Bedaquiline

(Sirturo®)

Sirturo®

Drug updated on 4/15/2024

Dosage FormTablet (oral; 20 mg, 100 mg)
Drug ClassDiarylquinoline antimycobacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

Latest News

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Summary
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  • Bedaquiline (Sirturo) is indicated as part of combination therapy in adult and pediatric patients with pulmonary multi-drug resistant tuberculosis (MDR-TB), particularly when an effective treatment regimen cannot otherwise be provided.
  • Eighteen systematic reviews/meta-analyses were examined to gather information about the safety and efficacy of bedaquiline compared to other drugs for treating MDR-TB.
  • One study highlighted that bedaquiline contributed to a shorter sputum culture conversion time in DR-TB patients, marking an important metric of treatment effectiveness. Various factors like patient demographics and baseline health status influence this outcome.
  • Results showed reasonable rates of culture conversion at six months when comparing bedaquiline with delamanid or their combined use. Bedaquiline held a slight edge in efficacy when used alone.
  • The incidence rate for adverse events varied across studies, but QTc prolongation was identified as a significant concern associated with bedaquiline treatment. Despite this, serious adverse events necessitating discontinuation were relatively low, which supports its safety profile for treating MDR/XDR TB cases.
  • Compared to other drugs such as Kanamycin or combinations thereof, bedaquiline demonstrated fewer adverse effects along with better overall outcomes, presenting a favorable option.
  • For subgroups co-infected by HIV alongside DR-TB, regimens containing bedaquiline have been observed to contribute to higher success rates, thus emphasizing its importance within these vulnerable population groups.
  • Bedaquiline's role becomes critical in managing complex pre-XDR/TD & XDR/TD cases, especially where limited treatment options are available due to a high burden among MDR-TB instances.

Product Monograph / Prescribing Information

Document TitleYearSource
Sirturo (bedaquiline) Prescribing Information.2023Janssen Therapeutics, Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Time to sputum culture conversion and its associated factors among drug-resistant tuberculosis patients: a systematic review and meta-analysis.2024BMC Infectious Diseases
Efficacy and safety of bedaquiline and delamanid in the treatment of drug-resistant tuberculosis in adults: a systematic review and meta-analysis.2024Indian Journal of Tuberculosis
Favorable outcome of individual regimens containing bedaquiline and delamanid in drug-resistant tuberculosis: a systematic review.2023International Journal of Mycobacteriology
Epidemiology of extensively drug-resistant tuberculosis among patients with multidrug-resistant tuberculosis: a systematic review and meta-analysis. 2023International Journal of Infectious Diseases (IJID)
Identifying patients with multidrug-resistant tuberculosis who may benefit from shorter durations of treatment. 2023PLOS ONE
Bedaquiline's safety profile monitoring in India: considerations for future - a systematic review. 2023Current Drug Safety
Efficacy and tolerability of concomitant use of bedaquiline and delamanid for multidrug- and extensively drug-Resistant tuberculosis: a systematic review and meta-analysis. 2023Clinical Infectious Diseases
The efficacy and safety of bedaquiline in the treatment of pulmonary tuberculosis patients: a systematic review and meta-analysis. 2023Antibiotics
Efficacy and safety of bedaquiline containing regimens in patients of drug-resistant tuberculosis: an updated systematic review and meta-analysis2023Journal of Clinical Tuberculosis and Other Mycobacterial Diseases
Bedaquiline-containing regimens and multidrug-resistant tuberculosis: a systematic review and meta-analysis.2022Brazilian Journal of Pulmonology
Bedaquiline and linezolid improve anti-TB treatment outcome in drug-resistant TB patients with HIV: a systematic review and meta-analysis. 2022Pharmacological Research
Effectiveness of the novel anti-TB bedaquiline against drug-resistant TB in Africa: a systematic review of the literature. 2022Pathogens
Acquired bedaquiline resistance during the treatment of drug-resistant tuberculosis: a systematic review. 2022JAC-Antimicrobial Resistance
Efficacy of bedaquiline in the treatment of drug-resistant tuberculosis: a systematic review and meta-analysis.2021BMC Infectious Diseases
The efficacy of bedaquiline versus kanamycin in multi-drug resistant tuberculosis: a systematic scoping review. 2021Health SA Gesondheid
Bedaquiline for the treatment of multidrug-resistant tuberculosis in the United States. 2020Clinical Infectious Diseases

Clinical Practice Guidelines