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September 10, 2025Open Access

Effect of Bdq-Containing Regimen and Molecular Detection of Bdq Resistance among Pre-XDR-TB Patients with Unfavorable Outcomes

Key Points

Bedaquiline treatment led to favorable outcomes in 89.13% of patients compared to 52.63% in the non-Bdq group, indicating its efficacy.
Logistic regression analysis showed that bedaquiline use was an independent predictor of treatment success with an odds ratio of 11.572.
Whole-genome sequencing identified specific mutations associated with bedaquiline resistance in patients with unfavorable outcomes.
Findings highlight the necessity for ongoing drug resistance monitoring and the urgent need for affordable access to novel TB treatments.

Abstract

The objective of this study was to evaluate the efficacy of bedaquiline (Bdq) -containing regimens in pre-extensively drug-resistant tuberculosis (pre-XDR-TB) patients in Shenzhen, China, and to investigate the association between Bdq resistance and unfavorable outcomes. Data were collected from 84 pre-XDR-TB patients categorized into Bdq (n = 46) and non-Bdq (n = 38) groups. Individuals in the Bdq group were treated with Bdq alongside individualized background drugs. Commonly used drugs (>50% of patients) in both groups were linezolid (Lzd), clofazimine (Cfz), cycloserine (Cs) and pyrazinamide (Pza). Treatment outcomes were classified as cure, treatment completion, treatment failure, loss to follow-up, or death. Logistic regression analysis was conducted to determine independent predictors of treatment success using potential risk factors, including age, sex, body mass index (BMI), TB treatment history, and other factors. Whole-genome sequencing (WGS) was conducted on clinical isolates from 4 patients with unfavorable outcomes and 4 patients with favorable outcomes in the Bdq group. Favorable treatment outcomes were observed in 89. 13% (41/46) of the Bdq group and 52. 63% (20/38) of the non-Bdq group (P = 0. 0005). Univariate and multivariate analyses identified Bdq was an independent factor associated with treatment success (odds ratio OR = 11. 572, 95% CI: 2. 183-61. 343, P = 0. 004). WGS identified an atpEAla63Pro mutation conferring Bdq resistance in one patient with an unfavorable outcome. Additional resistance mutations included Rv0678Arg156fs (Bdq and Cfz resistance) and rplCCys154Arg (Lzd resistance). Bdq-containing regimens significantly improved the treatment outcomes among pre-XDR-TB patients. The emergence of resistance mutations highlights the importance of routine drug resistance monitoring and rational drug use. Expanding access to Bdq and other novel drugs at affordable prices is vital for improving the success of pre-XDR-TB treatment.

Effect of Bdq-Containing Regimen and Molecular Detection of Bdq Resistance among Pre-XDR-TB Patients with Unfavorable Outcomes

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