19 Jun 2023 • In a recent study published in the journal Clinical Infectious Diseases, researchers reported on the treatment of rifampin-resistant tuberculosis in the United States using the FDA approved bedaquiline, pretomanid, and linezolid (BPaL) therapy. In 2019, a 6-month oral regimen of bedaquiline, pretomanid, and linezolid (BPaL) was approved in the U.S. for patients with rifampin-resistant tuberculosis (RR-TB) or those intolerant to rifampin based on the NIX-TB trial conducted in South Africa.

In a retrospective analysis of patients treated in the U.S., no initial failures occurred after a 6-month oral course of bedaquiline, pretomanid, and linezolid. Out of the 70 patients who were administered the BPaL treatment regimen, two patients successfully converted to rifampin-based therapy, while the remaining 68 were able to complete the BPaL treatment regimen. However, two of these 68 patients had a relapse after the completion of the BPaL regimen. The median BPaL duration was 6 months.

Linezolid dosing was changed from an initial 600 mg daily in 42 patients (62%). In 36 instances, this change was based on TDM(Therapeutic Drug Monitoring) results. In 6 other cases, linezolid was reduced or discontinued because of worsening anemia or worsening peripheral neuropathy.

Overall, the BIG cohort demonstrates that early implementation of new tuberculosis treatments in the U.S. is feasible. In this cohort, effective treatment required less than half the duration recommended in ATS/CDC/ERS/IDSA 2019 guidelines for drug-resistant tuberculosis. Use of individualized linezolid dosing and monitoring likely enhanced safety and treatment completion.

Source: Clinical Infectious Diseases | Read full story