Efficacy and safety of a novel regimen for retreated drug-sensitive pulmonary tuberculosis

To evaluate efficacy, safety and long-term recurrence rate of a novel regimen for retreated drug-sensitive pulmonary tuberculosis (TB) to optimize treatment strategies. A prospective multicenter observational cohort study enrolled 584 patients with retreated drug-sensitive pulmonary TB across 31 designated TB hospitals in China from January 2009 to June 2021. Group assignment was based on the regimen routinely used at each participating center. The participants were categorized into experimental group (novel regimen 4HL 2 EZS(Lfx)/4HL 2 E) (where L 2 denoted rifapentine administered twice weekly and levofloxacin (Lfx) was used as a substitute for streptomycin (S)) or control group (standardized regimen 2HREZS/6HRE or 3HREZ/6HRE). Multivariable regression models were used to adjust for core baseline confounders. The treatment success rate was significantly higher in experimental group than control group (aOR = 1.988, 95%CI: 1.307–3.024, P = 0.001). The treatment failure rate was significantly lower in experimental group (aOR = 0.153, 95%CI: 0.072–0.325, P < 0.001). No significant differences were observed between the groups in sputum culture conversion rate at the end of second month or loss to follow-up rate (all P > 0.05). The control group had higher odds of recurrence (aOR = 5.512, 95%CI: 1.602–18.970, P = 0.007), but only 13 events occurred and the confidence interval was wide, indicating substantial uncertainty. Kaplan-Meier analysis suggested a lower cumulative recurrence rate in the experimental group throughout follow-up. Exploratory subgroup analyses showed high point estimates in male, female, middle-aged patients and patients enrolled during the 11th and 13th Five-year plan periods. The novel regimen for retreated drug-sensitive pulmonary TB can significantly improve the treatment success and reduce the treatment failure without increasing adverse events.