.0% of bedaquiline-treated patients and 74.6% of non-bedaquiline patients achieving a cure (p=0.85). However, no treatment failures were recorded in the bedaquiline group, compared to a 4.8% failure rate in the non-bedaquiline group. Kaplan-Meier survival analysis revealed similar survival probabilities between MDR-TB and rifampicin-resistant TB patients, irrespective of bedaquiline use. Urban residence was significantly associated with bedaquiline use (p=0.007), suggesting better access to newer treatments in urban areas.

Conclusion: Although bedaquiline did not significantly alter overall treatment outcomes in this cohort, its use appears to prevent treatment failure, particularly in complex DR-TB cases. Sociodemographic factors, such as urban residence, are critical in determining bedaquiline access. Equitable access to advanced TB therapies and optimizing bedaquiline use in combination regimens remain essential for improving MDR-TB treatment outcomes. Further research is needed to explore the long-term impact of bedaquiline in diverse populations.