Efficacy and safety of a 4-month quabodepistat, delamanid, and bedaquiline regimen for drug-susceptible pulmonary tuberculosis: a multicentre, open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trial.

In 30 seconds

This multicentre, open-label, randomised, proof-of-concept trial evaluated a 4-month regimen of delamanid, bedaquiline, and quabodepistat (DBQ) in 122 adults with drug-susceptible pulmonary tuberculosis. The primary outcome, sputum culture conversion, was achieved in 96.0% of participants in the pooled DBQ group, demonstrating non-inferiority compared to the 6-month standard regimen (RHEZ).

Key findings

• Sputum culture conversion was 100.0% in the DBQ10 group and 96.0% in the pooled DBQ group.
• The non-inferiority margin was met with a difference of -4.0% between the pooled DBQ and RHEZ groups.
• Adverse events were mostly mild to moderate, with 87% of participants experiencing at least one treatment-emergent adverse event.
• The most common adverse events included upper respiratory tract infection (30%) and headache (20%).

Why it matters

The findings suggest that a shorter, 4-month treatment regimen with DBQ may be as effective as the standard 6-month therapy for drug-susceptible pulmonary tuberculosis, potentially improving patient adherence and reducing treatment burden.