Real-world data on combination treatment with bedaquiline in patients with multidrug-resistant pulmonary tuberculosis in Japan: An interim analysis of post-marketing surveillance.

BACKGROUND

An observational post-marketing surveillance (PMS) is being conducted to evaluate the long-term safety and effectiveness of bedaquiline as part of combination therapies in treating pulmonary multidrug-resistant tuberculosis (MDR-TB) in Japan.

METHODS

This interim analysis includes patients with MDR-TB who started bedaquiline-containing anti-tuberculosis (TB) drugs in Japan between January 2018 and September 2022. Outcomes include the incidence of adverse drug reactions (ADRs) and negative sputum cultures.

RESULTS

In total, 112 patients were included in the safety analysis. All patients were receiving anti-TB drugs in addition to bedaquiline at baseline; 96.4 % were receiving ≥3 drugs. The most commonly used concomitant anti-TB drugs were delamanid, cycloserine, linezolid, and levofloxacin hydrate. At 24 weeks after bedaquiline initiation, in the effectiveness analysis set, 19/20 (95.0 %) had negative sputum mycobacteria growth indicator tube cultures and 9/12 (75.0 %) have negative solid medium cultures. Patients received bedaquiline for a median of 186.0 days, during which 85 ADRs occurred in 45 patients (40.2 %). The top three ADRs were electrocardiogram QT prolonged (9.8 %), nausea (7.1 %), and hepatic function abnormal (4.5 %).

CONCLUSIONS

This interim analysis of a PMS supports the long-term safety and effectiveness of bedaquiline for MDR-TB in Japan. ADRs were consistent with previous reports and no new safety signals were detected. The final analysis of this ongoing PMS will be expected to confirm these findings.