Preliminary results of 24-36 weeks of bedaquiline, delamanid, clofazimine and pyrazinamide for the treatment of MDR/RR-TB.

<bold>Background:</bold> MDR-TB presents a persistent global public health crisis. Our preliminary research identified a promising four-drug regimen for effectively treating MDR-TB. <bold>Methods:</bold> We conducted a prospective, randomized, multicenter study in China to evaluate the efficacy and safety of an innovative oral regimen for MDR/RR-TB. The regimen included bedaquiline, delamanid, clofazimine, and pyrazinamide for 24-36 weeks. <bold>Results:</bold> Recruitment for the study began on June 2, 2021, enrolling 58 patients randomly assigned to control group (18-20 months WHO-recommended regimen) or experimental groups. By November 30, 2023, 29 patients in the experimental group and 18 in the control group completed treatment and were analyzed. The experimental group achieved a treatment success rate of 82.76% (24/29) compared to 72.22% (13/18) in the control group (OR=0.542[95% CI 0.132 to 2.222], p=0.473). Sputum culture conversion rates at 2 months were significantly higher in the experimental group (93.1%) compared to the control group (62.06%) (p<0.05), with a similar trend at 6 months (100% vs 83.33%, p<0.05). Experimental group reported fewer adverse reactions than control group (36 vs 51 occurrences), and no severe adverse reactions occurred in either group. Experimental group reported one case of relapse as of December 2023. <bold>Conclusions:</bold> Preliminary results indicate that the innovative all-oral regimen shows comparable effectiveness to WHO-recommended regimens for treating MDR/RR-TB. This regimen exhibits higher sputum culture conversion rates, and fewer adverse reactions. These findings suggest the potential for wider utilization of this regimen. More data will be released soon.