A Short-Course Regimen Containing Delamanid, Bedaquiline and Linezolid for the Treatment of Drug-Resistant Tuberculosis: A Retrospective Study from China.

Abstract

Purpose: To assess the efficacy and safety of delamani (Dlm), bedaquiline (Bdq) and linezolid (Lzd) in multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant tuberculosis (RR-TB).

Patients and methods: We retrospectively analyzed the clinical data of 71 patients with MDR/RR-TB. All patients were given a 6-9 month short-course treatment based on Dlm, Bdq and Lzd. Outcomes included treatment success, sputum culture conversion rate and time, clinical and imaging improvement, adverse events (AEs), serious adverse events (SAEs), and QTcF prolongation were recorded. Logistic regression and Cox proportional hazards models were used to identify factors associated with treatment success and time to sputum culture conversion, respectively.

Results: 57.75% of patients were male, and the median (IQR) age of all patients was 42.00 (30.50, 54.00) years. At the end of the treatment, 73.24% of patients achieved a good therapeutic outcome, 85.19% of patients achieved negative sputum culture, and the median (IQR) time for sputum culture to turn negative was 62.50 (28.00, 126.00) days. The clinical symptoms of the patients were all significantly improved (P < 0.001). 94.37% of patients showed lesion absorption, and the proportion of lesion area/volume to the whole lung was significantly reduced (P < 0.001). 36.62% of patients developed any grade AEs, the incidence of grade ≥3 AEs was 8.45%, and one patient (1.41%) developed SAEs, which was grade 4 anemia caused by Lzd. 12.68% of patients experienced prolonged QTcF. Previous history of tuberculosis (OR = 0.188, P = 0.015) and hepatitis B (OR = 0.150, P = 0.038) was associated with non-favorable outcomes. No baseline characteristics were associated with time to sputum culture conversion (P > 0.05).

Conclusion: The Dlm-Bdq-Lzd regimen demonstrated favorable efficacy and safety in patients with MDR/RR-TB, and may represent a mechanistically distinct, shorter-course alternative to conventional regimens, while potential risks such as prolonged QTcF need to be noted.