Effectiveness and safety of the BPaL regimen in the Philippines.

Background: Treatment success among multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) patients in the Philippines increased with the introduction of a 9-month all-oral treatment regimen; however, this remained sub-optimal, and patients continued to endure the burdensome and toxic effects of component medicines. In 2022, the World Health Organization recommended a 6-month MDR-TB regimen (bedaquiline, pretomanid, and linezolid or BPaL given for 26 weeks). Method: Operational research was conducted in 12 TB treatment centers in 10 regions in the Philippines using the BPaL regimen. From June 2021 to December 2022, patients with pre-extensively drug-resistant TB or MDR/RR-TB that was treatment intolerant or nonresponsive to a previous MDR-TB regimen were enrolled. Linezolid was started daily at either 1200 mg or 600 mg. Results: A total of 103 patients received the BPaL regimen; 96 patients were included in the cohort analysis. Despite fluoroquinolone resistance in 42 %, cavitary TB 31 %, diabetes mellitus 42 %, and HIV coinfection 8 %, treatment success was 98 %, with 1 (1 %) death and 1 (1 %) patient not evaluated. Sputum culture conversion was 78 % at month 1 of treatment, and 96 % by month 4. Sustained success at 6 and 12 months post-treatment were 92 % and 90 %, respectively, with the remainder attributable to patients not returning for post-treatment follow-up.Adverse events were mostly grade 1-2, which fully resolved in almost all patients. Linezolid dose modifications, and BPaL regimen interruption occurred in 66 % and 18 %, respectively. Conclusion: The BPaL regimen had a remarkably high treatment success, rapid culture conversion, and a manageable safety profile among MDR/RR-TB patients in this study despite fluoroquinolone resistance and comorbidities.