BPaL regimen tied to liver injury

The overall risk of drug-induced liver injury (DILI) with the pretomanid, bedaquiline and linezolid (BPaL) regimen is lower compared with the isoniazid, rifampin, pyrazinamide and ethambutol (HRZE) regimen, a study has shown. However, the association between BPal and DILI remains significant, suggesting the need for careful monitoring during treatment.

Overall, 1,242 patients had BPaL-related DILI, of whom the majority (63.8 percent) were aged <65 years and more than half (51.4 percent) were male. The median onset time for DILI was significantly shorter with the BPaL regimen compared with the HRZE regimen (8 vs 20 days; p<0.001). In addition, the BPaL regimen correlated with a higher risk DILI-related mortality (14.1 percent vs 10.4 percent; p=0.003).

On the other hand, a stronger association between DILI and antituberculosis drugs was observed with the HRZE regimen (odds ratio [OR], 7.99, 95 percent confidence interval [CI], 7.74‒8.25) than the BPaL regimen (OR, 4.75, 95 percent CI, 4.55‒4.97).

In this retrospective pharmacovigilance analysis, a team of investigators obtained data from the US Food and Drug Administration Adverse Event Reporting System databases from July 2019 to June 2023. They performed a disproportionality analysis to calculate the reporting ORs of DILI for each component of the BPaL regimen and compared the onset time and mortality rates of DILI across different regimens.