Summary

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• Sirturo (bedaquiline) is indicated as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve Sirturo for use when an effective treatment regimen cannot otherwise be provided.
• This summary is based on the review of 16 systematic review(s)/meta-analysis(es). ^[1-16]
• Sputum Culture Conversion: Pooled median time to sputum culture conversion in DR-TB patients was 68.57 days (IQR 61.01, 76.12). Conversion rates at 6 months ranged from 61% to 95% for bedaquiline and delamanid. Improved conversion rates were observed at 24 weeks (RR = 1.27, 95% CI: 1.10 to 1.46) and during follow-up (RR = 1.33, 95% CI: 1.06 to 1.66) in RCTs.
• Treatment Success and Cure Rates: Bedaquiline-containing regimens increased cure rates (RR = 1.60, 95% CI: 1.13 to 2.26) and decreased failure rates (RR = 0.56, 95% CI: 0.56 to 0.88). Pooled treatment success rates were 74.7% (95% CI: 69.8-79.0) in observational studies and 86.1% (95% CI: 76.8-92.1) in experimental studies.
• Mortality: Pooled proportion of all-cause mortality at 6 months in the bedaquiline cohort was 0.074 (p < 0.001). Reduced mortality was observed (RR = 0.68, 95% CI: 0.48 to 0.97) in non-randomized studies.
• Treatment Duration: Use of bedaquiline was associated with a reduction in treatment duration by 0.51 months.
• The incidence of adverse events in the bedaquiline cohort ranged from 11.1% to 95.2%, with common adverse events including peripheral neuropathy (50%) and QTc prolongation (43%).
• Bedaquiline use was associated with an increased incidence of cardiotoxicity (RR = 4.54, 95% CI: 1.74 to 11.87) and grade 3-5 adverse events (RR = 1.42, 95% CI: 1.17 to 1.73), with QTc prolongation occurring in 0.163 of the cohort (p < 0.001).
• The incidence of QTc prolongation was higher in the delamanid cohort (0.344) compared to the bedaquiline cohort (0.163); the combined use of bedaquiline and delamanid showed a pooled QTc prolongation rate of 7.8% (95% CI: 4.1-11.6%).
• Sputum culture conversion times were longer in subgroups including females, individuals with a history of alcohol use, smoking, second-line drug use, BMI < 18.5 kg/m², lung cavities, and higher sputum smear grading at baseline. Additionally, higher CD4 T-cell counts at baseline correlated with better treatment success rates among DR-TB-HIV patients. Geographical variations were noted, with data from multiple regions, including Africa.